Aug. 28 (Bloomberg) -- The U.S. Food and Drug
Administration's outside advisory panels typically serve as
"rubber stamps" for companies seeking approval of drugs and
medical devices, according to a nonprofit research group.
Eleven randomly selected FDA advisory committees recommended
approval in 79 percent of their votes on applications between
1998 and 2005, according to the study released today by the
Washington-based National Research Center for Women & Families.
The committees considered 89 products during that period.
"Some of the committees have never met a product they don't
like," said Diana Zuckerman, president of the group, said in a
telephone interview. "From a consumer point of view, this is not
good news."
Members of Congress including Senator Charles Grassley, an
Iowa Republican, have criticized the FDA for failing to
sufficiently scrutinize drug safety. Public interest groups and
lawmakers also have said the FDA has appointed doctors and
scientists to advisory committees who have financial or other
relationships with the companies whose products they consider.
The FDA said in July that it plans to write new guidelines
specifying when scientists and doctors serving on the panels
should be disqualified because of conflicts of interest. Under
FDA rules, the agency can grant waivers for those with conflicts,
allowing them to serve on panels.
The FDA convenes the committees to provide advice when the
agency has questions on applications to clear new drugs or
medical devices or additional uses for products already sold. The
agency, while not bound by the recommendations, often follows the
panels' advice.
FDA Clearance
The center's report found that "even lopsided votes against
approval apparently do not have much weight, since the FDA
subsequently approved many of those products."
The agency's decisions "are made on the totality of the
scientific data," said FDA spokeswoman Kathleen Quinn. "While
this includes the recommendations made by the advisory
committees, it is not the only thing and therefore does not
automatically guarantee an approval decision."
The research center randomly selected six of 16 drug
advisory committees and five of 18 medical-device committees. The
products considered during that time included drugs for arthritis
and erectile dysfunction and devices for laser eye surgery and
improving the accuracy of mammograms, the study said.
The device panels recommended approval 82 percent of the
time compared with 76 percent for drug-review panels, the study
found. Some committees were more likely to suggest approval than
others, ranging from 50 percent for the committee that reviews
reproductive drugs to 100 percent for the panel dealing with
arthritis medications.
Rejections Overturned
Of 38 drugs recommended by the advisory committees, the FDA
later approved all of them except one whose application was
withdrawn before the agency made its decision, the study said.
The agency approved four of 11 drugs that advisory panels
recommended rejecting, according to the findings.
"Many of today's FDA drug and device advisory committees
are rubber stamps for approval almost every time they meet," the
study said. "Even when an overwhelming majority recommended
'non-approval,' there is a good chance that FDA officials will
approve the product anyway."
The study said that during some meetings, panel members
described pressure "to conform and please colleagues" by voting
in favor of a product. The report quoted from some advisory
meetings in which panel members expressed concerns about drugs
and voted for approval anyway.
"Consumers are harmed if those advisers are pressured,
directly or indirectly, to recommend approval when they are
uncertain if a product is truly safe or effective," said
Representative Rosa DeLauro, a Democrat from Connecticut, in a
statement issued by the research center. "And when the advisory
panels oppose approval, the FDA should take those warnings
seriously."
The report said the FDA should stop granting waivers for
panel members with conflicts-of-interest and that the agency
should be more responsive to members' concerns.
--Editor: Gienger
To contact the reporter on this story:
Justin Blum in Washington at (1) (202) 624-1861 or
jblum4@bloomberg.net.
