Mr. Chairman, members of the Committee, it is a pleasure to
appear before you as we present the 1997 Food and Drug
Administration budget proposal.
We are fully conscious of the need to provide the best government
services for the taxpayers' dollars. It is therefore most that
we can support our request for essentially the same budget as
last year with evidence that FDA is providing critical public
health protection, and that the agency's performance is
continuously improving.
FDA's activities, which ensure the quality of $1 trillion worth
of products, are always too numerous to list in our annual budget
presentation. Last fiscal year was no exception, and I will only
mention a few of its highlights to illustrate the agency's
continuing strides to promote and protect the public health.
FDA's Center for Devices and Radiologic Health certified 10,200
mammography facilities from coast to coast, thereby improving the
quality of mammography for all women. This program, mandated by
the Mammography Quality Standards Act of 1992, was implemented in
record time to meet the Congress-specified timetable. By the end
of this year, an estimated 185,000 American women will be
diagnosed with breast cancer. The new mammography standards and
the mandated on program now in force will improve the chances
that their disease will be detected in early stages, when it can
be best treated. A significant FDA proposal published last year
outlined a new patient information program that creates market
incentives to provide useful written information with each filled
prescription for drugs. The proposal is designed to increase
patients' familiarity with the drugs they use, their potential
adverse effects and the importance of the prescribed regimen.
Studies have shown that lack of such information significantly
contributes to widespread medication misuse that adds an
estimated $20 billion to the nation's annual health care bill and
causes great losses in productivity.
As part of the Vice President's National Performance Review, FDA
last year proposed substantial changes in the way we regulate
drugs, medical devices and medications made using bio-technology.
The six regulatory proposals to reform the regulation of
biologics represent the most significant overhaul of regulation
of well-characterized biotech-derived drugs ever attempted by the
agency. In essence, FDA proposed to completely harmonize its
regulation of such products across the agency.
For most biotech drugs, FDA will eliminate its existing
requirement that manufacturing plants be licensed; do away with
the existing requirement that test results for each individual
lot of biotech drugs be submitted to the agency after the product
has been approved by the agency; and the agency will consolidate
its 21 different application forms for biotech drugs into one
form.
These and the other proposed changes in device and drug
regulation will save the companies product development time and
tens of millions of dollars, without lowering FDA's high
standards of safety and efficiency. We took a major step to
improving the safety of our seafood by issuing the final rule
instituting in the industry the so-called HACCP (Hazard Analysis
and Critical Control Points) system, which focuses on preventing
problems before they occur and designing safety into the
processing of seafood.
Finally, FDA made one of its potentially greatest contributions
to the nation's public health by proposing new ways of keeping
cigarettes and smokeless tobacco products out of the reach of our
teenagers. More than 400,000 Americans die each year of lung
cancer, respiratory illnesses, heart disease and other
smoking-associated diseases -- more than the combined annual toll
of AIDS, alcohol, car accidents, murders, suicides, illegal
drugs, and fires. Since smokers almost always become addicted to
nicotine in tobacco during their teenage years, our proposal has
the potential of sparing this country enormous amount of personal
suffering, lost productivity, and medical expenditures.
I could cite many other activities carried out by the agency in
its daily work to protect American consumers and promote the
public health. But I believe that what puts FDA's performance
most clearly in perspective are three recent reports which probe
one of the agency's most frequently criticized core functions,
the drug review process.
Two of these reports were submitted to Congress. One is the
agency's review of last year's progress in implementing the
Prescription Drug User Fee Act (PDUFA), and the other, a General
Accounting Office (GAO) study of FDA's drug approvals, was
released in October. The third is FDA's own analysis of the
agency's performance in the international arena by comparing the
American patients' access to important new drugs with access to
such drugs by patients abroad.
Taken together, these reports profile in depth the invigorating
change in the FDA culture began some years ago as the agency
added modern, efficient management techniques to its
traditionally solid scientific base.
This trend is best reflected in the drug review times achieved
since the 1992 passage of PDUFA, under which the agency committed
itself to very high performance standards. The annual goals rise
steeply each succeeding year.
We already have achieved one major 1997 performance goal. We
achieved it in fiscal year 1994 - a full three years ahead of
schedule. For the drugs submitted to FDA in fiscal year 1994, we
reviewed and acted upon 96 percent of them on time. In most
cases, this meant first action occurred ,within 12 months.
In addition to the new drug applications, PDUFA sets the pace for
the agency's review of two types of supplementary applications --
dealing with effectiveness and manufacturing -- for resubmitted
applications, and for elimination of backlogs. Rather than
reiterating the extensive data last year's results in all of
these categories as being on target or ahead of schedule.
The PDUFA performance targets were established in 1992 in a
three-stage process that we regard as a model for reinventing
government. First, Congress, government experts, the industry
and consumer groups developed a consensus on performance goals.
Next, we agreed on the timetable when these goals have to be
reached. And last, but equally important, FDA was given the
resources to make the program work.
Although by PDUFA, FDA's faster drug reviews cannot be solely
credited to the Act. The agency's advance toward shorter
approval times started in the late 1980s, when FDA scored
significant performance improvements. These early advances are
documented in the second report I mentioned. GAO's study of "FDA
Drug Approval" tracked the agency's handling of new drug
applications (NDAS) submitted from 1987 to the end of 1992, and
found solid evidence of progress. "We found a considerable
reduction in approval time... " the report states. "It took an
average of 33 months for NDAs new drug applications submitted in
1987 to be approved but only 19 months on average to approve NDAs
submitted in 1992. Further, the reduction in time was observed
for all NDAs and not just for those that had been approved...
The consistency of all our results supports the conclusion that
the reduction in time is real..."
GAO also compared the most recently available data on the speed
of drug approvals in the United Kingdom and the U.S. The report
concluded that while comparisons between the British Medicines
Control Agency and FDA are difficult for a variety of reasons,
the most recent data show that overall approval times are
actually somewhat longer in the U.K. than they are in this
country.
For us, the GAO comparison of FDA's performance with its British
counterpart, confirmed a fact which is not widely known and even
less acknowledged: the agency leads the world in rapid and
efficient review and approval of new drugs.
Evidence of the agency's performance can also be seen in our
response to the AIDS epidemic. FDA makes a maximum effort to
speed all needed therapies to those who are suffering. In the
last four months of 1995, for example, the agency approved 15
drugs for the treatment of cancer. But our progress in approving
new breakthrough drugs has been particularly notable in AIDS
therapies, all but one of which have been made available in this
country well ahead of the rest of the world.
AZT, the world's first effective anti-retroviral was approved
here in 1997, at about the same time as in France and United
Kingdom, and a month ahead of Germany. DDI, the second
anti-retroviral received FDA's approval months ahead of France,
ten months ahead of Germany, and 29 months ahead of the UK. DDC
was allowed on the American market a year and a half ahead of
France and Germany, and 27 months ahead of the U.K.
D4T, the fourth drug against AIDS, was approved in France,
Germany, and the United Kingdom in January of this year. In the
U.S., it was approved in June 1994. 3TC, which FDA approved in
November 1995, is yet to be approved elsewhere. Saquinavir and
ritonavir, the two antivirals that FDA approved since last
December, are also awaiting foreign approvals. The review of
saquinavir took 97 days, and ritonavir was approved in just 72
days, a new record for the AIDS therapies. Both products are
protease inhibitors, the first new class of AIDS drugs since AZT.
Other important drugs that FDA approved well ahead of its
counterpart agencies included taxol for ovarian cancer,
fludarabine for chronic lymphocytic leukemia, donum alpha, also
called DNAse or Puhnozyme, for cystic fibrosis, Betaseron for
multiple sclerosis, and rfluzole for Lou Gehrig's disease.
To more fully evaluate FDA's worldwide standing, we last year
performed a study comparing the availability of new drugs here
and in England, Germany and Japan, the countries which together
with the U.S. account for 60 percent of global pharmaceutical
sales.
Our analysis focused on 185 new drugs -- out of the worldwide
total of 214 -- that were launched in at least one of the four
surveyed countries between January 1990 and December 1994, the
most recent five-year period for which we could get the data.
Once the data base was assembled, we asked a number of questions:
First, we wanted a two-country comparison between the U.S. and
each of the other three countries to see, comparatively, when
drugs were approved. In every case, for the time period studied,
the U.S. was the first to approve more of the drugs that
eventually became available in both countries. Of the 58 drugs
that were approved both here and in the U.K., 30 were approved
first in the U.S. The U.K. was ahead of us in approving the
remaining 28. But if our edge over the U.K. was only slight, the
disparity between us and the other two countries was much bigger.
We were first in approving 31 of the 44 drugs approved both in
the U.S. and Germany, and we were ahead of the Japanese in
allowing marketing of 10 of the 14 compounds eventually used in
both countries.
When we looked at the comparison of when these drugs became
available to patients, there were other surprises. Of the 30
drugs that reached our market ahead of the U.K., we were faster
than the British by an average of 17 months. Of the 28 drugs that
the U.K. sent to market first, their average lead was not quite
16 months. In comparison with Germany, we get drugs that both
countries approve to the market about 18 months Faster -- on
average -- than the Germans when we market the drug first. They
get to market on average of 11 months faster than us when they
approve it first.
When a drug is approved in both the U.S. and Japan, the U.S. gets
it to market on the average nearly two years before the Japanese.
When they approved a drug first, they did so by an average of
about 19 months.
But what about the drugs that have been approved in those other
countries, but not approved in the U.S.? Do European and Asian
citizens have important pharmaceuticals available to them that
are not available in America? And if so, are these drugs
clinically significant?
Of all the therapeutics from these 214 on the market worldwide
that we have not approved, only a small handful could be
considered important molecular entities -- i.e., drugs that offer
at least a modest therapeutic advance over existing products, or
can be used to treat conditions for which no therapy now exists.
Everything else is a standard drug with an essentially equivalent
product already on the American market.
Here is what we found: In England there are 29 drugs from this
important group that are not approved in America. Conversely, we
have 18 drugs on the market that they do not.
When we studied the list of drugs they had but we did not, we
found two that we thought might be priority drugs. One was
remoxipride, which appeared to be a promising new treatment for
schizophrenia. The English approved it, but as more and more
patients took the drug, it was found that in some of them it
caused the bone marrow to shut down, causing aplastic anemia, a
life-threatening disease.
The other drug was centoxin, a biotech product of an American
company to treat sepsis caused by gram-negative bacteria. It was
also approved in the U.K., while FDA did not find that the data
demonstrated safety and efficacy. We asked the company to carry
out another study which eventually showed that the drug did not
work, and that it might actually increase the risk of patient
death.
Both of these drugs have been taken off the world market.
There is one other set of international data that bears on an
issue of current interest. As the agency's review and approval
tunes have grown shorter, we have heard increasingly frequent
claims that the overall time to develop a drug has grown longer.
If true, this would be a disturbing trend.
FDA has not been able to conduct its own study of overall drug
development times, but there is some information in the
literature that does not support these statements. According to
a recent study by the Centre for Medical Research, a private
organization that works closely with the Association of the
British Pharmaceutical Industry, there has been no real change in
drug development times since 1980. The Center checked the
development time of 700 drugs in 20 countries -- including the
U.S. -- and found that between 1980 and 1994, the mean
development time varied between 10 and 12 years. In 1994, it was
11.5 years.
Drug development time before an application is submitted to FDA
is influenced by factors that in most cases are not under the
control of the agency. To such extent as the agency can
facilitate the process by clarifying to sponsors what studies are
needed to win rapid approval for their products, we are committed
to do so. When it comes to potentially unique life-saving drugs,
FDA time and again takes the initiative to work hand in hand with
the drug developers to expedite the approval process. Fast
access to new drugs and devices ranks at the very top of the
concerns of the agency.
Important as they are, drug approvals are only one of many
concerns of FDA, whose responsibilities include thousands of
products of importance to the public health.
The agency has also made improvements in the times for the review
and approval of medical devices. With respect to the so-called
510(k) which 98 percent of all medical devices evaluated by FDA
reach the market, the average review time in fiscal year 1995 was
137 days, down 24 percent from the 194-day average in fiscal year
1994. The average review time for those devices needing
pre-market applications (PMAS) is stiff too long, but we are
making progress there as well. The average PMA review time in
fiscal year 1995 was 20 months.
It is important to remember, however, where the Agency was in the
1980s. Congress found -- as did FDA -- that the scientific and
medical for the review of medical devices were lacking. FDA
looked at devices the way an engineer would, and we failed to
focus sufficient attention on whether the device would actually
make the patient better. Congress told us to do better, and we
have. The clinical standards for medical device reviews have been
bolstered significantly, and now we are hard at work on reducing
the review times.
We are making similar efforts to increase the timeliness and
predictability of our action on food and color additive
petitions. firm in order to address the backlog of pending
petitions, we have allocated additional resources to the program:
23 additional agency scientists have been reassigned temporarily
to the food additive program; the agency is awarding contracts
for expert review of certain portions of food additive data
packages; and one and one-half million dollars have been spent on
enhanced computing facilities for the program. With these
efforts we will begin to see a decrease in the petition
inventory. In addition to these added resources, we instituted a
threshold of regulation policy under which indirect food
additives that do not present any substantial safety concerns are
exempted from the petition process. The agency processed 47
submissions under this now policy in 1995.
This review of FDA's performance would be incomplete without at
least a brief reference to the many activities undertaken in
pursuit of our mandate as a science-based consumer protection
agency. FDA investigators were involved last year in hundreds of
cases involving the manufacture, imports or distribution of
dangerous or potentially hazardous products.
One example of their activities involved a Massachusetts shrimp
company which was adulterating its products with three chemicals:
it used saccharine to overcome an undesirable taste, sodium
hydroxide to alter the color, and sodium tripolyphosphate to
increase the yield. The president of the company was convicted
on 101 counts and sentenced to three years in prison, to be
followed by two years of supervised release.
Another important consumer protection action, carried out in
cooperation with the U.S. Customs Service and the U.S. Department
of Agriculture, halted the smuggling into the U.S. of large
quantities of clenbuterol and other unapproved drugs that were
then mixed in feed sold to veal producers throughout the Midwest.
Clenbuterol is used in some countries to increase muscle in
animals, but traces of the drug in meat products have caused
outbreaks of food poisoning in France and Spain. FDA discovered
that the drug was reaching this country when it appeared in
animals shown in agricultural competitions. The indicted
Wisconsin feed distributor is awaiting sentencing.
Finally, FDA's criminal investigation continues to play a role in
shielding the public against dangerous product tampering. A
recent case which they helped to swiftly resolve in cooperation
with FBI involved the tampering of a baby formula and an
attempted blackmail. The suspect was apprehended before his
scheme caused any bodily harm, and has been indicted by a federal
grand jury.
All of our activities follow the two principles that have guided
Congress and FDA in setting regulatory policies: products that
are important for the public health must be safe and effective.
If a drug or a medical device is not safe, it should not be
approved or allowed to harm consumers. If it does not work, it
is of no value to the public, and has no justification in the
market place.
These principles are a proven success. They have made FDA's
rigorous product evaluation a lasting and effective shield for
the nation's public health, and have helped make American
therapies and devices sought-after throughout the world.
We are determined to maintain those standards, Mr. Chairman. We
will be fast - and keep on working at getting faster -- while
continuing to protect the public health. The principles of
safety and effectiveness, speed and caution are not at
cross-purposes: they work in harmony for the benefit of the
American consumer, whose health is our most important
achievement.
Turning to FDA's FY'97 budget request, the Administration's
budget includes a total FDA request of $1,024.2 million. This
consists of $879.4 million in budget authority, $106.3 million in
authorized user fees and $39.5 million for two new use fees
proposed for legislation. The budget authority is maintained at
the FY '96 level. The user fees reflect modest increases in
existing user fees and the two new proposed additive user fees,
for Medical Devices and Imports. Without an increase in non user
fee areas, FDA is absorbing cost increases necessary for the
agency to carry out its primary mission. The highlights of our
FY97 request are as follows:
Food Safety Initiatives +$3.8 Million
FDA proposes a series of Food Safety initiatives to address
current concerns and to meet the issues we are likely to
encounter as we enter the 21st century. The initiatives include
expedited implementation of the new Seafood HACCP regulation
($1.2 million); Federal and state partnerships to enhance food
safety ($1.2 million); and new approaches for the review of food
additive petitions ($1.4 million). For FY 1997, FDA is applying
a $3.8 million increase to its operating base to cover the
anticipated FY 1997 cost of these initiatives.
Buildings and Facilities -$3.3 Million
The FY 1997 budget request for buildings and facilities of $8.4
million is $3.8 million below the FY 1996 level. The requested
$8.4 million will enable the Agency to maintain its many
facilities nationwide by addressing only our most urgent repair
and improvement requirements. Mammography Quality Standards Act
(MQSA) +$0.4 Million (user fees)
In FY 1997, federal and state personnel will inspect 10,000
mammography facilities and conduct 3,000 facility certifications.
To meet the costs of the program, FDA requests an increase in
MQSA authority inspection user fees of $0.4 million for a total
of $13.4 million and 35 FTES.
Prescription Drug User Fees Act (PDUFAI +S2.8 Million
FDA requests an increase of $2.8 million in FY '97 and estimates
total user fees of $87.5 million and 700 FTE to implement PDUFA
in FY 197. As envisioned in the Act, this level of support will
enable the Agency to diminish significantly the time necessary to
review new prescription drug and biological product license
applications. In FY '97, 90 percent of filed New Drug
Applications (NDA) and Product License Applications
/Establishment License Applications (PLA/ELA) submissions are to
be reviewed within 12 months.
In addition to the existing user fees, FDA will be seeking
separate legislative approval of the following additive user
fees:
Medical Device Review - User Fees +S24.5 Million
FDA is requesting $24.5 million in additive user fees, to be
collected from the medical device industry. These application
fees will enable the agency to promptly review device
applications. If user fee legislation is adopted, we have
committed to making decisions on 510(k) applications within 90
days. Ninety-nine percent of all pre-market applications are
filed under section 510(k). We have also committed in connection
with user fee legislation, to review the more complicated PMA
applications within 180 days.
For FY '97 the user fee goal is to increase the percentage of
510(k) applications completed within 90 days from 50 percent in
FY95 to 90 percent to increase the percentage of first review
cycles for PMAs completed within 180 days from 45 percent in FY95
to 75 percent. The proposed user fees will help to increase
industry guidance, strengthen post-market monitoring, improve the
Agency's ability to assess public health risks, and upgrade
automation capabilities and integrate program information
systems.
Import Inspection Enhancement - User Fees +$15.0 Million
FDA is proposing to collect $15.0 million in additive import user
fees to fund the Operational and Administrative System for Import
Support (OASIS). The system is expected to enable the agency to
substantially reduce the risk of potentially harmful foods and
other imported products reaching the American market place. The
importer/ broker community benefits through faster turn-around
times, elimination of large volumes of paperwork, and reduced
costs of doing business. OASIS will give FDA staff access to
historical information to better target high risk products and
firms, the ability to plan inspections more effectively, and the
ability to share findings from inspection and lab analyses with
other offices.
*There are 14 charts attached.
Chart 1
Reinventing FDA - Under Development
- Third party review pilot program for medical devices
- Harmonized application for all drugs and biologics
- Elimination of GRAS substance reviews
- Reform of food addictive petition process
- Greater use of the private sector in monitoring imported foods
- Relaxation of animal drug exports (requires statutory change)
- Elimination of medicated feed application (requires statutory change)
- Elimination of antibiotic and insulin monographs (requires statutory change)
- Automated management processes (SMART)
- Automated import entry system (OASIS)
Chart 2
Reinventing FDA - Completed
-
Eliminated establishment licenses for most biotech drugs
- Eliminated lot release for most biotech drugs
- Allowed use of pilot facilities for biological drug development
- Eliminated FDA review of hundreds of medical devices
- Implemented new food safety system (using performance standards)
- Eliminated FDA approval of manufacturing changes for drugs and biologics
- Eliminated medical device "Reference List"
- Published policy statement that new drugs not be proved more effective than other drugs
- Relaxed medical device export policy
- Provided exemptions from most environmental impact policy
Chart 3
Twelve Month User Fee Goals Applications
submitted in:
- FY 1994 -- 55% on time
- FY 1995 -- 70% on time
- FY 1996 -- 80% on time
- FY 1997 -- 90% on time
Chart 4
Twelve Month Review*
New Drugs and Biologics
- Actual 96 % on time
Goal 55% on time
*If major amendment submitted late in the process, an additional
three months is granted.
Chart 5 - (Bar Graph)
General Accounting Office Analysis of Average
Drug Approval Time 1987 - 1992
Shows: The average Drug Approval time in number of months in each year.
-
The highest number of average drug approval was in 1987
- at about 33 months;
about 30 months in 1988;
about 26 months
-
in 1989 and 1990;
- and the lowest in 1992
- at about 20 months in 1992.
Chart 6 - (Bar Chart)
GAO Comparison of US/UK Approval Time - 1994
-
Compares US and UK: US approved at a median of 18 months in
comparison to UK approved at a median of 30 months.
Chart 7
Antiretrovirals Currently Approved
For HIV infection & AIDS-related conditions |
Product |
Approval |
Review Time to Approval |
AZT |
March 1987 |
3.5 months |
ddl |
October 1991 |
6 months |
ddC |
June 1992 |
8.5 months |
d4t |
June 1994 |
6 months |
3T |
November 1995 |
4.5 months |
saquinavir |
December 1995 |
3 months |
ritonavir |
February 1996 |
2.5 months |
Chart 8
Dates of Approval |
|
ritonavir |
saquinavir |
3TC |
d4T |
ddC |
ddl |
AZT |
USA |
02/96 |
12/95 |
11/95 |
06/94 |
06/92 |
10/91 |
03/87 |
France |
Not yet Approved |
Not yet Approved |
Not yet Approved |
01/96 |
01/94 |
05/92 |
03/87 |
Germany |
Not yet Approved |
Not yet Approved |
Not yet Approved |
01/96 |
01/94 |
08/92 |
04/87 |
UK |
Not yet Approved |
Not yet Approved |
Not yet Approved |
01/96 |
09/94 |
02/94 |
03/87 |
Chart 9
Dates of Approval |
|
Fludarabine |
Taxol |
Dornase Alpha |
Interferon Beta-1B |
Riluzole |
US |
04/91 |
12/92 |
2/93 |
07/93 |
12/95 |
France |
05/94 |
11/93 |
03/94 |
11/95 |
Not yet Approved |
Germany |
Not yet Approved |
11/93 |
09/94 |
11/95 |
Not yet Approved |
UK |
11/94 |
11/93 |
01/94 |
11/95 |
Not yet Approved |
Chart 10
New Drugs Approved in US But Not in UK
- Benazepril
- Cefprozil
- Dezocine
- Doxacurium Chloride
- Felbamate - Restricted in US - 1994*
- Gallium Nitrate
- Halobetasol
- Histrelin*
- Imiglucerase*
- Interferon Alfa-N3
- Interferon Beta-1B*
- Masoprocol
- Merieux Varicella Vaccine
- Pegademase Bovine*
- Pegaspargase
- Stavudine (d4T)*
- Succimer*
Tacrine*<
*Priority drugs
Chart 11
New Drugs Approved in US But Not in Germany
- Cefprozil
- Cladribine*
- Dezocine
- Doxacurium Chloride
- Factor VIII - rDNA (Kogenate)*
- Felbamate - Restricted in US - 1994*
- Flosequinan - Withdrawn WW 1993
- Fludarabine*
- Fluosol - Perfluorocarbon
- Halobetasol
- Histrelin*
- Imiglucerase*
- Interferon Alfa-N3
- Interferon Beta-1B*
- Lodoxamide
- Losartan
- Masoprocol
- Merieux Varicella Vaccine
- Mivacurium*
- Moricizine*
- Nefazodone
- Pegademase Bovine*
- Rocuronium Bromide
- Salmeterol*
- Sargramostim (GM-CSF)*
- Sertraline
- Stavudine (d4T)*
- Succimer*
- Tacrine*
- Trimetrexate
- Venlafaxine
* Priority drugs
Chart 12
New Drugs Approved in US But Not in Japan
- Alglucerase*
- Atovaquone*
- Calcipotriol
- Cefprozil
- Cladribine*
- Colfosceril*
- Desflurane
- Dezocine
- Dornase Alfa*
- Doxacurium Chloride
- Eflornithine*
- Factor VIII - rDNA (Recombinate)*
- Famciclovir
- Felbamate -Restricted in US - 1994*
- Finasteride*
- Flosequinan - Withdrawn WW 1993
- Fludarabine*
- Fluosol - Perfluorocarbon
- Fluvastatin
- Fosinopril
- Gabapentin*
- Gallium Nitrate
- Halobetasol
- Hepatitis A Vaccine - Havrix
- Histrelin*
- Idarubicin*
- Imiglucerase*
- Interferon Alfa-N3
- Interferon Beta-1B*
- Interferon Gamma 1B*
- Ketorolac - Withdrawn Ger 6/93 &
FRA 12/93*
- Lamotrigine*
- Levocabastine*
- Lodoxamide
- Loracarbef
- Losartan
- Masoprocol
- Merieux Varicella Vaccine
- Milrinone (IV)
- Mivacurium*
- Moricizine*
- Nefazodone
- Paclitaxel (Taxol)*
- Paroxetine
- Pegademase Bovine*
- Pegaspargase
- Rifabutin*
- Risperidone*
- Rocuronium Bromide Salmeterol
- Salmeterol*
- Sargramostim (GM-CSF)*
- Sertraline
- Stavudine (d4T)*
- Succimer*
- Sumatriptan*
- Tacrine*
- Tazobactam (Combo)
- Temafloxacin Withdrawn WW 6/92
- Torasemide (Torsemide)
- Trimetrexate
- Venlafaxine
- Zalcitabine (DDC)*
FRA 12/93*
*Priority drugs
Chart 13 - (Bar Graph)
Who is first?
Drugs approved in both countries
Compares the US to UK, Germany, and Japan in the number of
drugs first approved by the country.
Shows: US first approved 30 drugs to UK's 28; US first
approved 31 to Germany's 13; and US first approved 10 to
Japan's 4.
Chart 14 - (Bar Chart)
How much faster?
Drugs approved in both countries
Compares US to UK, Germany, and Japan as to how fast on the
average in months do the the countries approve drugs.
Shows: US approves drugs in 17 months to UK's 15.8 months;
US approves drugs in 17.9 months to Germany's 10.8 months;
and US approves drugs in 22.4 months to Japan's 18.5 months.