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FDA to Limit
Influence of Outside Experts with Industry Ties
Thursday, 22 March 2007
Written by T. Maher
of outside experts with industry ties will be limited when it comes to
recommending approval of a new drug or medical device, the US Food and
Drug Administration (FDA) announced yesterday. The FDA hires medical
experts to serve on advisory panels that advise the agency on how to
proceed with any new drug.
most of these experts have financial conflicts and are often paid by
drug companies. They are unable to give an unbiased view, due to which
the FDA has faced severe criticism from all quarters. The advisory
committees are vital links between the FDA and the public. They serve
to recommend new drugs, diagnostic tests and medical devices for
approval. The FDA almost always follows the recommendations issued by
these advisory panels.
doctors and scientists who are members of these panels are often
targeted by pharmaceutical companies which try to exert undue influence
on them. Over the years instances of advisory panel members who
received lavish treatment from drug companies have tarnished the FDA's
the agency had proposed several new guidelines defining the role of
outside experts with known ties to drug makers on FDA advisory panels.
had promised to look at making the whole process transparent and send
information on the advisory panels to public groups. Additionally the
agency said it would be providing electronic notifications through an
FDA advisory committee list and posting on the FDA web site.
up on these guidelines, the FDA said yesterday any scientist or
physician who has received $50,000 in funds from any drug maker over
the last 12 months would be disqualified from advisory panels that
evaluate the said company's products.
or doctors who received less than $50,000 would be allowed to
participate in the discussions, but would not be eligible to vote.
Prevailing rules automatically disbar experts who have either received
$100,000 from drug companies or account for at least 15% of their net
F.D.A. acting deputy commissioner, Randall
W. Lutter said a “significant number” of the current advisers on FDA
panels would be affected by this rule. “The $50,000 threshold is
something that we think strikes an appropriate balance," he said. "We
are committed to making the process even stronger and
situation as regards influential experts on advisory panels had invited
Congressional ire as well. Last April a Government Accountability
Office report suggested FDA was doing an inadequate job in ensuring the
safety of drugs it approved.
report said this inadequacy was clearly visible in the way the agency
handled safety issues concerning the cholesterol-lowering drug Baycol,
the painkiller Bextra, the rheumatoid arthritis drug Arava, and the
heartburn drug Propulsid.
The New York Times cited the example of
how money influenced 10 of the 32 advisers on FDA panels voted to allow
Bextra to remain on the market and recommended re-inclusion of Merck's
painkiller Vioxx. It emerged later the drug companies had paid these
advisers to vote for them. But it must be noted that Vioxx and Bextra
continue to be barred from the market.
said the agency was committed to making the advisory committee process
more rigorous and transparent, "Today's draft guidance document should
provide more consistency in the consideration of who is eligible to
participate in advisory committee meetings and would simplify the
process," he added.
guidelines are also the first major changes made FDA Commissioner by
Dr. Andrew C. von Eschenbach since he was confirmed last year.
to the new guidelines were mixed. Representative Maurice D. Hinchey,
Democrat of New York said it was high time the FDA cleaned up its act,
“So many lives have been lost as a result of the failure of the F.D.A.
to review drugs properly,” he said. “The F.D.A. is now moving back to
where it was supposed to be, a principled agency that protects the
Lurie of Public Citizen, an advocacy group felt the new rules would
mean recommendations were based on quality alone, “I think it’s likely
to improve the quality of the recommendations, remove the taint of the
recommendations and improve the credibility of the recommendations,”
Dr. Lurie said.
Diana Zuckerman, president of the National Research Center for Women
& Families was unhappy with the $50,000 threshold, "Think of
all the members of Congress who have gotten into trouble for much
less," she said. "People do crazy things for a lot less than $50,000 —
including people who earn a lot of money."
rules are open for public comment for 60 days before being put into
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