<DOC>
[108th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:86641.wais]
POINT, CLICK, SELF-MEDICATE: A REVIEW OF CONSUMER SAFEGUARDS ON
INTERNET PHARMACY SITES
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
MARCH 27, 2003
__________
Serial No. 108-5
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri
CHRIS CANNON, Utah DIANE E. WATSON, California
ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee LINDA T. SANCHEZ, California
JOHN SULLIVAN, Oklahoma C.A. ``DUTCH'' RUPPERSBERGER,
NATHAN DEAL, Georgia Maryland
CANDICE S. MILLER, Michigan ELEANOR HOLMES NORTON, District of
TIM MURPHY, Pennsylvania Columbia
MICHAEL R. TURNER, Ohio JIM COOPER, Tennessee
JOHN R. CARTER, Texas CHRIS BELL, Texas
WILLIAM J. JANKLOW, South Dakota ------
MARSHA BLACKBURN, Tennessee BERNARD SANDERS, Vermont
(Independent)
Peter Sirh, Staff Director
Melissa Wojciak, Deputy Staff Director
Randy Kaplan, Senior Counsel/Parliamentarian
Teresa Austin, Chief Clerk
Philip M. Schiliro, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on March 27, 2003................................... 1
Statement of:
Beales, J. Howard, Director of the Bureau of Consumer
Protection, Federal Trade Commission; and William Hubbard,
Senior Associate Commissioner for Policy Planning and
Legislation, Food and Drug Administration.................. 25
Thompson, Dr. James, M.D., executive vice president, chief
executive officer, Federation of State Medical Boards;
Carmen Catizone, executive director, National Association
of Boards of Pharmacy; and Richard Blumenthal, attorney
general, State of Connecticut, on behalf of the National
Association of Attorneys General........................... 100
Letters, statements, etc., submitted for the record by:
Beales, J. Howard, Director of the Bureau of Consumer
Protection, Federal Trade Commission, prepared statement of 27
Bell, Hon. Chris, a Representative in Congress from the State
of Texas, prepared statement of............................ 19
Blumenthal, Richard, attorney general, State of Connecticut,
on behalf of the National Association of Attorneys General,
prepared statement of...................................... 141
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 11
Catizone, Carmen, executive director, National Association of
Boards of Pharmacy, prepared statement of.................. 116
Davis, Chairman Tom, a Representative in Congress from the
State of Virginia, prepared statement of................... 3
Hubbard, William, Senior Associate Commissioner for Policy
Planning and Legislation, Food and Drug Administration,
prepared statement of...................................... 44
Ruppersberger, Hon. C.A. Dutch, a Representative in Congress
from the State of Maryland, prepared statement of.......... 21
Thompson, Dr. James, M.D., executive vice president, chief
executive officer, Federation of State Medical Boards,
prepared statement of...................................... 103
Tierney, Hon. John F., a Representative in Congress from the
State of Massachusetts, prepared statement of.............. 24
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of................. 6
POINT, CLICK, SELF-MEDICATE: A REVIEW OF CONSUMER SAFEGUARDS ON
INTERNET PHARMACY SITES
----------
THURSDAY, MARCH 27, 2003
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:26 a.m., in
room 2154, Rayburn House Office Building, Hon. Tom Davis of
Virginia (chairman of the committee) presiding.
Present: Representatives Davis of Virginia, Burton, Platts,
Putnam, Duncan, Miller, Murphy, Turner, Janklow, Waxman, Towns,
Sanders, Maloney, Cummings, Kucinich, Tierney, Watson, Lynch,
Van Hollen, Ruppersberger, and Bell.
Staff present: Peter Sirh, staff director; Melissa Wojciak,
deputy staff director; Ellen Brown, legislative director and
senior policy counsel; Scott Kopple, deputy director of
communications; Teresa Austin, chief clerk; Joshua E.
Gillespie, deputy clerk; Susie Schulte, legislative assistant;
Corinne Zaccagnini, chief information officer; Anne Marie
Turner, counsel; Phil Barnett, minority chief counsel; Josh
Sharfstein, minority professional staff member; Earley Green,
minority chief clerk; Jean Gosa, minority assistant clerk; and
Cecelia Morton, minority office manager.
Chairman Tom Davis. Good morning. The committee will come
to order.
I want to welcome everybody to today's oversight hearing on
the domestic sale of drugs on Internet pharmacy sites.
The sale of consumer products over the Internet has grown
exponentially over the last 10 years. Clearly, access to
prescription drugs via online pharmacies can provide benefits
to consumers, including convenience and reduced cost. But,
while many online pharmacies operate in the same manner as
traditional brick-and-mortar drug stores and comply with the
standards of State licensing authorities, not all pharmacies
practicing over the Internet are legitimate sites.
The Internet creates an easy environment for illegitimate
sites to bypass traditional regulations and established
safeguards for the sale of prescription drugs. Public health
and consumer safety issues arise when the sale of prescription
drugs occurs without a valid prescription or adequate physician
supervision. It is now very simple to obtain virtually any
medication online without ever seeking or speaking with a
physician. All a consumer has to do is type the name of the
drug into a search engine, quickly identify a site selling the
medication, and then click to purchase. Although some sites
require the consumer to fill out a health questionnaire to be
reviewed by a physician prior to the prescription, consumers
can easily manipulate their medical history on some
questionnaires to be approved for the drug they desire. On
other sites, no questionnaire is even required.
I think all of us here today have opened our in-boxes only
to find dozens of e-mails advertising medications at low cost
with no prescription required. The most popular of those drugs
sold online are so-called ``lifestyle'' drugs, including Viagra
and Propecia. After September 11th there was a sharp rise in
the sale of Cipro over the Internet without a prescription. The
risks of this kind of self-medicating can include adverse
reactions from inappropriately prescribed medications,
dangerous drug interactions, and use of counterfeit or tainted
products.
I think it is important to note that several of these
illegitimate sites fail to provide information about
contraindications, potential adverse effects, and efficacy.
Regulating these Internet pharmacies can be a challenge for
Federal and State enforcement capabilities. Authorities have
trouble tracking down Internet sites that fail to comply with
State licensing requirements and standards. Many don't disclose
identifying information, change their names and appearances
often, and sometimes disappear without a trace. Accountability
is impossible when the violators cannot be identified and
located.
Another regulatory challenge is the application of State
regulations across multiple jurisdictions by multiple State and
Federal authorities. Historically, States have been the primary
enforcement authority with respect to the practice of medicine
and dispensing of prescription drugs; however, the Food and
Drug administration and the Federal Trade Commission also have
a role to play.
We will hear the testimony from several witnesses to
discuss the regulatory challenges created by the domestic sale
of prescription drugs over the Internet. I want to thank all of
our witnesses for appearing here with us today.
I would now like to yield to Mr. Waxman for an opening
statement.
[The prepared statement of Chairman Tom Davis follows:]
[GRAPHIC] [TIFF OMITTED] 86641.001
[GRAPHIC] [TIFF OMITTED] 86641.002
Mr. Waxman. I would like to thank Chairman Davis for
holding this hearing today on the proliferation of domestic Web
sites that sell medications without a valid prescription. These
Web sites occupy a dark and dangerous corner of the U.S. health
care system. With the simple click of a mouse, consumers can
purchase virtually any prescription medication without knowing
who is hosting the Web site, who is writing the prescription,
or who is dispensing the drug. On these sites, no prescription
from your doctor is required. On the basis of a cursory medical
questionnaire or no questionnaire at all, an anonymous
physician prescribes medication that can be lethal.
This practice has been rejected as substandard care by the
State medical boards, and for good reason. Without a real visit
with a physician that explores the risks and benefits of a
prescription drug, a consumer can wind up suffering severe and
unnecessary side effects. Children can order drugs online
without their parents' or their doctor's knowledge.
There is also concern among experts that easy access to
antibiotics like Cipro through Internet pharmacies fosters drug
resistance and therefore threatens us all.
One reason for the persistence of Web sites selling drugs
without valid prescriptions is a gap in consumer safeguards and
Government enforcement. On one side of this gap are Federal
agencies that are charged with protecting consumers. Federal
law prohibits false and misleading advertising and requires
certain drugs only be dispensed with a prescription. However,
while Federal agencies have taken action against Web sites when
there is a clear consumer fraud, the Federal Government has
generally deferred to States on the central question of what is
a valid prescription.
On the other side of the gap are State agencies, including
boards of medicine and pharmacy, and the attorneys general.
Many States would like to shut these sites down, but often lack
the legal authority to do so. For example, if one attorney
general gets an injunction against one Web site, that
injunction applies only in one State. It should not be
necessary to require 50 separate lawsuits to shut down every
dangerous Internet site.
Today we will hear from the key agencies and organizations
on both sides of this gap. I look forward to hearing about
existing efforts to protect consumers and to discussing
possible solutions to this ongoing problem.
I want to thank all the witnesses for appearing today.
Thank you, Mr. Chairman.
[The prepared statement of Hon. Henry A. Waxman follows:]
[GRAPHIC] [TIFF OMITTED] 86641.003
[GRAPHIC] [TIFF OMITTED] 86641.004
[GRAPHIC] [TIFF OMITTED] 86641.005
Chairman Tom Davis. Thank you very much.
Any additional statements? Mr. Burton.
Mr. Burton. Mr. Chairman, thank you very much. I agree with
what Representative Waxman and you just said. Those who are
selling drugs without prescriptions over the Internet should be
prosecuted to the full extent of the law; however, 10 years ago
very few people owned a personal computer and the Internet was
only used by the military and scientific communities. Ten years
ago the Internet was available to most Government agencies and
the corporate world, and today every desk in every office of
the country has a computer hooked up to the Internet, and a
majority of American homes have at least one computer and
Internet access.
Americans can read the Congressional Record the day it is
printed. We as a population buy books, music, video games,
furniture, flowers, clothing, and airline tickets online. At
the same time, Americans' dependence on prescription drugs has
risen dramatically: 75 percent of Americans between the ages of
50 and 64 are on at least one prescription drug; 14 percent of
women age 65 are on five prescription drugs in any given weeks.
And I have friends who spend $600 or more a month on
prescription drugs. Anyone with a chronic health condition
likely is in the same situation.
The price of prescription drugs in the United States is the
highest of any country on Earth--highest of any country on
Earth. In fact, in these troubled economic times the
pharmaceutical industry is thriving. Several companies had 10
to 15 percent growth just last year and their bottom line is
unbelievable, the profits they are making. Many Americans--in
particular, our senior citizens--are looking for legitimate
ways to buy their needed prescriptions at lower prices. Other
Americans prefer the convenience of having their prescriptions
delivered directly to their home.
The technology highway, once a rough dirt road, has become
a multi-lane superhighway intersecting with Americans' avenue
of need for lower-priced prescription drugs.
As Federal officials looking at this emerging field of
Internet pharmacies, we must move forward cautiously in
determining what type of traffic controls, if any, we place on
the intersection between consumers and the lawful Internet
pharmacy. The roads and intersection already exist. Americans
should have the right to lawfully purchase prescription drugs
through licensed Internet pharmacies both in the United States
and Canada, as long as those prescriptions are valid and given
to the pharmaceutical Internet businesses.
Those who violate the law by operating illegal pharmacies
should be prosecuted. Those wholesalers who provide drugs to
non-licensed pharmacies should also be prosecuted. The
jurisdiction of parts of these roads is not that of the Federal
Government. The regulation of pharmacies and the practice of
medicine both are managed by State governments. I am a firm
believer in States' rights and do not wish for the Federal
Government to co-opt State regulatory authority.
I'm also a strong proponent of the free enterprise system
that is the underpinning of our democracy; therefore, I believe
that anything we decide to do at the Federal level must respect
rights of the State governments, the rights of lawful
businesses to operate, and the rights of Americans to use the
Internet to buy prescription drugs for which they have a
legitimate prescription at the best price available.
I look forward to hearing from our witnesses today. Today's
hearing is focused on domestic Internet pharmacies. We have
another problem relating to Internet pharmacies that we will be
addressing in a subcommittee hearing next Thursday, and that is
the ability for Americans to maintain access to lower-priced
prescription drugs through Canadian online pharmacies.
I have cosponsored legislation with Congressman Sanders and
50 other legislators at this time--and I fully believe we will
have maybe over 100 very shortly--that will institute monetary
fines on pharmaceutical companies that reduce access of
Americans to lower-cost drugs online from Canadian pharmacies.
Thank you, Mr. Chairman.
[The prepared statement of Hon. Dan Burton follows:]
[GRAPHIC] [TIFF OMITTED] 86641.006
[GRAPHIC] [TIFF OMITTED] 86641.007
[GRAPHIC] [TIFF OMITTED] 86641.008
[GRAPHIC] [TIFF OMITTED] 86641.009
Chairman Tom Davis. Thank you very much.
Any other opening statements? Mr. Towns.
Mr. Towns. Thank you very much, Mr. Chairman, for holding
this oversight hearing on safeguards on Internet pharmacy. I
would like to commend you and Ranking Member Waxman for
shedding light on this issue.
Today's Internet technology has revolutionized the purchase
and delivery of goods and services, so it should come as no
surprise that many people are utilizing this technology to
purchase prescription drugs, as well. However, what is
surprising and often frightening is the ease of which it can be
done.
The purchase of prescription drugs through the Internet
raises some very troubling safety concerns. For starters, there
is a legitimate question of whether a doctor or other medical
professionals are actually involved in the prescription drug
transaction. Even if there is a doctor, the consumer has no
assurances of the medical professional's credentials or how
thoroughly he or she reviews the medical information supplied.
A brief online questionnaire may miss essential information on
whether a specific drug is safe for a patient.
Additionally, children may try to use the Internet to get
potentially dangerous prescription drugs. Although the FDA has
the authority to take action against the sale of prescription
drugs without a valid prescription, the agency has left it up
to States to determine what is a valid prescription.
Since a person in New York can buy a prescription drug
through an Internet site based in Texas, it seems to me that
the regulatory scheme is inadequate.
I'm not in favor of shutting down all Internet pharmacy
sites; however, it appears that better oversight and control is
definitely needed. Purchasing drugs through the Internet can
offer consumers incredible benefits. It offers improved access
for home-bound patients and increases privacy for a person who
has a disease that may carry a social stigma, but we must make
sure that a licensed medical practitioner is involved in all
prescription drug transactions.
I look forward, Mr. Chairman, to hearing from the
witnesses. This is a very important hearing.
On that note I yield back.
Chairman Tom Davis. Thank you very much.
Any other opening statements over on this side? Mr.
Janklow.
Mr. Janklow. Mr. Chairman, I am going to be brief. Thank
you very much for conducting this hearing. It is obvious one of
the major problems we have in this country is people just
cannot get prescription drugs at a price that they can afford
to pay for them, and, given the utility value of the Internet,
they are able to very quickly lower the cost. It is not always
just a case of people trying to circumvent the system as much
as it is a lot of people trying to find adequate drugs.
We talk about the Canadian situation. The fact of the
matter is this Congress passed statutes that were signed into
law by the President of the United States, and the last two
Secretaries of Health and Human Services have both refused to
do the necessary documentation that the law required to deal
with the importation of drugs into the United States. For some
reason, they've chosen just not to comply with the law.
We talk about using the courts for civil actions to close
people down. The fact of the matter is a contested civil case
in America takes longer from start to finish than World War II
did. There isn't any way that we have an efficient adjudicatory
process in this country. Someone can get an injunction on the
front end, but by the time it is finished on the back end it is
several years later. And there are hundreds of these cases that
could be brought.
This is one of those rare times when, under the U.S.
Constitution, where it was envisioned that Congress would
regulate commerce between the States. This is something that's
within the unique framework of the national Government to deal
with.
Mr. Chairman, I think you have shown great insight in
moving forward on this particular issue, and I really look
forward to the testimony as to what people think we can do, as
opposed to all the brilliant things they are doing.
Thank you.
Chairman Tom Davis. Thank you very much.
Mr. Sanders.
Mr. Sanders. I apologize for jumping ahead of my colleague
here.
Chairman Tom Davis. You can yield at the end of your 5
minutes and we can get more in. That's fine. You are recognized
for 5 minutes.
Mr. Sanders. Thank you, Mr. Chairman. Mr. Chairman, thank
you for holding this important hearing. The issue of
prescription drugs is something that I have been heavily
involved in not only in my 12 years in Congress but in years
before that, as well. As my friend, Mr. Janklow indicated, the
reason for my concern is that the American people pay by far
the highest prices in the world for prescription drugs. There
are millions of senior citizens in this country who are unable
to afford prescription drugs and suffer--and in some cases
die--as a result of that reality.
Year after year the pharmaceutical industry leads every
other industry in the profits that they make while millions of
Americans are unable to afford prescription drugs. Many of
these companies pay their CEOs extravagant compensation
packages. And let us be honest and bring the real world into
this room: the pharmaceutical industry is the most powerful
lobby in the United States. In the last several years, Mr.
Chairman, the pharmaceutical industry has spent hundreds and
hundreds of millions of dollars in campaign contributions to
the vast majority of the Members of Congress, to both political
parties, especially the Republican party. The pharmaceutical
industry has spent huge sums of money on lobbying. There are
over 600 paid lobbyists from the pharmaceutical industry who
descend on this institution any time that any Member comes up
with an idea to lower the cost of prescription drugs.
Now, the reality of what is going on in America today--and
I know, Mr. Chairman, this is a little bit divergent from your
discussion, important issues that you are raising today--but
the reality is that approximately 1 million Americans are now
going to Canada in order to buy prescription drugs because the
same exact medicine sold in Canada is sold for a fraction of
the price that it's sold in the United States.
Mr. Chairman, several years ago I became the first Member
of Congress to take a group of citizens from the State of
Vermont over the Canadian border. Let me tell you one story.
Mr. Chairman, I know that you are aware of the very serious
problem of breast cancer in this country and how many women are
struggling for their lives. Timoxaphin is one of the most
widely prescribed breast cancer drugs in this country. The
women who went with me over the border were able to purchase
timoxaphin--the same, exact product, not a generic, Mr.
Chairman--for one-tenth the price, 10 percent of the price that
they're paying here in the United States.
Now, what is going on is that in the last several years--
and I'm proud to have been an active player in that process--
about 1 million Americans are either going over the border to
purchase prescription drugs in Canada or else they are
increasingly using the Internet.
Obviously, the pharmaceutical industry, which contributes
so much money in the political process, is putting a great deal
of pressure on the FDA and on Members here to say, ``No, let
the old people suffer. Let them die, because we have to protect
our profits. Don't let them go to Canada,'' although there has
not been one indication that the regulatory system in Canada is
any inferior to what we have here, not one indication, to the
best of my knowledge, that one medicine, one prescription
coming over the border has caused anybody any problems.
So, Mr. Chairman, let me go on record right now as saying
to the FDA and to Mr. Hubbard and those other people here that
we are going to fight you and we are going to try everything
that we can to prevent you from forcing people in this country
to suffer and die so that the pharmaceutical industry can
continue to rake up huge profits and provide campaign
contributions to Members of the Congress.
Thank you very much, Mr. Chairman.
Chairman Tom Davis. Any other statements? Mr. Bell.
Mr. Bell. Thank you, Mr. Chairman. I want to thank you and
the ranking member for focusing attention on what I think is a
very important issue, and I look forward to hearing the
testimony here today.
As the number of people accessing Internet pharmacy sites
has increased from 45 million in 1999 to an estimated 320
million by the year 2005, it is imperative that the Federal
Government lead the way to ensure that these sites are safe for
consumer use. While I don't completely disagree with my
colleague, Mr. Sanders, that I do think that consumers should
have access to affordable prescription drugs, we need to make
sure that it is safe.
Although law-abiding Internet pharmacies benefit modern
health care in numerous ways, some Internet pharmacies conduct
illegal and unsafe prescribing and dispensing practices that
can endanger the health of their patients. Because many online
pharmacies offer a variety of drugs, including controlled
substances, and do not adhere to ethical guidelines to protect
patients, the potential for harm to consumers is massive. These
pharmacies present a significant danger to health care
consumers and pose a regulatory nightmare that I'm sure we'll
hear more about today.
Mr. Chairman, I'm concerned that the Federal Government is
merely playing catch-up and stands to lose this race if we
don't take immediate action.
I thank you again for calling this hearing and I look
forward to working with the committee to find a plausible
solution.
Thank you, Mr. Chairman.
[The prepared statement of Hon. Chris Bell follows:]
[GRAPHIC] [TIFF OMITTED] 86641.010
Chairman Tom Davis. Thank you.
Mr. Ruppersberger.
Mr. Ruppersberger. Yes. Today we are going to discuss
online pharmacies. The cost of prescription drugs are on the
rise and everyone is looking to save money, and my concern
today though is for the consumer. I think there are certain
issues and questions that we need to discuss, and hopefully you
will discuss them in your testimony.
Are these sites secure? Are these sites protecting the
privacy of individuals who choose to purchase their
prescription drugs online? Are there verification systems in
place to make sure a prescription is legitimate and real? Are
the prescriptions that are sold valid, safe, and healthy?
I'm also concerned about these Web sites because I'm
concerned that the proper precautions and safeguards are not in
place to protect consumers.
While the growth of the Internet has allowed many Americans
to save money and experience real convenience, we have to
question the safety of these Web sites.
Thank you, Mr. Chairman.
[The prepared statement of Hon. C.A. Dutch Ruppersberger
follows:]
[GRAPHIC] [TIFF OMITTED] 86641.011
[GRAPHIC] [TIFF OMITTED] 86641.012
Chairman Tom Davis. Thank you very much.
Any other opening statements? Mr. Tierney.
Mr. Tierney. Thank you, Mr. Chairman.
I'd just ask for unanimous consent to enter my remarks in
the record and essentially adopt much of what Mr. Sanders said.
As much as we need to make sure that we have good regulatory
practices in place, we ought to be very careful to make sure
that we're not at the same time taking away from consumers and
people that need affordable prescription drugs and
alternatives. I would rather see us use this hearing as an
effort to make the system work so that they can, in fact, get
affordable prescription drugs, as opposed to one that's
shutting the door on them in that regard.
[The prepared statement of Hon. John F. Tierney follows:]
[GRAPHIC] [TIFF OMITTED] 86641.013
Chairman Tom Davis. Thank you.
Any other comments?
[No response.]
Chairman Tom Davis. If not, we're going to move to our
first panel of witnesses. We have Mr. William Hubbard here from
the FDA. Mr. Howard Beales will be testifying on behalf of the
Federal Trade Commission.
Mr. Taylor, you are accompanying him; is that correct?
Mr. Taylor. Yes.
Chairman Tom Davis. So you may be testifying. Why don't we
all rise? It is the policy of the committee to swear in
witnesses.
[Witnesses sworn.]
Chairman Tom Davis. Thank you very much.
We have a timer in front of you. When it is green, you keep
going. When it is orange, you have a minute to sum up. When it
turns red, we would appreciate your summing up, because your
total statements will be in the record.
Let's start, Mr. Beales, with you, and then Mr. Hubbard. We
thank you very much for being with us. As you can see, there's
a lot of interest among Members on this subject.
STATEMENTS OF J. HOWARD BEALES, DIRECTOR OF THE BUREAU OF
CONSUMER PROTECTION, FEDERAL TRADE COMMISSION; AND WILLIAM
HUBBARD, SENIOR ASSOCIATE COMMISSIONER FOR POLICY PLANNING AND
LEGISLATION, FOOD AND DRUG ADMINISTRATION
Mr. Beales. Thank you, Mr. Chairman and members of the
committee. I am Howard Beales, the Director of the Federal
Trade Commission's Bureau of Consumer Protection. I'm pleased
to be here today to present the FTC's testimony and to work
with the committee on these important issues.
For many years the Commission has actively attacked false
and misleading health care advertising, no matter the medium.
In the last 5 years, alone, the Commission has brought 105
health and safety cases. In most of those cases, some part of
the marketing occurred online.
We have been particularly concerned about fraudulent claims
on the Internet. The Commission's ``Operation Cure All''
targets Web sites that deceptively promote products or services
that purportedly treat or cure serious and life-threatening
diseases. Since June 1999, the FTC has filed 18 ``Operation
Cure All'' cases and sent warning letters to hundreds of Web
sites.
Of course, success would not be possible without the
efforts of our many law enforcement partners, including the FDA
and several State attorneys general.
The sale of prescription drugs on the Internet raises
special law enforcement challenges. Prescription drugs
available online offer consumers convenience and value. Many
online pharmacies appear to operate the same way traditional
pharmacies do; however, as this committee well knows, the
practices of some online pharmacies that file prescriptions
without adequately reviewing a consumer's medical history or
dispense unapproved drugs from overseas have significant
potential to injure consumers.
Historically, the States have regulated the practice of
medicine and pharmacy. In the last few years, a number of
States have brought actions against online companies that
dispense prescription drugs without a valid prescription or
have initiated professional disciplinary actions.
On the Federal level, the FDA is the principal agency with
both scientific expertise and statutory authority to oversee
online prescription sales, including the authority to take
action against the dispensing of a prescription drug without a
valid prescription.
The Commission can assist these agencies by bringing cases
against Web sites that engage in false and deceptive practices.
For example, in one case the Commission charged an online
pharmacy with falsely representing that consumers received care
by a clinic with physicians and an onsite pharmacy. There were
no physicians, no onsite pharmacy.
Following the anthrax outbreak in 2001, the Commission
investigated the possible sale of counterfeit Cipro on the Web.
Working with FDA, our staff ordered product samples from both
foreign and domestic Web sites and had them tested. No
counterfeit Cipro was discovered and no actions were filed. We
provided information about the foreign Web sites to the FDA.
Prescribing and dispensing drugs online may be illegal, but
unless it is deceptive or unfair it falls outside of the FTC's
authority and expertise.
We will continue to work closely with the FDA and other
Federal and State agencies and assist them when we can. We will
also continue to monitor the Internet for deceptive and
misleading product claims and to bring cases when appropriate
under our jurisdiction.
Thank you for this opportunity to present the Commission's
views. I look forward to responding to your questions.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Mr. Beales follows:]
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Chairman Tom Davis. Mr. Hubbard, thank you for being with
us.
Mr. Hubbard. Thank you, Mr. Chairman.
As you said earlier, I am accompanied by John Taylor, our
Chief Enforcement Official at FDA. We have a written testimony.
I'll make just a few remarks, if I may.
One of the best things Congress ever did for consumers in
our view, Mr. Chairman, is to create a modern drug approval
system. Drugs are tested for safety and efficacy and
manufactured to exacting specifications overseen by the FDA.
American patients can be almost totally certain when they go to
a licensed pharmacy that they are getting a safe and effective
drug.
The emergence of these illegal Internet sites poses a
fundamental threat to that safety/assurance system. We note, of
course, that there are legitimate Internet sites that are
licensed by the States and can properly dispense drugs and, in
fact, provide a public service, but let me show you a site. I
believe the committee may have a printout of a site that we are
looking at. I've taken off the name of this site to perhaps
protect the guilty. But this site, as you can see from the
information--it's also on the poster over here--a consumer can
go on and fairly easily buy some relatively serious drugs. Some
of these drugs have serious side effects and need to be taken
under the guidance of a physician, and some are, in fact,
controlled substances. We believe this is a very fundamental
threat.
Now, the patient that buys these drugs on the Internet site
has no way of knowing what they are getting. This offers
particular drugs. If I order any of these drugs, I have no idea
that I'm going to get that drug or it is going to be the real
drug or it is going to be a safe and effective drug. In fact,
there are cases in which people have ordered drug A and gotten
drug B.
I'll last say that this site that I have given you we have
begun to look at. This site looks like an American doctor and
nurse or doctors or whatever. It looks very normal. When we
checked, this site is actually in Thailand, and the drugs that
are coming from this site are from some place we don't know,
but I doubt they are from the United States. These sites have
sprung up continuously in recent years and they challenge the
ability of State and Federal authorities to combat them.
Now, FDA and other agencies in the States have taken a
number of steps to fight these rogue sites. We have been
educating consumers. We have many brochures and information on
our Web site and other things to warn people about these. We
have partnership agreements with the State medical and pharmacy
regulators to jointly attack these sites in many cases. We and
the FTC, as Mr. Beales has said, have been working on a number
of cases. FDA has enforced dramatically in this area. We've had
over 300 cases of Internet sites since 2000, 150 arrests. We
have 100 current investigations. And just today, this morning
the State of Oklahoma is going to court to seek an injunction
against an Internet site with the support of the FDA. That
action is one that we are trying to do in concert with the
States, and we believe that together the Feds and the State can
have an impact here.
So with those brief remarks, Mr. Chairman, I will say thank
you and take questions.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Mr. Hubbard follows:]
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Chairman Tom Davis. I'm going to start the questioning with
Mrs. Miller. The gentlelady from Michigan is recognized.
Mrs. Miller. Thank you, Mr. Chairman.
I'm particularly interested in this issue, as we are
talking about these various Internet sites and the kinds of
problems that we are having. I live in Michigan, obviously a
border State to Canada, and our seniors--I'm not sure if they
are on the Internet. They just get on the bus and go across the
Bluewater Bridge or the Ambassador Bridge and they're
purchasing their drugs in Canada. You can't hardly blame them,
certainly.
It has been interesting for me to listen to your testimony
here today. I notice that you said that you send out initial
warning letters to some of the sites that are illegitimate or
what have you. It is my understanding that what is happening
with many of the seniors, whether they are purchasing these
drugs over the Internet or whether or not they're just
traveling there personally, they do have to have a script from
a Canadian doctor. My understanding is that they'll go there
with a script from an American doctor and then have to have it
re-scripted by Canadian doctors.
How are you interacting not only with the States but with
the Canadian Government? Are you having any success in writing
these letters? You just mentioned that you only had one lawsuit
and you had another this morning with Oklahoma. Are you having
good cooperation with the local law enforcement from the
States, as well as the Canadian Government, on weeding out some
of these illegalities that are happening?
Mr. Hubbard. I will take that as my question. I certainly
think we are having good success. As I said, we have agreements
with the States in which we are attempting to coordinate our
actions. In terms of Canada, we have been in regular contact
with Canadian regulatory officials and they recognize that
these sites are illegal and are working at their end of the
border on them.
As far as patients coming across from Canada, the American
citizens, we try to warn them and tell them that they're taking
risks in buying these drugs.
We do not, of course, prosecute or otherwise take action
against individual consumers who go to Canada to purchase
drugs.
Mrs. Miller. I mean, it is a huge cottage industry
immediately across the various bridges that I have talked about
in our State, and I'm not sure if these Canadian doctors are
licensed or what is happening, but that's what my seniors are
telling me--that they just take these scripts and they are re-
scripted over by the Canadian doctors and they come back with
their drugs.
Mr. Hubbard. Well, the Canadian officials tell us that the
Canadian regulatory officials who oversee the practice of
medicine in Canada are very concerned about Canadian physicians
co-signing these prescriptions, and they are trying to make
that point to their physicians that they should not be doing
that. They do not consider it a good practice of medicine.
Mrs. Miller. Thank you.
Chairman Tom Davis. Thank you very much.
The gentleman from Texas.
Mr. Bell. Thank you, Mr. Chairman.
Mr. Hubbard, I want to talk to you for a moment about the
definition of a valid prescription. The FDA allows States to
determine the definition for valid prescription, correct?
Mr. Hubbard. That's correct. The Federal law says that a
prescription drug must be dispensed pursuant to a valid
prescription, but it does not define that, so FDA relies on the
State definition of valid prescription.
Mr. Bell. Is that part of the problem?
Mr. Hubbard. It certainly has been said by many that is a
problem; that if the individual State does not have a
definition of valid prescription that covers these Internet
sites, then that is viewed as a weakness.
Let me ask Mr. Taylor to say more about that.
Mr. Taylor. Sure. I can expand upon that.
It poses two challenges, one in the context of our own
statute, which basically says that if a product is dispensed
and there isn't a valid prescription, the drug product is
misbranded. So if there isn't a clear definition on the State
level as to what constitutes a valid prescription in the
context of the Internet, it is difficult for us to make a
misbranding charge.
In the criminal context, the challenge comes because in
order to show intent to establish a criminal violation, it is
difficult to establish intent if, again, the standard as to
what constitutes a valid prescription is not clear.
So, to the extent we have had success in building criminal
cases, it is often in those States where there, indeed, is a
clear definition as to what constitutes a valid prescription in
the context of the Internet.
Mr. Bell. From a regulatory standpoint, isn't it somewhat
of a nightmare, because you could be looking at 50 different
definitions for valid prescription, couldn't you?
Mr. Taylor. Indeed. And when we started working on the
Internet in 1999, both on the State level and the Federal
level, our statutes really never contemplated the use of the
Internet, quite frankly, as a means of conveying drug products,
and so I think both on the State level and the Federal level we
have tried to apply our laws in a way that allows us to address
this problem.
But you are right: in the context of the States, you have
50 different definitions, and therefore when we are putting
together cases or when we are investigating sites we have to
factor that in as a part of our strategy, and so that does pose
a great challenge to us.
Mr. Bell. Would it be your recommendation to try to come up
with one definition?
Mr. Taylor. Well, I don't think the administration has a
position on that; however, as I said, it has been a
longstanding concern to us because our inability to build the
cases we would like in certain circumstances.
Mr. Bell. And, just so we'll have a better understanding of
what is going on out there, I assume there are some folks that
are operating in a legitimate fashion?
Mr. Taylor. Absolutely. Absolutely. And I think one of the
programs that we think is very positive is NABP's Verified
Internet Practice Pharmacy Site program [VIPPS]. We also think
that is an excellent program because it allows consumers to
look at the seal and realize that they are getting a drug that
is pursuant to a valid prescription under State law, and also
that they are getting a drug that is FDA approved. So yes,
there are definitely legitimate sites. The Internet definitely
provides great benefits, including anonymity, convenience to
those who are homebound, as well as cheaper prices in some
cases, but that's not the case across the board.
Mr. Bell. Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you very much.
Mr. Duncan.
Mr. Duncan. Thank you, Mr. Chairman, and thank you for
calling a hearing on this very important topic.
Mr. Hubbard, as Congresswoman Miller said, you can't blame
these people for trying to get lower prescription drug costs
almost any way that they can--going to other countries or over
the Internet or something. But I've read several times in the
Wall Street Journal over the last few years that it costs they
estimate an average of $650 million to $800 million and 10 to
12 years to get a drug approved by the FDA. And then I remember
reading also in the Wall Street Journal a few years ago about a
small company in Illinois that had a breast cancer detection
pad that they had sold many, many thousands in other countries
and they had gotten approved in every industrialized nation
within weeks or months, but they had been, I think, at that
point 9 years dealing with the FDA. They had several doctors
quoted in that article saying thousands of women have died
because the FDA had been so slow and bureaucratic.
What I'm wondering about is why does it take so much longer
to get drugs approved here than in any other industrialized
nation in the world, and what are you doing now or have you
done some things to try to bring down those costs and those
time constraints to help, because that would do more than
anything to bring down the prices of prescription drugs in this
country.
Mr. Hubbard. Mr. Duncan, in fact, in the 1970's and 1980's
drugs did occasionally reach the U.S. patients last in some
cases because of--allegedly because of FDA requirements.
However, I would say that Congress stepped in on this issue
about a decade ago----
Mr. Duncan. Right.
Mr. Hubbard [continuing]. And created new legislation that
has resulted in drugs now being approved as fast or faster in
the United States than anywhere in the world, so our patients
do get the drugs faster than anywhere else.
It's very expensive to----
Mr. Duncan. I was here when we passed that legislation and
I remember that, and we did try to step in. But I still read
these articles in the Wall Street Journal and other places that
says FDA still--that the big drug giants can get things
approved real quickly, but some of these small companies don't
have a chance.
Mr. Hubbard. Well, when Congress passed that legislation it
gave us very strict review times, and we'd be glad to share the
data with you. We, in fact, meet those review times as directed
by Congress.
Mr. Duncan. So you are saying that we are now faster than
most other industrialized nations?
Mr. Hubbard. Than all other industrialized nations.
Mr. Duncan. All right.
Mr. Beales, how many people are buying drugs over the
Internet, as best as you can tell? And has the FTC--have you
received complaints about these drugs being fake in some way,
or can you tell us, do you know of anybody that has been hurt
by any of these drugs? I'm wondering about the scope of the
problem here.
Mr. Beales. We don't have a specific estimate of how many
people purchase drugs over the Internet. I mean, there are an
enormous number of people who make various health-related
purchases over the Internet, but I can't narrow that down to
pharmaceutical products.
We do get complaints about products that are ineffective.
They are--those don't tend to be complaints about prescription
drugs, but what most of the complaints we get from online
pharmacies--that concern online pharmacies are non-delivery
kinds of complaints and those kinds of issues.
We don't know of particular instances of cases where
somebody has tried to buy a drug that turned out not to work or
to be the wrong thing. That is what we were concerned about in
looking at Cipro, and we have in the past brought cases against
home test kids for AIDS that were sold online and, in fact, did
not work. So we know that problem is out there, but we don't
know of specific instances in prescription drugs.
Mr. Duncan. All right. Thank you very much.
Chairman Tom Davis. Thank you very much.
Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Beales, one possible model of addressing the Internet
pharmacy issue could involve shared response authority, shared
authority between FDA and the States. Shared enforcement
already exists within FTC law in the Telemarketing Act. Can you
explain how the Federal Government and States share enforcement
of the Telemarketing Act? And does this work in the case of
telemarketing?
Mr. Beales. Certainly. The way the Telemarketing Sales Act
is set up is the FTC writes rules that govern telemarketing to
define deceptive and abusive practices and specify
requirements, and then the FTC can enforce those rules, but
States also have the ability to go into Federal court to
enforce the Federal rule. There is a right of first refusal, if
you will. States have to tell us to go to Federal court, and if
we want to take over the case we can.
What that structure does is to preserve a uniform Federal
set of rules and Federal authority over what the rules will be
and remain, but it allows for individual States to go into
Federal court to obtain a national injunction to stop a
particular practice.
By and large, that scheme has worked well. We find that
mostly States prefer still to go into State court under their
own State laws, but there have been about 50 or so cases where
States have gone to Federal court in order to stop particular
telemarketing practices.
Mr. Waxman. Thank you. You testified that FTC has noticed a
large number of false or misleading claims made about dietary
supplements. After the death of Oriole's pitcher Steve Bechler
several weeks ago, a great deal of attention is focused on
ephedra products. Can you give us examples of statements made
by Web sites about ephedra that FTC considers false or
misleading? And let me also ask: if a company asserts that an
ephedra product is safe, is that considered misleading by the
FTC?
Mr. Beales. We have, in four cases so far, going back to
1997, challenged claims that ephedra was safe or had no side
effects as unsubstantiated. We don't think there is sufficient
scientific evidence to establish safety or to establish the
lack of side effects. And we have been successful in those four
cases that we have brought. We have other investigations
involving ephedra products, and there will be more cases that
are in the pipeline.
Mr. Waxman. Well, if a company asserts that an ephedra
product is safe, is that considered misleading by the FTC?
Mr. Beales. Yes, it is. We think that a claim is misleading
if it is false or it is misleading if there is not sufficient
scientific evidence to substantiate the claim, and in either
case we can and do go to Federal court in order to stop it.
Mr. Waxman. Mr. Taylor, some have suggested that there
should be a single Federal standard for what is valid
prescribing over the Internet. With a clear Federal standard,
would enforcement be easier?
Mr. Taylor. Indeed, it would, simply because, instead of
dealing with the standards of 50 States in terms of looking at
whether to bring a civil or criminal case, we would be dealing
with one unified standard for what constituted a valid
prescription.
Mr. Waxman. Thank you.
Thank you, Mr. Chairman. I yield back.
Chairman Tom Davis. Thank you very much.
Mr. Janklow.
Mr. Janklow. Thank you very much, Mr. Chairman.
Mr. Taylor, if I could ask you, give us an example of two
States that have different laws that define a prescription.
Mr. Taylor. You mean specific States or specific fact
patterns?
Mr. Janklow. Either one, because I just need an example of
two States that have a definition of ``prescription'' that's
different.
Mr. Taylor. Sure. There are some States that specifically
address, for example--if you notice up on the easel there is
essentially what is called an ``online questionnaire.'' There
are some States that specifically state that an online
questionnaire, filling out that online questionnaire does not
fall within the standard for the practice of medicine and does
not fall under the standard of what constitutes a practice of
pharmacy and therefore a valid prescription. There are other
States, however, that don't address the question of whether or
not an online questionnaire falls inside or outside the proper
standard of medical care or inside or outside the standard for
the practice of pharmacy or what constitutes a valid
prescription. That's two concrete examples of how an online
questionnaire is dealt with different in two different States.
Mr. Janklow. But, sir, your second example that you gave,
you said they don't say one way or the other, so I don't know
how that is a different example. One State may say that an
online fill-out is not a prescription, the other State is
silent. That doesn't mean it is.
Mr. Taylor. Well, actually, here's the difference. The
difference, in the context of a criminal case, is that if you
are going to bring a criminal case and you are going to go to a
U.S. Attorney's office, and as part of a statute in a criminal
case you need to establish intent, you're able to go to the
U.S. Attorney and say definitively that this type of conduct
falls outside what constituted a valid prescription, and by
this kind of conduct, the filling out of a questionnaire falls
clearly outside of what constituted a valid prescription within
that State, and therefore it is easier to establish that
someone has intentionally violated State and thereby Federal
law.
In the context of a State where it is unclear whether it
does or does not constitute a valid prescription, it is
difficult to show that someone, you know, willfully intended to
violate the law because they may not know, themselves, that----
Mr. Janklow. But, sir, as a practical matter, you can file
charges against somebody that should be determined. I mean,
what we're doing is making subjective judgments on cases that
we don't file, as opposed to filing an action where we believe
there is a violation and letting it be determined by judges
through the appellate chain.
Mr. Taylor. Well, in some cases where there is ambiguity
we've gone to the States to get an advisory opinion as to
whether or not the online questionnaire falls under a valid
prescription of medicine, but we have not, quite frankly----
Mr. Janklow. Let me ask you, if I can, this, sir.
Mr. Taylor. OK.
Mr. Janklow. Do you know of any State that says an online
questionnaire fulfills a prescription requirement?
Mr. Taylor. Not off the top of my head, but that doesn't
mean----
Mr. Janklow. OK. Mr. Hubbard, if I can ask you, you talked
about this case in Arizona [sic] that is being filed today. How
long has that case been being worked?
Mr. Hubbard. I don't know how long Oklahoma--it's Oklahoma.
I don't know how long Oklahoma has been working it, but we
spent a few, the last few weeks on it.
Mr. Janklow. Pardon?
Mr. Hubbard. We've spent the last few weeks on it. We are
reacting to the claims they are making to their Web site and to
the actual sales that they are making.
Mr. Janklow. And are there thousands of these sites out
there?
Mr. Hubbard. There are certainly hundreds. We have learned
that in many cases a given Web site is part of a larger
business that runs several Web sites, so it could be if you see
Web site A, there is also B, C, D, E all run by the same
company with different looks on the Internet.
Mr. Janklow. Do you have any estimate as to the number of
cases globally that have been filed in America, what percent
are civil, what percent are criminal?
Mr. Hubbard. As I said in my testimony, we have done over
300 at FDA. The States have done some number more, but I do not
have that number. Perhaps the next panel will know more.
Mr. Janklow. Are you aware of many instances where someone
has been shut down civilly where they have reopened under
another name or another operation?
Mr. Hubbard. Absolutely.
Mr. Janklow. So the civil law really doesn't work very
well, does it?
Mr. Hubbard. Well, I think that could also be true of the
criminal. If you don't catch the criminal and he has moved on
to another State or another country, just because you have
targeted them doesn't mean you have successfully put them out--
--
Mr. Janklow. I understand that, but, I mean, as a practical
matter there is less likelihood someone will be dealing with
the criminal law violations as a matter of choice than civil
law violations.
Mr. Hubbard. Let me ask John to answer that.
Mr. Taylor. Not in all cases.
Mr. Janklow. I said as a practical matter. I didn't say in
all cases.
Mr. Taylor. Not even in--I can't even say it is a practical
matter, because there might be some instances where a Web site
is disseminating a product that is so dangerous that it is,
quite frankly, more advantageous to try and move with the civil
case--for example, an injunction or seizure--that removes the
product from the marketplace quickly. Some of our criminal
cases are so complex that, quite frankly, it takes a certain
amount of time to put them together, and during that time in
some cases products could still be--the pharmacy could still be
dispensing products to consumers. So it really is a fact-based
analysis.
If you may, I just want to expound upon what Oklahoma is
doing today. One of the unique facets of the Oklahoma action is
this involves a storefront pharmacy which is accepting
prescriptions, sending the prescriptions to Canada, and then
obviously products are then distributed to consumers.
The reason why this particular storefront was of interest
both to the State of Arkansas and the State of Oklahoma is
because, as Mr. Hubbard said, the company was making misleading
claims about the FDA-approved status of their products, which
raises safety concerns that are troubling to us.
Part of, I think, the driving force for trying to address
this problem is to ensure that the American public has products
that, indeed, are FDA approved and that, indeed, are safe and
effective, and that's one of the reasons why the State of
Oklahoma moved the case.
Mr. Janklow. My time is expired. Thank you.
Chairman Tom Davis. Thank you very much.
Mr. Ruppersberger, and then Ms. Watson.
Mr. Ruppersberger. First, after listening to a lot of the
testimony and questions, it seems to me that clearly the
problem isn't getting any better and there's a lot of ambiguity
within different States and that we really do need to establish
some Federal standard. Would you agree with that premise?
Mr. Hubbard. Well, certainly we're getting that advice from
several points. Understand that there are significant policy
decisions around doing that because FDA does not regulate the
practice of pharmacy or the practice of medicine.
Mr. Ruppersberger. What policy decisions? If you were
sitting here, what would you suggest that we do to resolve and
try to help this situation?
Mr. Hubbard. Obviously, the advice you will get is that
there be a national Federal standard for a valid prescription,
but, as I was saying, there is a certain States rights issue
and federalism issue around whether you want to empower the
Federal Government to define what States traditionally have
done. Obviously, that's Congress' choice to make, not FDA's.
Mr. Ruppersberger. But isn't it true that State boards of
medicine, State boards of pharmacy, States Attorneys General
are all asking for this type of legislation?
Mr. Hubbard. And from their points of view it is a very
legitimate request.
Mr. Ruppersberger. And, you know, the issue is a Federal
issue. I mean, it's Internet, it's not within State.
Let me ask you this. I think, Mr. Taylor, you referred to
VIPPS. It is my understanding that VIPPS is a voluntary program
that certifies Web sites; is that correct?
Mr. Taylor. That's correct.
Mr. Ruppersberger. Well, it seems to me that's a very
simple issue, a very simple program. What would you think of
making VIPPS mandatory? What would be the down side of making
VIPPS mandatory?
Mr. Taylor. The administration does not have a position;
however----
Mr. Ruppersberger. Do you have a position?
Mr. Taylor. I don't have a position, either.
Mr. Ruppersberger. As an enforcer.
Mr. Taylor. However, obviously I think one of the reasons
why VIPPS is so good and one of the reasons why the agency
embraces it and tries to spread the word is because it does
provide consumers with good advice about the products that they
are seeking and it allows consumers to discern whether or not
they should be choosing from a site with the VIPPS seal versus
all the other sites that are proliferating out there on the
Internet.
Mr. Ruppersberger. Do we really think that by answering a
few questions a physician is in a position to prescribe
medicine?
Mr. Taylor. Well, I think the American Medical Association
has said that it is important to have a real doctor/patient
interaction, and that merely asking and having a few questions
answered does not fall within what they believe to be the
proper standard.
Mr. Ruppersberger. And what kind of actions do we have that
we can take against medical professionals that blindly
prescribe drugs?
Mr. Taylor. Well, on the State level there have been
instances where we have worked with medical boards who have
taken actions to disqualify a doctor based on their
interactions with a patient. We have, quite frankly--we had one
criminal case that we brought against a doctor who was not only
prescribing but also owned an Internet site and was
disseminating prescription--excuse me, disseminating drugs
without a valid prescription. So there are some actions that
can be taken on both the State and Federal level. But the
practice of medicine, as Mr. Hubbard said, does rest primarily
with the States.
Mr. Ruppersberger. Well, from sitting here and listening to
the testimony, it seems to me that a very practical solution
might be to encourage that VIPPs be changed to some type of
mandatory certification. That might be the first step for
getting the camel's nose under the tent. So I would hope that
you would take that back to your policymakers in the
administration.
Mr. Taylor. Fair enough.
Chairman Tom Davis. Thank you very much.
Mr. Turner, any questions?
Mr. Turner. Thank you, Mr. Chairman.
Mr. Taylor, I was fascinated by one comment you made. You
said that if they violated State law they thereby violated
Federal law with respect to the issuance of a prescription. In
your discussions from the whole panel on the issues of foreign
Web sites where people are logging on and buying prescriptions
and may not even know where they are buying them from, is there
any State that doesn't require that a valid prescription be
issued by a U.S.A. or State-licensed doctor?
Mr. Taylor. Yes. All the States require a valid
prescription. The key is--well, there are two keys. One is that
what constituted a valid prescription is not necessarily
consistent from State to State.
Mr. Turner. That's why I ask you is there a State that
doesn't require that a prescription be written by a licensed
doctor?
Mr. Taylor. Not that I know of. No, sir.
Mr. Turner. So these sites that are foreign or where there
doesn't appear to be any regulation that's going on, it would
seem that you would not have to wonder whether or not Federal
law is being violated and whether or not it satisfies all 50
States' regulations if you can determine or ascertain that a
U.S.A.-licensed medical doctor is not participating in the
transaction.
Mr. Taylor. That's correct.
Mr. Hubbard. And can I say, Mr. Turner, that for the
foreign sites it is almost irrelevant whether it's a valid
prescription because the drugs, themselves, are unapproved and
shouldn't be imported into this country.
Mr. Turner. And to what extent, then are you taking action
on those that are just foreign?
Mr. Taylor. Well, in the context, just using Canada as an
example, we have shared with the Canadian Government recently
45 Web sites that came to our attention, based on our own
domestic work, and we have asked for them to evaluate those Web
sites and to let us know whether or not they can take action on
their side of the border.
In the context of the action that Mr. Hubbard just talked
about, which involves Rx Depot, which is an action that was
brought not only by the State of Arkansas but also by the State
of Oklahoma, the Canadian--the province Manitoba has issued a
statement saying that they were going to take steps to notify
Rx Depot that the importation of products from Canada were not
only not in compliance with U.S. law, but was not in compliance
with the law in the province of Manitoba.
So, to make a long story short, what we try to do is
increase our contact with foreign governments and working
closely with them. Obviously, it poses a number of challenges,
one being products can appear to come from Canada but in some
cases they do not. And so one challenge is trying to figure out
exactly where the products come from.
The other challenge is, quite frankly, the fact that
different foreign governments, as well as the United States,
are becoming acquainted with this problem and we're all at
different places in terms of coming up with tools that can best
address what is now a global issue, as opposed to an issue that
is impacting specific countries.
Mr. Turner. Turning to domestic sites, then, to what extent
do you work to verify that a licensed doctor is participating?
You have the issue in all 50 States to what extent the
questionnaire is enough or not enough, but are you verifying
whether or not, as they state, that there is a doctor at all
involved in the transaction?
Mr. Taylor. Yes, we do. As a matter of fact, when the
Internet first--in 1999 and 2000 when the Internet first became
a very popular medium for the dissemination of these products,
there was a perception that most of these sites did not have
any doctor involvement.
What we found subsequent to that was that there are some
where there indeed is no physician involved; however, there are
others that do have physicians involved. And then the question
becomes whether or not the physicians, based on online
questionnaire or based on the interaction, are really
interacting with the patient in a way that again is consistent
with the standard for medical care and is consistent with what,
indeed, is a standard for a valid prescription. So yes, we do
try and determine that as a part of our investigations, because
that is going to be an important fact in determining not only
what charges apply but what remedies we want to use in order to
deal with the conduct if it is violative.
Mr. Turner. Thank you.
Chairman Tom Davis. Thank you very much.
Ms. Watson.
Ms. Watson. Thank you so very much, Mr. Chairman, for
holding this hearing.
I have been following this issue for many, many years. I
was chair of the California Senate's Health and Human Services
Committee. There are a couple of things that I want to address,
I guess to Mr. Hubbard and then to you, Mr. Taylor.
First, dealing with the foreign Web sites and the
prescriptive drugs that can be available, I have tremendous
concerns because the ingredients in a particular product vary
from country to country, No. 1. So many of these prescriptions
might be counter-indicative, depending on the ethnic group that
is using them, and so there is a tremendous danger.
I'd like you to comment first, Mr. Hubbard, on what you are
doing to look at the prescriptive drugs that can be ordered
without a doctor's assistance or without a doctor being in
relationship with the patient.
Mr. Taylor, could we have a national standard that says any
kind of prescriptive drugs that are ordered off the Internet
dealing with foreign pharmaceutical groups will be prohibited
if there is not a doctor related? Can we do that as a national
standard?
Mr. Hubbard, and then you think about your response.
Mr. Hubbard. To answer the question to me, you are
absolutely right that there is a great risk that drugs
purchased over the Internet from foreign countries could have
variability in ingredients and content, they can be
contaminated, they might not even be the drug you think you're
getting, so that is a very serious issue and we have been
trying to essentially stop those drugs from coming in by taking
some enforcement action, by asking foreign governments from
where those drugs are coming to step in, and by warning our
consumers who buy those drugs that they are taking great risk.
I'll let Mr. Taylor answer the other question.
Ms. Watson. Could we have a Federal standard as it
addresses the foreign pharmaceuticals?
Mr. Taylor. Again, the administration doesn't have a
position on a Federal standard; however, to the extent that
there were going to be policy discussions on the issue, I think
it would certainly be wise to try and, with whatever standard,
whether it be a Federal or State standard, try to come up with
a standard that addresses the myriad of fact patterns that
we're seeing in relation to these Internet sites, including the
one maybe that you just posed as part of your hypothetical.
Ms. Watson. Well, I understand that FDA has intervened when
there is no doctor or prescription involved at all, and in
terms of trying to set a national standard, as has been
mentioned here before, could we not start there with the
foreign pharmaceuticals? Would that not make sense?
I know each State has a board and they set their own
standards for practice, but this seems to be--since we are
dealing with the Internet, international, wouldn't it be in the
best interest of our Federal authority to prohibit the ordering
of a prescriptive drug if there has been no patient/doctor
contact?
Mr. Taylor. In the context of the foreign sites, quite
frankly, as Mr. Hubbard alluded to earlier, the issue of valid
prescriptions is just really one piece of the puzzle. I mean,
in regards to the foreign sites, there certainly are steps that
the agency could take to not only address the patient/physician
interaction, but, quite frankly, could take to address the
actual products, themselves, that are being sold on these
sites.
I mean, one of the over-arching concerns that the agency
has once again is that, you know, we certainly are cognizant
and sensitive to the fact that people are purchasing products
from these sites because of their cost, but the over-arching
concern that we have is that we, quite frankly, don't know a
lot about the manufacturer of these drugs, we don't know a lot
about the storage condition of these drugs, we don't know
whether these drugs are counterfeit. We don't know, quite
frankly, as to whether or not these drugs are originating in
Canada or have been trans-shipped from other countries. We have
had recent evidence that there are Web sites where the product
reports it came from Canada but, indeed, comes from----
Ms. Watson. Would you yield, Mr. Taylor?
Mr. Taylor. Yes. Sure.
Ms. Watson. To cut to the chase, couldn't we start there?
Since you have all these questions----
Mr. Taylor. Sure.
Ms. Watson [continuing]. And we are looking for a national
standard, would that not be the place to begin in terms of a
national, all 50 States?
Mr. Taylor. It is certainly----
Ms. Watson. Since we have all these questions.
Mr. Taylor. It is certainly something I am willing to take
back.
Ms. Watson. OK. Thank you.
Mr. Burton [assuming Chair]. The gentlelady's time has
expired.
Mr. Janklow.
Mr. Janklow. Thank you very much, Mr. Chairman.
Mr. Taylor, when the gentleman from Maryland asked you the
question ``what's the down side if we had a, so to speak,
national registry, if we required them to be registered,'' you
said the administration didn't have a position and you didn't
have a position. Do you know of a down side if we had a--I
don't care about a position. Do you know of a down side if
there were a national registration requirement?
Mr. Taylor. Well, I mean, I guess one down side would be
that on some level it takes away from the States the discretion
to pick the standard that they feel is best within their State.
Mr. Janklow. OK. Anything else that you know of for a down
side?
Mr. Taylor. Not off the top of my head. I don't know if Mr.
Hubbard has any----
Mr. Janklow. Mr. Hubbard, do you know of a down side, sir?
Mr. Hubbard. I will simply say that the way the Federal/
State relationships have evolved for 200 years in this country
is that the practice of medicine and practice of pharmacy are
inherently State responsibilities, and FDA is not being granted
the authority to regulate the practice of medicine except in
one limited area called a mammography program, so it would be,
to some extent, saying to FDA, ``You now have a more
substantial role in regulating the practice of medicine.''
Mr. Janklow. Sir, let's pursue that if we can for a second.
We have an FDA, don't we, and it is national?
Mr. Hubbard. Right.
Mr. Janklow. And the FDA, part of its national
responsibility is to be concerned about the quality of the
drug, of prescription drugs?
Mr. Hubbard. Right.
Mr. Janklow. And part of it has to be concerned with the
efficacy of what people may take those drugs for. That's also a
concern, isn't it?
Mr. Hubbard. Right, but the decision to give the drug to
the patient is a physician's decision, so he is really the one
deciding that this drug will work in this patient.
Mr. Janklow. But the FDA has a legitimate concern. I assume
you have a concern and you have exercised it with respect to
the fact that where a physician isn't in the loop, people
having access to drugs which you approve?
Mr. Hubbard. Well, if there is no physician at all, that is
clearly a violation of our act.
Mr. Janklow. OK. Well, it appears we have several kinds of
problems with the Internet, and I think--at least myself, I
have been mixing them. One, we have a foreign problem with
importation into this country. Two, we have a problem with
respect to the ability for myself to order drugs over the
Internet without going through a physician. And, three, we have
a problem of me being able to order over the Internet where I
have--where there is some physician in some other State that is
approving it. At least the fourth one is I have a valid
prescription, I feel I can get it cheaper some place other than
locally, and so I am ordering it over the Internet with a valid
prescription.
Can we agree we've got four different scenarios? Do you
know of any others that we're concerned with?
Mr. Hubbard. I think those are reasonable, although, as I
said, if there is no physician at all both the States and the
FDA can very clearly act in that circumstance.
Mr. Janklow. No, no. My question is: do you know of any
other scenarios other than the ones I've put forth? In my
questions, I'd like to deal with scenarios separately because
we intermingle them.
Mr. Hubbard. Sure.
Mr. Janklow. Do you know of any others?
Mr. Hubbard. None come to mind, but there may be some more.
But I think you have summarized well some of the dilemmas.
Mr. Janklow. OK. Sir, now eliminating the foreign issue and
eliminating the one where I've got a valid prescription from a
doctor in my State and I'm shopping for the best price, be it
in Canada or some other State, and I'm filling out a
questionnaire that is read by a doctor--that I send it from
here, this community, and it is read, it is seen by a doctor in
some other State, and on the basis of that I am sent a
prescriptive drug, do you know of any place in America where
that is the legitimate practice of medicine?
Mr. Hubbard. Certainly the medical practitioners have
advised us that they believe that is not legitimate practice of
medicine.
Mr. Janklow. OK. So you don't know of any place where it
is.
Do you, Mr. Taylor, know of any place where that is called
the legal practice of medicine?
Mr. Taylor. Sir, I can't think of a place off of the top of
my head. That doesn't mean that it doesn't--I just can't think
of a place.
Mr. Janklow. OK. So, with respect to that issue, that ought
to be something that the FDA could move forward on now, isn't
it?
Mr. Hubbard. Well, again, let's say you've got a patient in
North Dakota----
Mr. Janklow. A what, sir?
Mr. Hubbard. A patient.
Mr. Janklow. Sir, I'm hard of hearing. I wear a hearing
aid.
Mr. Hubbard. Let's say you have a patient in North Dakota
who goes on a Web site that is located in South Dakota.
Mr. Janklow. OK.
Mr. Hubbard. And the physician who writes that prescription
based on this sort of questionnaire is in South Dakota.
Mr. Janklow. Yes.
Mr. Hubbard. And North Dakota comes to FDA and says, ``Will
you go after this site?'' And we would ask the question of
North Dakota, ``Is that prescription that physician in South
Dakota is writing a valid prescription under your law?'' And if
they say, ``Well, our law doesn't deal with that. We don't have
an answer for you,'' then FDA is pretty much out of the game.
Mr. Janklow. Correct. Sir, do you know of any instance
where a State has ever done that, where they've said that a--
let's take your example--where a North Dakota, for example, has
said that a physician who is not licensed in the State of North
Dakota, has no nexus with the State of North Dakota, who fills
prescriptions for residents who are ordering them from North
Dakota based on some Internet document that's filled out, do
you know of any scenario where a State has ever said that's not
the practice--that's something that we don't have laws that
cover, or that it's not the practice--it is the practice of law
in our State?
[No response.]
Mr. Janklow. They don't.
Chairman Tom Davis [resuming Chair]. The gentleman's time
is expired, but we'll give him a chance to answer. Any
response?
Mr. Taylor. I believe initially in the State of Florida
there was, quite frankly, a situation similar to that. What the
State of Florida has done since then is it has actually tried
to come up with a stronger definition as to what constitutes a
valid prescription, but we did have some situations with the
State of Florida where there was some ambiguity as to whether
or not----
Mr. Hubbard. I believe the next panel will have more
information because they are the folks that are much more in
touch with that particular State issue.
Chairman Tom Davis. OK. Thank you. Thank you very much.
Mr. Lynch.
Mr. Lynch. Thank you, Mr. Chairman. I just want to thank
the witnesses for appearing here and helping the committee with
its work. I have a general question, and that is I know from
past experience in dealing with e-commerce, if you will, with
the European Union, that they had stricter guidelines with e-
commerce in Europe, not necessarily dealing with the United
States but internally. Are there any models out there to deal
with this problem from the European Community?
Mr. Taylor. Well, actually, I went to Geneva a couple of
years ago to meet with many of the European regulators.
Interestingly enough, there really isn't a good model because
in some respects the practice of Internet pharmacies is--their
practice is lagging behind ours, and so they are wrestling with
some of the same issues that we are wrestling with. I know that
there are some countries, particularly Germany, that are taking
a very aggressive stance, but, like the United States, there is
sort of a patchwork of approaches based on the fact that this,
too, is a new arena for them.
Mr. Lynch. OK. Thank you, Mr. Taylor. Thank you, Mr.
Chairman. Nothing further.
Chairman Tom Davis. I thank the gentleman.
Mr. Burton.
Mr. Burton. Mr. Hubbard, can a prescription written by a
U.S. physician be lawfully filled by a Canadian pharmacy?
Mr. Hubbard. As I understand it, the way Canadian law
works--and I am not an expert in that--is that there needs to
be a Canadian physician's signature on that prescription before
it is filled by a Canadian pharmacy, although I do understand
that sometimes they are co-signed. It will actually be the same
piece of paper, and then the Canadian physician will sign his
name to it, as well.
Mr. Burton. I think that is the practice. I think that when
a legitimate prescription from an American doctor goes up
there, they have it reviewed by a Canadian physician, and he
either writes a separate prescription that is identical or he
initials that in some way, so it is double checked.
How many times has there been drugs from Canada that have
come across the border and harmed American citizens, other than
it would harm an American citizen if it was even purchased here
in the States?
Mr. Hubbard. We have very little information of harm.
Mr. Burton. But to your knowledge how many times?
Mr. Hubbard. From Canada, I know of none.
Mr. Burton. We don't either, and we have been checking on
it.
GlaxoSmithKline has gone to the pharmacists up there who
sell over the Internet and they've said that if they continue
to sell into the United States that they're going to stop
giving them drugs from their company. Many of us believe they
are the stalking horse for a lot of pharmaceutical companies in
the United States who charge double, triple sometimes the
amount for drugs in the United States that they charge in
Canada. Now, you just talked about the European Union and
England. Isn't GlaxoSmithKline a European company?
Mr. Hubbard. Originally the parent company was originally
English, yes. I think their headquarters now for the domestic
operation is in North Carolina.
Mr. Burton. No, but they still are pretty much controlled
out of England, aren't they?
Mr. Hubbard. I don't really know their corporate structure
that well.
Mr. Burton. Well, we'll check that out when we have our
subcommittee hearing. But you don't know of any cases where the
pharmaceuticals coming from Canada have caused any unusual
problems?
Mr. Hubbard. Of course, there is no system to recognize
that. Those are not legal drugs, so therefore the medical
system doesn't track them.
Mr. Burton. Well, but an American doctor writes a
prescription. It's got to be double checked by a Canadian
doctor. Then they issue a prescription. It sounds like a pretty
good check and balance. The only difference to me, it sounds
like, is the cost is maybe double or triple down here.
Mr. Hubbard. Well, you'd certainly have a check in the
sense that it sounds like in that scenario you give the patient
has been adequately diagnosed by a physician and he's written a
prescription he believes to be appropriate.
Mr. Burton. Let me ask----
Mr. Hubbard. But we don't know what the actual drug is that
is being ordered.
Mr. Burton. You are inferring that the Canadians don't
police that and it might be an adulterated pharmaceutical
product?
Mr. Hubbard. The Canadians tell us that if the drug is
intended for the U.S. market they do not regulate that.
Mr. Burton. They don't regulate that, but they have a
doctor that double checks the prescription and has--but you
don't know of any adverse impact of pharmaceuticals from
Canada?
Mr. Hubbard. The Canadians inform us that a Canadian
physician should not be co-signing these prescriptions because
that physician has not seen the U.S. patient.
Mr. Burton. Yes. Let me ask you a question. If you take a
product that is sold here in the United States by
GlaxoSmithKline or any other pharmaceutical company and it
costs two to three times what it does in Canada or maybe any
other country in the world, what do you think about that?
Mr. Hubbard. I think, first of all, it's not that the drug
necessarily is priced higher here; it's priced lower in
countries that have price controls. That's the reason for the
price difference.
Mr. Burton. You're indicating then that they don't make a
profit on the pharmaceuticals they sell in Canada?
Mr. Hubbard. They may well, but that's not really FDA's
purview. Our concern is the safety of the drugs.
Mr. Burton. I know, but the point is that the
pharmaceutical companies and the FDA seem to be in lock step on
trying to control the flow of drugs out of Canada, and people
are saving a ton of money by buying their pharmaceuticals from
Canada. Over a million people do it right now, and there has
been no claim that there has been any problem.
It seems to me unbelievable, especially since we have
passed NAFTA and we are supposed to have free trade, as long as
those prescriptions are double checked the Americans ought to
benefit from the lower cost of those pharmaceuticals just like
the Canadians do.
Mr. Hubbard. Well, your argument is certainly one we hear a
lot, Mr. Burton.
Mr. Burton. But the pharmaceutical companies, who are
making a very, very large profit worldwide, are making a profit
in Canada, they are making a profit in other countries where
they're selling them at half the price they are here in the
United States, so what they are doing is they are loading the
price of U.S. pharmaceuticals so they can make a bigger profit.
You wouldn't agree with that though, would you?
Mr. Hubbard. Well, I don't think that's my job to agree or
disagree with that.
Mr. Burton. Your job is to make sure that they are of the
purity and that they are not going to harm American citizens.
Mr. Hubbard. That's correct.
Mr. Burton. What about a reciprocity agreement with the
Canadians? Would you----
Mr. Hubbard. Well, there are exemptions from the free trade
statutes, I understand, that allow each country to set its own
public health standards, and in this case drugs are approved
for safety and efficacy in the United States and there has not
been a program in place to approve drugs made in other
countries unless they are formally shipped in and----
Mr. Burton. Mr. Chairman, let me just make sure he answers
this question. Would it be a problem if there was reciprocity
between the United States and Canada?
Mr. Hubbard. Certainly there is a concept called
``equivalence'' that has been adopted by some agencies to say
that products from one country can more freely come in. That's
something we are looking at. But there is not currently a
reciprocity agreement in place with Canada on drugs.
Mr. Burton. Thank you.
Chairman Tom Davis. Thank you. I think the reality is in
most cases it doesn't take that much to make the pill; it is
the research and development that goes into it, and you make a
profit whether you sell it in Mexico, Canada, or the United
States. You make more, you know, greater areas. That's really
not your purview, though.
Mr. Hubbard. That's right.
Chairman Tom Davis. You are to make sure they are safe, and
you deal on that basis.
Mr. Hubbard. That's right.
Chairman Tom Davis. And you can understand the frustration
of a lot of Members when it looks like the United States is
paying more----
Mr. Hubbard. Yes.
Chairman Tom Davis [continuing]. Than consumers in other
places. And so this is all about safety, but I think it shows
us, as some of the opening statements from some of our other
Members indicated, the frustration of Americans who are paying
higher prices and in some cases finding it not affordable.
We appreciate your input in this.
We have another panel to get to. Mr. Sanders, I can
recognize you, but we want to get to the next panel.
Mr. Sanders. I missed Mr. Burton's comments, but I
understand that they were similar to some of my original
comments and I want to go on record in supporting him.
Mr. Hubbard, in terms of the regulatory system in Canada,
in your judgment is it inferior in protecting the Canadian
people than the system in the United States?
Mr. Hubbard. I certainly don't think that's my judgment to
make.
Mr. Sanders. But you told us earlier that you communicate
with Canadian authorities.
Mr. Hubbard. Right.
Mr. Sanders. I presume you communicate with your
counterparts in Canada.
Mr. Hubbard. That's correct.
Mr. Sanders. They have a system similar to the FDA. My
understanding is that it is as strong or stronger. Do you
disagree with that?
Mr. Hubbard. They tell us that they have a similar system
to ours. In terms of its resources, its people, it is less
robust than the FDA's system. They only have, for instance, 100
inspectors for their entire country.
Mr. Sanders. Yes, but their country is a lot smaller than
our country. Have you heard of problems in Canada where people
are becoming ill with adulterated medicine?
Mr. Hubbard. No. We don't have the evidence----
Mr. Sanders. This is something that I mentioned earlier
when I raised some questions, that you warn Americans about the
potential dangers of buying medicine in Canada. About a million
Americans, to the best of my knowledge, do buy medicine in
Canada. You warn them, but have any of them become sick?
Mr. Hubbard. No. Again, we don't have the evidence, but let
me point out that a big part of the concern is that even if the
Canadian drugs today are just fine--and, you know, we don't
know, but if this practice were legitimized, Canada could
become strictly a trans-shipment point for Third World
countries to send drugs to.
Mr. Sanders. Not if we develop laws, as we did. Mr. Janklow
made the point that there was reimportation legislation passed
several years ago in cooperation with the FDA which had very,
very strong safety elements. In fact, we spent too much money,
but I supported that. You're not suggesting for a moment that,
with the resources of the United States of America, we cannot
develop a safety mechanism with our Customs people, with the
FDA, to make sure that every medicine that came into this
country was absolutely safe?
Mr. Hubbard. Well, you'll recall that when that statute
passed that there was a provision for the Secretary of Health
and Human Services to certify that it could be safely
implemented. Secretary Donna Shalala refused to do that
certification and Secretary Thompson refused.
Mr. Sanders. Actually, I do know it because we wrote it. So
let's be clear about what happened with Secretary Shalala. What
happened in the process is at the very end in the Senate there
were loopholes put in. What that provision said is the
Secretary has got to say, as a result of that legislation, that
the American people would be paying lower prices and that the
safety element will be preserved. In fact, because of those
loopholes the Secretary could not appropriately enough say the
prices would be lower because what was in those loopholes is
what Glaxo is doing today. But the bottom line is you're not
going to suggest that, with the resources of this country, we
cannot develop a regulatory system to make sure that all
medicine coming in--we get beef from Canada, we get vegetables
from Mexico. How would we not be able to make sure that we
could protect Americans who buy prescription drugs?
Mr. Hubbard. We certainly could think of provisions that
would ameliorate the safety risks from foreign imported drugs.
We do not believe such provisions could be crafted in a way
that they would not lower the current safety standard, which is
very high in this country.
Mr. Sanders. In terms of safety, let me ask you this.
You're very concerned about safety. How many Americans are
dying in this country today because they can't afford a
medicine?
Mr. Hubbard. I have no idea.
Mr. Sanders. Do you think that's an important issue to
pursue?
Mr. Hubbard. Absolutely. My own 90-year-old mother cannot
afford her drugs, Mr. Sanders.
Mr. Sanders. For the record, Mr. Chairman--and I'll end,
and I thank you for allowing me to ask these questions--they
talk about safety, but he has just told us that not 1 American
out of 1 million, we think, has become sick by importing
medicine from Canada. He will not tell us how many thousands
may suffer because they cannot afford the medicine that their
doctors are prescribing. In my State doctors tell us, ``Why
waste our time writing out a prescription when a person can't
afford to fill it?''
I would like to see you do a study and tell us how many
people are dying in America because they can't afford medicine
and are getting sick, and that number will be 1,000 times
higher than anybody from Canada who is becoming ill.
Thank you very much, Mr. Chairman.
Chairman Tom Davis. Thank you. I don't think he was
prepared to answer those questions today, but the gentleman
wants to initiate a study and try to get that information, I
would be happy to--thank you all for being with us.
I'm going to ask just one question. I had one question I
wanted to ask. Mr. Hubbard, is it true that all enforcement
authority here today can take the same kind of action against
these illegal domestic Internet pharmacy sites under existing
law?
Mr. Hubbard. Can you repeat the question, sir, just to make
sure I get it?
Chairman Tom Davis. Can you take--the enforcement authority
you have today, can you take action against these illegal
domestic Internet pharmacy sites under existing law?
Mr. Taylor. We can take actions under existing law;
however, as I described earlier, there are challenges, and one
of the challenges is being able to use our full set of tools in
those instances where it is difficult to discern whether or
not--where it is difficult to discern what, indeed, is the
standard for a valid prescription in each State.
Chairman Tom Davis. Right. So additional tools would be
very helpful at this----
Mr. Taylor. Well, to the extent that, you know, there are
challenges posed by the fact that there, indeed, is a
difference in the standard of what constitutes a valid
prescription. I mean, we have--and let me be clear here. Under
the act there is a provision that allows us to make a
misbranding charge if there is--if the product is dispensed
without a valid prescription, so we have the tool, we have the
authority. It's just that in order to meet that definition
under the act we are dealing with standards that vary from
State to State. So, in terms of statutory tools and statutory
language, we have the ability to address these situations;
however, from a practical standpoint it is difficult to do so
because, indeed, there is a different definition as to what
constitutes the standard of prescription in each State.
Chairman Tom Davis. I've got you. All right. Thank you all.
Let me say to all of you thank you very much.
Anything else you wanted to add?
[No response.]
Chairman Tom Davis. Thank you very much for being with us.
We have our second panel today. We have Jim Thompson of the
Federation of State Medical Boards, Carmen Catizone of the
National Association of Boards of Pharmacy, and Connecticut
Attorney General Mr. Richard Blumenthal. We appreciate all of
you bearing with us through the first panel.
It's the policy of the committee we swear the witnesses in,
so, if you would, stand up with me and raise your right hand.
Do you solemnly swear that the testimony you are about to give
will be the truth, the whole truth, and nothing but the truth?
Mr. Thompson. I do.
Mr. Catizone. I do.
Mr. Blumenthal. I do.
Chairman Tom Davis. Thank you all very much. You may be
seated.
We'll have the timers in front of you--green, yellow with a
minute to go, and then red. Your entire statements are in the
record. Your questions will be based on this.
Dr. Thompson, why don't we start with you and end up with
General Blumenthal.
Thank you all for being with us.
STATEMENTS OF DR. JAMES THOMPSON, M.D., EXECUTIVE VICE
PRESIDENT, CHIEF EXECUTIVE OFFICER, FEDERATION OF STATE MEDICAL
BOARDS; CARMEN CATIZONE, EXECUTIVE DIRECTOR, NATIONAL
ASSOCIATION OF BOARDS OF PHARMACY; AND RICHARD BLUMENTHAL,
ATTORNEY GENERAL, STATE OF CONNECTICUT, ON BEHALF OF THE
NATIONAL ASSOCIATION OF ATTORNEYS GENERAL
Dr. Thompson. Good morning, Mr. Chairman and members of the
committee. I am Dr. Jim Thompson. I am executive vice president
and chief executive officer of the Federation of State Medical
Boards of the United States. I will refer to us as the
Federation.
The Federation is a national nonprofit association
established in 1912 which serves as a collective voice for 70
member State medical licensing and disciplinary boards. The
Federation's primary mission is to improve the quality, safety,
and integrity of health care by promoting high standards for
physician licensure and practice, as well as supporting and
assisting State medical boards in their protection of the
public.
The Federation has been recognized as a national leader on
the issue of telemedicine regulation and has published model
telemedicine license legislation and guidelines for Internet
prescribing and medical practice. In our guidelines, the
Federation recommends that Internet prescribing or practice be
based on--and I quote from that text--``a documented patient
evaluation including history and physical evaluation adequate
to establish diagnosis and identify underlying conditions and/
or contra-indications to the treatment recommended and
provided, and must be obtained prior to providing treatment,
including issuing prescriptions electronically or otherwise.''
The Federation's key concern with respect to Internet
pharmacies is that there must be an appropriate relationship
between the patient and the physician before a prescription is
written and dispensed. In addition to our guidelines, the
Federation has aggressively sought to identify Internet
pharmacies that dispense drugs based on prescriptions that do
not meet minimal standards.
In September 2000, the Federation of State Medical Boards
established the National Clearinghouse on Internet Prescribing.
This was designed to collect and disseminate information on
rogue Internet sites offering prescribing and dispensing
services for prescription drugs to consumers. A major goal of
the Clearinghouse is to facilitate communications among all
entities that play a role in regulating Internet pharmacy
operations and the physicians associated with them.
Regulatory efforts of State medical boards and other
agencies have been complicated by a number of factors,
including: one, the inability to identify the physical location
of the business or pharmacy; two, anonymous physicians
approving prescriptions; and, three, the lack of licensing
information on such physicians and the pharmacies.
In addition, because online pharmacies operate in multiple
States, lack of formal lines of communication has resulted in
the duplication of efforts and missed opportunities for
cooperation among regulatory jurisdictions.
The Federation strongly supports State-based regulation of
the practice of medicine. With regard to Internet prescribing,
State medical boards have the authority to discipline licensed
physicians prescribing and dispensing medications
inappropriately. Many boards have already taken actions against
licensees, adopted rules and policies, or introduced
legislation to clarify this authority. These efforts have been
effective in closing several Internet sites and causing a
number of physicians to cease their affiliation with
questionable operations.
The Federation believes that there are at least three areas
in which there is a need for Federal legislation to protect
patients ordering prescriptions over the Internet.
First, the patient should know with whom they are dealing.
They should know the name and location of the pharmacy that is
dispensing the drug, and they should know the name of the
physician who will be providing a medical consultation that
will be the basis of that prescription. This information should
be disclosed on the Internet pharmacy Web site.
Second, States are currently not able to enforce
injunctions against Internet pharmacies beyond their State
jurisdiction. Nationwide injunctive power would greatly enhance
enforcement capabilities and reduce the tremendous duplication
of efforts currently taking place.
Third, I noted in my testimony that State licensing boards
currently have the authority to discipline physicians who are
prescribing and dispensing drugs over the Internet
inappropriately.
Federal authorities have indicated the need for
clarification of certain issues, such as what constitutes an
appropriate physician/patient relationship, in order to
facilitate Federal enforcement actions. The Federation believes
that it is possible to define an appropriate physician/patient
relationship narrowly solely for the purpose of enforcing a
Federal law regulating Internet pharmacies without affecting
the autonomy of the State boards to regulate the practice of
medicine. We would be interested in pursuing this course of
action with this committee.
Thank you for the opportunity to testify today. I will be
glad to answer questions at the appropriate time.
I have attached to my testimony the Federation's model
guidelines for the appropriate use of the Internet in medical
practice.
Thank you.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Dr. Thompson follows:]
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Chairman Tom Davis. Dr. Catizone.
Mr. Catizone. Thank you, Mr. Chairman. I'd also like to
thank the Representative for his earlier comments on the VIPPS
program.
I am the executive director of the National Association of
Boards of Pharmacy [NABP], which was founded in 1904 and
represents all the pharmacy regulatory and licensing
jurisdictions in the United States, Puerto Rico, the Virgin
Islands, eight provinces of Canada, three Australian states,
New Zealand, and South Africa. Our purpose is to assist the
States in developing, implementing, and enforcing uniform
standards for the purpose of protecting the public health.
Internet pharmacies serving patients in the United States
provide valuable and innovative services to the patients. It is
unfortunate that the benefits of these legitimate pharmacies
are often overshadowed by the activities of rogue sites whose
concerns do not rest with the best interest of the patient or
compliance with State and Federal laws.
Over the past 6 years, NABP has assumed an active role in
differentiating legitimate pharmacy sites from rogue Internet
sites that illegally sell or distribute drugs. During that time
we've worked with the State Boards of Pharmacy and Medicine,
the FDA, and State legislatures to develop regulatory
strategies to manage this emerging area and provide consumers
with information needed to distinguish between legitimate
pharmacy, Internet sites, and rogue sites. Our efforts have
helped millions of consumers and resulted in the closing of
rogue sites and the prosecution of pharmacists and physicians
involved with those rogue sites.
In NABP's opinion the FDA has worked with the States not to
avoid taking action but to construct an effective enforcement
process that respects States' authority and affords due
process. Undoubtedly, the issue of importation of medications
from Canada is a complex issue. It is fueled by price
differences, but it is an issue that cannot be resolved by
allowing illegal activities to occur. Oversight on both the
State and Federal level is needed to bring the system into
compliance or to enforce the laws that presently exist.
Our research has found that rogue sites create several Web
pages around their primary operations. The objective of this
operation is to capture as many consumers as possible and
deceive them into believing that the Web pages are independent
operating sites and can deliver drugs.
The information posted on these rogue sites is often
purposefully misleading and in some cases purposely fraudulent
so as to lure consumers to these sites and engage them in the
illegal purchase and distribution of drugs.
The VIPPS program which was mentioned earlier combines
State regulation and licensure with consumer empowerment. NABP
conducts an intensive onsite review of all sites in adherence
to a 19-point criterion that looks at all standard licensure
requirements, as well as special Internet applications.
The VIPPS program was implemented with wide consumer
acceptance and support. Information about the VIPPS program has
appeared on national local news media and consumer information
specials. The exposure included programming on CNN, ABC World
News Tonight, NPR Radio, NBC News, CBS News, Fox News, and
other local media outlets. Articles, stories, and consumer
advice recommending the VIPPS programs have also appeared
throughout the print media in local newspapers across the
country as well as in Time Magazine, Newsweek, Ladies Home
Journal, Consumer Reports, USA Today, the Wall Street Journal,
the New York Times, the Washington Post, and other national
publications. NABP estimates that more than 10 million
consumers have heard, watched, or read about the VIPPS program.
The States have determined that Internet sites offering
prescription medications are engaged in the practice of
pharmacy and therefore must abide by the same laws and rules
that presently apply to traditional brick-and-mortar
pharmacies. Internet pharmacies, although unique in their
structure and environment, essentially represent the operations
of non-resident or mail order pharmacies.
Any Internet legislation that seeks to address consumer
need or consumer information should include verified
information. NABP applauds the objective to separate rogue from
legitimate pharmacy sites, but believes disclosure without some
outside, independent assessment or verification will only
deceive the consumers further. If this has not occurred, then
rogue sites will engage in illegal activities with a new
marketing tool--Government-mandated but unverified disclosures.
It is NABP's position that without this validation of
information, rogue sites will post fraudulent information to
mislead and confuse the public without any regard for the
possible penalties or actions for engaging in such conduct.
We appreciate the opportunity to be here today, and I will
be glad to answer any questions.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Mr. Catizone follows:]
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Chairman Tom Davis. General Blumenthal, thanks for being
with us.
Mr. Blumenthal. Thank you, Mr. Chairman, and thank you for
your leadership on this issue in holding a hearing and for the
very perceptive and insightful questions that have been asked
about this problem which surely requires Federal intervention
at this point to strengthen the role of State oversight, as
well as Federal scrutiny in an area that, unfortunately, is
rife with abuse, deception and health damage.
The Internet offers enormous promise, as I've indicated in
my testimony, for consumers to save very hard-earned dollars
and scarce dollars that they need to buy prescription drugs.
In a survey that my office will release just next week,
probably, we surveyed six Internet pharmacies and compared them
to bricks-and-mortar stores and found that consumers can
realize very, very significant savings, not just pennies or
dollars, but literally hundreds of dollars in using certified--
that is, VIPPS-approved--Web sites to buy drugs that they
purchase pursuant to valid prescriptions.
I think that the abuses here come when the Web sites are
used with questionnaires, without legitimate prescriptions,
without any prescriptions at all, without any diagnosis from a
licensed doctor, and that is where the remedies ought to come.
If I may outline some of the areas that I think are
particularly appropriate and important for this committee to
address, as Dr. Thompson has said, I would recommend that
Congress require all Internet Web sites to provide information
about the location of the pharmacy, the legal entity owning it,
a contact person for consumer complaints, a list of employees
and State licenses--in short, the kind of information that will
enable consumers and State enforcers, as well as Federal
regulators, to pinpoint responsibility and hold them
accountable.
I would disagree with the implication that there needs to
be a national standard for prescriptions. I think each of the
States now has such standards. I don't object as a matter of
principle to there being a national standard, but I think it
may divert energy and attention away from the areas that do
need fundamental reform.
For example, I think Congress ought to require all Internet
pharmacies to dispense pharmaceutical drugs only when the
prescription meets the standards of the State where the
resident who is buying the pharmaceutical drug actually lives.
Requiring them, for example, to meet Connecticut standards
would mean they need the address of the practitioner who is
prescribing the drug, the name of the drug, the dosage, the
strength--basic information that is contained in every
prescription in every State across the country.
And then also very importantly I think that Federal law
ought to require Internet pharmacies to require that
prescriptions be done by a health care provider who meets the
State licensing requirements. If I were to go to Indiana or
Virginia or South Dakota or New York and receive the
prescription from a licensed doctor, I wouldn't have questions
about the basic credentials and abilities of that doctor. The
point is to require a prescription that meets the State
standards from a practitioner who meets the State standards.
And let me just say that the issue here very often does
become one of enforcement, as Mr. Janklow implied. States need
the ability to go to a Federal court. We need Federal
jurisdiction for national injunctions, not just in the State
where we try to shut down one of these rogue Internet sites. In
Connecticut, for example, we did so against a number of the
sites and the physicians and we are still in court on issues of
jurisdiction, procedural kinds of tangents, because we are in
our State court rather than Federal court, and so we do need
Federal jurisdiction and the power to seek national
injunctions.
And, finally, we need tougher penalties so that the fines
and the monetary punishments are not just regarded as the cost
of doing business but offer a real sanction against some of
these online outlaws.
I think that these sites can offer real benefits for
consumers. The VIPPS program has been working very well. I
commend the NABP for its efforts in that regard. There is a
real potential here, as long as we avoid the possible abuses.
I might just close--and I thank you for giving me a couple
of extra moments--by making a suggestion about the foreign
jurisdictions. If there is a threat from Internet pharmacies
based in foreign countries, I might suggest that the Congress
could ban the use of any financial instruments such as checks,
money orders, and electronic transfers, in payment for those
kinds of prescriptions that come from foreign-based Web sites.
I realize they are tough to reach, even under the Federal
jurisdiction, but in cutting off the financial air supply, so
to speak, we can reach those kinds of foreign-based Web sites.
The analogy would be to Internet gambling, where a similar
suggestion has been made under Federal law to ban certain kinds
of Internet gambling from foreign-based Web sites. I think the
same kinds of remedies would be effective here. Thank you, Mr.
Chairman.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Mr. Blumenthal follows:]
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Chairman Tom Davis. We'll begin the questioning with Mr.
Burton.
Mr. Burton. I think everybody in the Congress and in the
country wants to make sure that the kinds of pharmaceuticals
that are being consumed by Americans are safe. We all want
that. We don't want adulterated pharmaceuticals. But at the
same time, we have millions of Americans who can't afford to
pay the prices for some of these pharmaceuticals here in the
United States, and yet they can afford the pharmaceuticals that
are the same from Canada. We've already heard that there are no
known cases of pharmaceuticals damaging Americans from Canada
where a prescription has been filled up there.
So my feeling is--and I'd like to ask all of you this
question--what would be wrong if we had some kind of a
reciprocity agreement between States and between countries
where they could check and make sure that these online
pharmaceutical distributors comply with the laws of, say,
Canada as well as the United States, or Iowa as well as
Indiana? It seems to me that we ought to be bending over
backward not only to make sure things are safe, but to make
sure that our citizens are not discriminated against by
pharmaceutical companies.
I mean, when you have a product that costs one-third more
in the United States than it does in Canada and you know that
the pharmaceutical company that is selling that product in
Canada is making a very good profit up there, then you know
they're making an absolute killing on that product down here in
the United States. And you can't say that the Americans should
bear the brunt of that.
I have friends of mine that were paying over $1,000 a month
for very significant kinds of drugs because they had not only
high blood pressure but diabetes and a whole host of things,
and in Canada they are getting them for about a third or half
of that. Now, why should they have to pay double what they
would pay in Canada? And if you have an agreement, a
reciprocity agreement between the countries that the two
governments could agree on, it seems to me that would be a
legitimate thing for Americans to expect.
Do any of you have a comment on that?
Mr. Catizone. I have a comment on that also. We have one
documented incident of a patient in the United States being
injured by a medication from Canada. Action is being filed in
the State of Oregon. A patient being treated for breast cancer
received the wrong medication and for 3 months was taking that
medication, and unfortunately that patient is not doing well
now. She has hired an attorney. The attorney has filed an
action and also reported it to the State Board of Pharmacy in
Oregon----
Mr. Burton. OK.
Mr. Catizone [continuing]. As well as with authorities in
British Columbia.
Mr. Burton. So there is one case that you know of?
Mr. Catizone. Right. The position that we have taken,
Representative----
Mr. Burton. Well, let me just interrupt. I'm sorry. There
is one case that you know of?
Mr. Catizone. Yes, sir.
Mr. Burton. Are there any other cases that you know of?
Mr. Catizone. We've just begun tracking that information.
Mr. Burton. But you only know of the one right now?
Mr. Catizone. Yes, sir.
Mr. Burton. How many cases in the United States where
doctors have prescribed medicine and people were injured from
the medication that they received here in the States?
Mr. Catizone. Estimates run anywhere from 1 to 10 percent
of all patients treated have some----
Mr. Burton. That's 1 to 10 percent of all patients?
Mr. Catizone. Yes.
Mr. Burton. So you're telling me there is one patient in
Oregon that was damaged by a pharmaceutical product coming out
of Canada, but you say 1 to 10 percent of the people are
damaged here in the United States?
Mr. Catizone. Yes, sir.
Mr. Burton. So it is really not a big difference. In fact,
unless you find something else, the percentage is probably
lower coming in from Canada, unless you find other things.
Mr. Catizone. We've just begun looking at it. Until we----
Mr. Burton. I understand, but yes, see the point I'm trying
to make----
Mr. Catizone. And the point we'd like to make is our
position has been very clear. We believe either the laws should
be enforced that currently exist or, as you have suggested,
there should be mutual recognition of products approved by
Health Canada and the FDA----
Mr. Burton. Well, I don't have any problem with that.
Mr. Catizone [continuing]. As well as licensing of those
pharmacies by U.S. State boards of pharmacy.
Mr. Burton. I don't have any problem with that. What I do
have a problem with are the pharmaceutical companies making all
of this money on the backs of American citizens when they are
selling the same product up there and making a profit out of
it. I don't believe in price controls. I believe in the free
enterprise system. But at the same time I don't believe
Americans should be raped by pharmaceutical companies when they
are selling the same product in other parts of the world for a
heck of a lot less money and we have the highest-priced
pharmaceuticals in the world, so they are levying all of the
profit or the biggest part of the profit on the backs of the
American citizens, and it is just not right. We should not be
discriminated against. And I am for the free enterprise system.
Thank you, Mr. Chairman.
Mr. Blumenthal. If I may add----
Chairman Tom Davis. Sure. Please.
Mr. Blumenthal [continuing]. Just a sentence or two, I, on
behalf of myself as the Attorney General of Connecticut, not
speaking for all of my colleagues across the country, would
very strongly welcome a more-transparent and free market
internationally that gives our consumers the benefit of lower
prices in an international or global market, which now is not
the case, so long as quality, contamination, adulteration,
dosage--all of those standard measures of acceptability--were
the subject of the United States oversight, which I think is
the purpose of your suggesting some kind of reciprocity
agreement.
Mr. Burton. That's right. And I appreciate your saying
that, General. Thank you.
Chairman Tom Davis. Thank you, Mr. Burton.
Mr. Towns.
Mr. Towns. Thank you very much, Mr. Chairman.
You know, Dr. Thompson, you mentioned legislation is needed
in a certain area, and I really didn't get that. Somehow I lost
that part. Where do we need legislation?
Dr. Thompson. Actually, we have offered to work with this
committee to help define the doctor/patient relationship, which
has been in the past a source of confusion and has led--has
caused a decrease at times in Federal action because of the
confusion about the doctor/patient relationship. We would
welcome an opportunity to help narrowly define that for the
purposes of Internet practice.
Mr. Towns. Right. But I thought you made some suggestions.
I thought you gave some specific suggestions that you felt were
areas in which we need legislation. I'll come back to you.
Dr. Thompson. Actually, there were three things. One is
that we would highly recommend that there be national
disclosure of the Internet sites and the physicians who are
prescribing the medications.
Second, we would strongly encourage some Federal
legislation to allow for injunctions against these Internet
pharmacies beyond the State jurisdictions. The States, as you
know, are restricted, and you heard testimony earlier about the
restrictions from going after pharmacies and businesses in
other States. Perhaps Mr. Blumenthal would care to expand on
that. But certainly we would like injunctive relief that would
help us go after pharmacies and businesses across State lines.
Mr. Towns. Thank you. Also, after you comment on that, Mr.
Blumenthal, at the same time I want to know your views on
uniformity in terms of the possibility for some guidelines that
would just cover all States.
Mr. Blumenthal. I think the need for uniformity is a very
real concern, and if I might suggest to the committee, there is
an excellent model, which is the Federal Telemarketing Sales
Act, as described earlier by Mr. Beales of the FTC. The Federal
agency there has the option to enforce a case. If the State
chooses to do so independently, it can go to Federal court, but
at least the FTC has the ability to enforce a national standard
in every case because it has what he aptly termed a ``right of
first refusal.'' And so the kind of framework that I am
suggesting--and I think it has been suggested widely--is that
there be the authority on the part of States to enforce a
standard that the FTC in a sense would supervise and assure
uniformity, but make it potentially nationwide in every case
through the Federal courts and give the States the option to
enforce their cases in Federal court, which would give much
more teeth to the present system.
I can't emphasize how important that would be as a
deterrent to these kinds of rogue pharmacies, because right now
they feel that they can simply move from one State to another,
that they can choose States where, for one reason or another,
enforcement authorities may not be as vigorous as they would be
in other States. They can avoid State court jurisdiction. They
can throw up procedural hurdles and technicalities. I think
many of those obstacles would be removed by this kind of
Federal system with Federal jurisdiction modeled on the Federal
Telemarketing Sales Act.
Mr. Towns. Right, because I'm not even sure what a valid
prescription is. What is a valid prescription? I'm not sure,
you know. Do you want to comment on that? That's the reason why
I think we need some Federal involvement here.
Dr. Thompson. Well, the State medical boards have been very
clear about the writing of a prescription, and in all
circumstances have enforced the notion that there should be an
adequate doctor/patient relationship, and this is not satisfied
by a survey over the Internet. It is only satisfied by a face-
to-face encounter with a physician, including a history and a
physical examination and some permanent documentation of that
encounter we know as a medical record. Those are at least the
minimal standards that the state Boards would require for a
doctor/patient relationship to be established prior to the
writing of a prescription.
Mr. Towns. Thank you. My time has expired, Mr. Chairman.
Chairman Tom Davis. Thank you very much.
General Blumenthal, let me ask you, Mr. Catizone has
already testified that the VIPPS program already requires
disclosure from its participating Web sites. It is an
established program. It has seen some very positive results.
What about States enacting legislation to make this
certification process mandatory? Is that helpful? Is it
possible? Is it probable?
Mr. Blumenthal. I think again, Mr. Chairman--and that
question is really a very important and key one--the States
could do so. Connecticut, as a matter of fact, has, at one
point or another, proposed to do so, but I think we need the
help of the Federal Government in enforcement.
Chairman Tom Davis. Absolutely.
Mr. Blumenthal. And the VIPPS program is excellent. It
works well. It is done in good faith by the NABP and I think is
an excellent model. We can expand on it and perhaps enact it
into law, but doing it State by State may not be the answer,
simply because of the enforcement difficulties I mentioned
earlier.
Chairman Tom Davis. I mean, the problem is you could shut
down a Web site and find the people. They can come up under
some other auspices somewhere else. And the fact is, because of
the price differential, consumers will take the chance and many
times just do it. It's almost impossible to police. I'm not
even sure the Federal Government could police it, but we would
obviously have more jurisdiction. Is that a fair comment?
Mr. Blumenthal. I think that is a very accurate and fair
comment, Mr. Chairman.
Chairman Tom Davis. Yes. Connecticut consumer protection
laws, in addition to medical and pharmacy laws, have served as
a vehicle for you to go after the Web sites. When does the
illegal dispensing of drugs become the issue for the Federal
level? When do we cross that threshold and it becomes a Federal
issue as opposed to a State issue?
Mr. Blumenthal. Well, I think there is overlapping
jurisdiction. As you've heard from the earlier panel, a
violation of Federal law could involve the same kinds of unfair
or deceptive advertising practices that we have prosecuted at
the State level. It's the reason that we have sued a number of
the Internet Web site pharmacies, as well as doctors. We sued
physicians who participated in those kinds of illegal
practices.
I think the Federal jurisdiction relates to the quality and
purity of drugs. We don't have the authority over, for example,
contamination, counterfeiting, mis-dosage, misbranding of drugs
in the same way that the Federal Government and specifically
the FDA does.
Of course, there are different issues of enforcement. We
don't have the same kind of powers to enforce Federal law now
in this area or to go into Federal court.
Chairman Tom Davis. OK.
Mr. Catizone, let me ask you, the VIPPS seal that you place
on--the VIPPS Seal of Approval that consumers ought to be able
to stand by, have people been stealing this seal illegitimately
and putting it on a Web site? Has this been a problem?
Mr. Catizone. No. The security systems we have in place
with our software people have prevented that from happening. If
we have detected any site where they have tried to copy it, it
is immediately known to us and we immediately take action
against that site also.
Chairman Tom Davis. OK. All right. Thank you.
Dr. Thompson, what type of actions can you take against a
physician who is illegally prescribing to consumers over the
Internet without first establishing a valid patient/physician
relationship?
Dr. Thompson. The disciplinary actions can include anything
from a hand slap to a revocation of a license. In fact, at
least four physicians have had their licenses revoked as a
result of prescribing over the Internet without establishing a
physician/doctor relationship. It includes anything from fines
to suspensions to, as I mentioned, revocation.
Chairman Tom Davis. It is not all black and white, though,
is it?
Dr. Thompson. No.
Chairman Tom Davis. Because even some of these illegitimate
sites are selling legitimate goods. We don't know that they
are. We can't prove that they are, but in many cases they
appear to be. It is giving consumers something they probably
may not be able to afford otherwise, but it is an unfair
competitive advantage and there are, as I think we've heard
from the last panel, risks involved that really have not been
articulated or measured appropriately--something maybe we need
to do a better job of before we move on.
I appreciate your being here. I appreciate your testimony
adding to this. Mr. Waxman has a bill. I think he might have
picked up a couple cosponsors on our side today as a result of
this.
Mr. Towns. Are we concluding?
Chairman Tom Davis. I'm going to let you ask more
questions, Mr. Towns, if you want to.
Mr. Towns. Thank you. I appreciate that.
Chairman Tom Davis. I'm just thanking and just saying I
appreciate for you really adding to our body of knowledge on
this. It's something a lot of Members aren't aware of. As you
see, it gets wrapped up in the whole prescription drug
controversy, legislation we're trying to pass this year but all
the contradictions that occur in a marketplace that is
cluttered sometimes with too much regulation and sometimes too
little regulation.
Mr. Towns, did you have any additional questions?
Mr. Towns. I do, Mr. Chairman. I just wanted to ask Dr.
Catizone a couple of questions. I understand that the National
Association of Boards of Pharmacy certifies Internet pharmacy
which meets certain criteria as verified. Internet pharmacy
practice sites are called VIPPS. Can you tell us about this
program, including how stringent the safety standards are and
how many Internet pharmacies you've certified to this date up
to date?
Mr. Catizone. The VIPPS program has very robust and
stringent criterion for approval and for certification. As Mr.
Blumenthal mentioned, we adhere to all of the various State
laws as part of that certification program, so a pharmacy that
operates in Illinois that wants to distribute medications in
Connecticut must follow all the laws for those patients in
Connecticut when dispensing those medications. We review the
licensure. We do an onsite inspection. We check all of their
State board inspection reports. We check all the disciplinary
actions against the pharmacy or pharmacist and then post that
information on the Web site for the patients to observe.
We have certified to date 13 sites representing 8,000 to
10,000 pharmacies in the United States.
Mr. Towns. I guess the next question would be how do you
determine that an Internet pharmacy site provides the
information consumers need? I mean, how do you tell, you know?
Mr. Catizone. There are a couple of different things we do.
As part of our onsite inspection we look at all of their
software programs for detecting adverse drug reactions,
interactions, contraindications. We also check all of their
procedures on how they adhere to the various State laws, and
then independently, using covert Web names, we go then and
search those sites and ask for information back from those Web
sites, time how long it takes for the information to come, test
their 1-800 numbers, and test their reaction to patient
problems with medications the site may have sent to them,
document that, review all that, and then set standards for
those sites to meet.
Mr. Towns. OK. If you find that they're actually violating
VIPPS program guidelines, you know, what do you do in a case
like that?
Mr. Catizone. If they are violating our guidelines they are
probably violating State laws, so we'll do one of two things.
One, we'll notify the States in which they are operating that
the you're probably violating their laws. Second, we'll move to
withdraw their certification immediately from that site.
Mr. Towns. All right. Thank you very much.
Thank you, Mr. Chairman, for allowing me to ask additional
questions.
Chairman Tom Davis. Thank you very much.
Again, I want to thank the panel. Is there anything else
anyone wants to add?
Mr. Blumenthal. Mr. Chairman, I might just respond to a
point that you made which I don't think has been made by anyone
else on the panel relating to the dangers of some of these Web
sites going beyond adulteration or inappropriate or mis-dosed
drugs. There are also very significant dangers of addiction and
abuse of drugs as a result of these Web sites. The kinds of
availability of, for example, very powerful pain killers,
hydrocodones, opiates that are, in effect, given out not only
affordably but abusively through a number of these Web sites is
a major problem, and so I think addiction is a major part of
the problem.
Chairman Tom Davis. Once you really take the physician out
of the equation, a lot of bad things can happen on this.
Mr. Blumenthal. Exactly. Thank you.
Chairman Tom Davis. Well, thank you very much. I want to
again thank you for your testimony today. It was an outstanding
panel. I'd like to thank the committee staff that worked on
this hearing and thank Mr. Waxman for calling this issue to the
committee's attention.
The hearing is now adjourned.
[Whereupon, at 12:30 p.m., the committee was adjourned, to
reconvene at the call of the Chair.]
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