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Drug
Company Fees For FDA Reviews Haven’t Accelerated Approvals,
Study Finds
12/17/2003
Source: University of Michigan Health System
Study also fails to find evidence of approval bias favoring
big drug companies For the past ten years, drug companies have
paid the U.S. Food and Drug Administration fees to review each
new drug they want approved. But a new study shows that this
program hasn't made the approval process any quicker -- its
main goal -- than increased federal funding for the FDA was
already doing before the industry fee program began.
The study, by a team from the University of Michigan and
Harvard University, also counters critics' claims that the
fee-based system might cause the FDA to give special treatment
to larger, more powerful drug companies. The researchers found
no evidence that those firms got faster approvals for their
products. The results will be published online Dec. 17 by the
journal Health Affairs.
"The bottom line is that the more staff the FDA has
reviewing drug applications, the faster the approval process
will be," says senior author A. Mark Fendrick, M.D., of
the U-M Medical School and School of Public Health. "If
you want more rapid assessment of new drugs, hire more people.
And if you're still concerned about external influence or
potential conflicts, fund them through additional
mechanisms."
Fendrick and his colleagues compiled the new findings using a
detailed analysis of 843 new drugs submitted for FDA approval
between 1977 and 2000, including 320 drugs that were rejected.
They looked at approval times for the drugs submitted in each
year, and concurrent levels of FDA drug-review staffing. The
analysis also included scrutiny of each drug's disease
indications, and each drug company's sales totals, number of
recent FDA submissions and lobbying budget.
The results enabled the researchers to see trends both before
and after the passage of the Prescription Drug User Fee Act (PDUFA)
in 1992. PDUFA set fees that companies pay to the FDA, to
offset the cost of hiring additional reviewing staff. In the
10 years since PDUFA took effect, companies have paid about $1
billion in fees.
Overall, the average time from a drug's submission to its
approval decreased dramatically over the 13 years studied,
from 24 to 36 months in the 1980s to roughly 14 months in the
late 1990s. The researchers also report that the number of FDA
staff reviewing drug applications rose steadily throughout the
period from 1980 to 1998.
In fact, staffing levels were growing rapidly for about five
years before PDUFA took effect, because of increased federal
funding to the FDA budget. The researchers found that this
prolonged, steady rise in review staff, not any particular
aspect of PDUFA, was responsible for the drop in approval
times.
In all, the average review time for a drug dropped by 3.3
months for every 100 additional FDA staff hired. If FDA
staffing had stayed constant at 1980 levels throughout the
1980s and 1990s, the researchers show, average drug approval
time would have stayed around 24 months.
Says Harvard government professor and lead author Daniel
Carpenter, "The effect of enhanced staffing levels on
decreasing approval times was substantial and observable
several years before PDUFA was passed. Analyses designed to
identify other effects of PDUFA, beyond those attributable to
increased staff, was unrevealing."
Moreover, says Carpenter, "We found no evidence that
larger or more politically active pharmaceutical firms fared
better in the review process after PDUFA was enacted. In fact,
approval times may have declined less rapidly for firms with
larger sales, even as FDA staff resources grew."
While the source of the funding for additional staff doesn't
appear to affect the speed of the review process, some critics
have faulted the industry fee program for allegedly
compromising the FDA's independence in other ways, or for
speeding up approvals so much that dangerous side effects are
overlooked. Effects beyond approval time, such as the quality
of review or the number of recalls among the drugs that
received approval, were not studied for the current report.
The study was motivated by several high-profile critiques of
the PDUFA system, including allegations that the FDA had
become a "servant of industry." Soon after the
interdisciplinary team was assembled, the researchers realized
that the effect of PDUFA on approval times -- and especially
on approval times for drugs from major companies -- could be
rigorously measured. They gathered data from publicly
available sources, and analyzed it using several computer
models.
The product is the first study that incorporates not only drug
approval times and FDA staffing levels, but also rejected
drugs, and characteristics of both the drugs and the companies
that make them. The authors used three separate models to
evaluate how approval times were changing before PDUFA took
effect, to look for any shift in approval times after PDUFA,
and to look at effects correlated to the submitting company's
total sales, lobbying budgets, and number of previous New Drug
Application submissions.
Overall, the results showed no major effect from PDUFA on
top of what was already under way when PDUFA was passed, and
no extra-rapid decrease in approval times for drugs from
larger companies that pay the largest fees. As a result,
the authors say the findings cast doubt on claims that PDUFA
benefited more powerful firms disproportionately, or that the
user fees directly promote industry influence on the drug
approval process.
But their findings also call into question the industry's
claims that PDUFA and its user fees are directly responsible
for the ongoing decrease in drug approval times. "We
strongly believe that nearly all of the decrease in approval
times would have been achieved had the FDA been appropriated
these funds directly, instead of relying on industry user
fees," says co-author Michael Chernew, Ph.D., a health
economist from the U-M School of Public Health. "And,
such an appropriation would have avoided the suspicion of
industry influence on drug approvals that has surrounded the
FDA ever since."
In addition to Fendrick, Carpenter and Chernew, the study's
authors include Dean G. Smith, Ph.D., of the U-M School of
Public Health. The study was not supported in any way by
pharmaceutical industry or FDA sources.
###
Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan Health System
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