- March 31 - A new report from the U.S. Department of Health and
Human Services (HHS) Inspector General confirms that the
federal governments current drug review process does not
adequately protect consumers from harmful prescription medications,
Public Citizen said today. Seven drugs approved since 1996, including
Rezulin and Redux (used to treat diabetes and obesity) have been
removed from the market because they were deemed unsafe.
to the report, 40 percent of U.S. Food and Drug Administration
(FDA) long-term reviewers responding to a survey conducted by
the Inspector General said that the review process has worsened
since they were first employed at the agency. The report recommends
that in most circumstances, the permitted review period for
new drugs, which ranges between six and 12 months, be extended
by one to two months.
drugs must be reviewed for safety and efficacy before being
put on the market. Under legislation that took effect in 1992,
drug companies pay "user fees," essentially paying
the salaries of the people reviewing the drugs.
FDA is supposed to rigorously screen all new drugs and ensure
that they are safe and effective before they are sold to millions
of people," said Peter Lurie, M.D., MPH, deputy director
of Public Citizens Health Research Group. "Unless
the agency gets out of the snug bed it is currently sharing
with industry, unsafe drugs will continue to slip through the
of the Inspector Generals report is a survey of 401 new
drug reviewers in the FDAs Center for Drug Evaluation
and Research. Fifty-eight percent said that the six months allotted
for review of priority New Drug Applications was inadequate;
25 percent felt similarly about the target of 10 months provided
for review of most standard applications. A priority drug is
a breakthrough drug or one designed to treat an unusual condition;
a minority of drugs fall into this category.
percent of these physicians and scientists felt pressure to
recommend that drugs be approved for sale despite their reservations
about the drugs safety, efficacy or quality. (The report
does not say who exerted the pressure.) The report concludes:
"Overall, these findings present a significant warning
are consistent with prior research conducted by Public Citizen
and the FDA itself. In December 1998, Public Citizen conducted
a study (click
here to view) showing that 19 FDA medical officers identified
27 new drugs that they had reviewed in the past three years
that they thought should not be approved but the agency approved
anyway. Seventeen medical officers described the current standards
of FDA review for safety and efficacy as "lower" or
"much lower" compared to those in existence prior
to 1995. And several medical officers said they had been instructed
by their superiors to censor their reports or presentations.
FDA survey in 2001 precipitated by high turnover rates among
employees in the agency showed that about one-third of medical
officers did not feel comfortable expressing differing scientific
opinions, and a similar number felt that decisions adverse to
a drug were stigmatized within the agency. A number of reviewers
said that decisions should be based more on science and less
on corporate wishes.
climate was confirmed in the new Inspector Generals report.
Twenty-one percent of those polled indicated that the work environment
at the FDA allowed for scientific disagreement to only a small
or no extent. The report also indicates that, over time, a lower
percentage of drugs, particularly priority drugs, is being presented
to the FDAs external advisory committees, reflecting the
speed-up at the FDA and minimizing the opportunity for valuable
external peer review.
reliance on user fees from the industry has skewed the drug
approval process toward the industrys financial interests
and away from consumer protection," Lurie said. "Only
a purely government-funded agency, as the FDA had been from
its origins in 1906 to 1992, can have the independence necessary
to keep unsafe and/or ineffective drugs off the market."
here to view the report, FDAs Review Process for New
Drug Applications: A Management Review (OEI-01-01-00590).