BEIJING, July 24 (Xinhuanet) -- The U.S. Food
and Drug Administration (FDA) announced Monday that it plans to specify in
its new guidelines the kind of industry ties permitted for the
outside scientists and doctors serving on its advisory board.
According to Bloomberg report, the FDA is
considering to make advisory committee members' financial situation more
transparent to the public. The advisory board has the power to make
recommendations to the FDA on permitting drugs and
medical devices to go on market, thus its votes can have enormous
influence on drug company stock prices.
The FDA has long been criticized for appointing
doctors and scientists who have such deep financial ties to drug makers that
their advice is tainted. The U.S. House has approved legislation that seeks to
prevent the FDA from allowing those with conflicts to serve on advisory
The new guidelines, which are being debated
internally and will have to go through a public comment period, are an effort to
codify how the FDA grants “waivers,” which allow experts with financial
ties to drug makers to serve on the boards.
FDA officials said the rules would make it all but
impossible for experts who get money from drug makers’ marketing departments to
serve on advisory committees. That would exclude, for instance, anyone who is
paid by the marketing departments to promote drugs.
But the rules would loosen other restrictions, they
said. Experts whose ties to a drug maker involve only a grant made to their
university may not need to get a waiver, they said.
Indeed, agency officials said they had no intention
of excluding all advisers with ties to drug makers.
“There are very few academic experts engaged in
research who don’t have some ties to industry,” said Dr. Scott Gottlieb, deputy
commissioner for medical and scientific affairs at the FDA.
Gottlieb told reporters that he plans to say in
remarks at a panel discussion in Washington that the House legislation
would create problems for the FDA. In a draft of his speech, Gottlieb says the
measure might hamper the agency's ability to "put experience and expertise as
the paramount criteria when recruiting members to serve on these
However, critics contend that the agency must do a
better job of keeping its advisory boards free from the drug industry’s
financial influence, and studies show that conflicts of interests do exist.
A study published in the April 26 Journal of the
American Medical Association found that 28 percent of advisory board
members and consultants had a financial link to either a drugmaker whose product
was being considered or a competitor. The most common ties were payments for
consulting, grants or investments, according to the study by Public Citizen, a
Washington-based group that is critical of the FDA's oversight.
A February 2005 analysis by the Center for Science in
the Public Interest, another Washington-based group critical of the FDA, found
that 10 of 32 advisory panelists considering the safety of a class of pain
medications similar to Merck & Co.'s withdrawn Vioxx had financial ties to
the drugs' makers.
Had those panelists been excluded, the advisory
committee's recommendation to leave the products on the market would have been
reversed, the study found. Enditem