Text
only of letters sent from the Commerce
Committee Democrats. |
July 1, 1999
Mr. Carmen Catizone
Executive Director
National Association of Boards of Pharmacy
700 Busse Highway
Park Ridge, Illinois 60068
Dear Mr. Catizone:
The Committee on Commerce has been investigating a number of issues
pertaining to the sale of pharmaceutical products over the Internet. Committee staff have
met with the Food and Drug Administration (FDA), Department of Justice (DOJ), Federal
Trade Commission (FTC), and several state agencies involved in the regulation and sale of
pharmaceuticals. These meetings have attempted to determine: (1) the extent of this
problem, (2) the jurisdiction of each agency involved and the activities now being
undertaken by each in this matter, and (3) specific changes to current law (if any) that
might be needed to address this problem.
As you are well aware, pharmacies are regulated by state boards of
pharmacies which work in conjunction with the appropriate state agencies to ensure that
operating pharmacies are properly licensed and exercise suitable controls and practices
over the distribution of pharmaceutical products. Although oversight of these "brick
and mortar" pharmacies has been a relatively straightforward process, the emergence
of Internet pharmacies poses significant challenges to the existing system. Online drug
sites can now be located in almost any state or country having phone lines, yet easily
sell to consumers anywhere in the U.S. market. To complicate matters further, some online
pharmacies may not have a single location for a state to regulate, but may be located
across several states or jurisdictions. For example, an online pharmacy might place its
computers and offices in one state, its prescribing doctor(s) in another, and the actual
pharmacy filling the prescriptions in a third state, all while the purchaser resides in a
fourth state. Clearly, this situation creates significant challenges and risks for both
regulators and consumers.
In response to public concern about the safety of these sites, the
National Association of Boards of Pharmacy (NABP) has developed the Verified Internet
Pharmacy Practice Sites (VIPPS) program. Essentially a "Good Housekeeping" seal
of approval, this program is designed to provide site users some assurance that a
pharmaceutical site has received at least some scrutiny and meets certain standards. As
NABPs Web site indicates, VIPPS pharmacy sites are identified by the VIPPS hyperlink
seal displayed on each sites main page. By clicking on the seal, a visitor is linked
to the NABP VIPPS site where verified information about the pharmacy is maintained by
NABP.
While we agree that this is a laudable first step to the challenges
posed by Internet drug sites, a host of problems still exist, and will probably continue
to exist even after the VIPPS program is in place. For example, most sites now operate
without any VIPPS seal, and it is unclear when or if the public will ultimately understand
what the VIPPS does, or make purchasing decisions because of it. Moreover, some
individuals appear to gravitate to fringe sites because of the very activities the
VIPPS program is trying to prevent (e.g., the site doesnt require a prescription or
the site requires only a dubious online consultation). Because VIPPS is a voluntary
program, it is unclear how such an effort would ever address many of these unlicensed
fringe sites. Finally, because NABP is not a regulatory authority, it is not clear to us
whether NABP will have the resources to provide adequate scrutiny or review of all
VIPPS-candidate sites or how it will enforce sanctions against any VIPPS operators should
they later engage in bad practices.
Given the rapidly expanding nature of online pharmacies and the
significant challenges they are presenting to both state and federal regulators, we are
interested in knowing more about what NABP is doing generally about online pharmacies, and
particularly more about the VIPPS program. Accordingly, we would appreciate it if your
organization could respond to the following questions:
(1) Please describe the NABP standards that an
online pharmacy must meet and maintain in order to acquire and keep a VIPPS accreditation.
(2) Please describe the steps each online pharmacy
must go through to get a VIPPS accreditation, including: (a) the documents that must be
filled out or the types of documents that must be submitted; (b) the components of a
company that will be inspected by NABP and what such an inspection will entail; (c) the
persons (and qualifications of the persons) conducting such inspections, and (d) the
average cost expected for each inspection. Please also include your estimate of the
average amount of time the entire application/inspection process will require.
(3) How many online drug sites does NABP currently
believe are licensed by any State Board of Pharmacy? How many online sites does
NABP estimate are currently selling prescription drugs to U.S. consumers without a
license?
(4) How many online pharmacies have applied to the
NABP for VIPPS accreditation and how many have you now inspected? Of such applicants, what
kinds of VIPPS non-compliance issues has the NABP identified?
(5) Once an online site qualifies for a VIPPS seal,
how often will NABP reinspect the site to determine if the Internet site is operating in a
manner consistent with the NABPs original requirements? Further, since NABP is not a
regulatory body, if a site deviates from NABPs requirements, what actions can or
will NABP take to bring the site back into compliance? If a site disagrees with the NABP
regarding any aspect of compliance, is there a resolution process? If a disagreement
between a site and the NABP persists (e.g. the site remains non-compliant with NABP
guidelines), will information about the site be provided to either state or federal
regulators?
(6) Please provide a listing of the agencies and
organizations that participated in developing the VIPPS program. Please also describe each
agency or organizations role in this regard.
(7) Please describe how the individual State Boards
of Pharmacy will prepare for this program. Does NABP believe they currently have the
trained personnel and finances to implement this program on a state-by-state basis? If
not, how long will it take to have such requirements in place?
(8) Will individual medical record privacy be
included in the standards developed for accreditation by the VIPPS program? If so, please
describe how this will be implemented and enforced.
(9) In cases where sites are offering prescription
drugs without a license, what does NABP believe to be the source(s) of such drugs? E.g,
are they possibly counterfeit? Are they possibly authentic drugs, but diverted from
foreign or other sources? Please explain.
(10) Does the NABP believe there may be threats
with hackers stealing the VIPPS seal and placing it on an unapproved site? What will
prevent unscrupulous sites from fraudulently linking to the NABP web site or to a dummy
site that attests that the web site is accredited under the VIPPS system? How secure will
the actual NABPs VIPPS certification database be from outside infiltration by
hackers? Are there other related problems you foresee in this area?
(11) When an individual links to the NABP web site
through a VIPPS certification seal what exactly will the potential buyer discover? For
example, will the user arrive directly at an information screen regarding the particular
online web site they linked from, or will it be a general site from which they must
search for information about the site in question?
(12) Will NABP be developing any efforts to educate
consumers about the VIPPS program and the potential dangers of ordering pharmaceuticals
over the Internet? Specifically, for example, how will a user know that a VIPPS
certification seal makes an online pharmacy legitimate?
(13) Does NABP have a position on the suitability
of so called "online consultations" where a doctor actually "reviews"
patient information and then determines through this consultation if the patient should
receive a prescription? Does the NABP have specific guidelines/criteria/standards for this
type of site?
(14) If so, what guidelines/criteria/standards will
you use to prove that there is a "meaningful consultation between a patient and a
pharmacists"?
(15) Does the NABP have a position on how
doctors prescriptions should be handled in regard to online pharmacies? For example,
what form of communication for a prescription does NABP find acceptable: mail, phone, fax,
email, other? How will the authenticity of prescriptions under any of the NABP-approved
communication methods be verified?
(16) Does the NABP perceive it as one of the
functions of the State Boards of Pharmacy to seek out online pharmacies within the
boundaries of their State? If so, how will the Boards carry out this task and what kind of
action can they or will they take upon uncertified online pharmacies? If not, whose role
is it to find online pharmacy web sites within a States boundaries?
(17) Finally, how does NABP believe that the U.S.
consumer should be protected from foreign online pharmacy sites?
Thank you for your cooperation and attention to our request. We look
forward to continuing working with the NABP on these important consumer protection and
public health issues. If you have any additional questions about this matter, please have
your staff contact Mr. Christopher Knauer of the Commerce Committee minority staff at
(202) 226-3400.
Sincerely,
JOHN D. DINGELL
RANKING MEMBER
COMMITTEE ON COMMERCE
RON KLINK
RANKING MEMBER
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
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