Where the FDA Turns When It Needs Scientific Advice

March 21, 2012 | 4:10 pm
Francesca Grifo
Former contributor

While there’s a wealth of scientific expertise inside the FDA and other federal scientific agencies, FDA’s scientific staff often rely on the advice of experts outside the agency to help them decide whether to approve a new prescription drug or medical device, or to recall a product or issue stronger warning labels when there are safety problems.

The nearly 1,000 federal advisory committees across the federal government are supposed to be independent. The committees make science-based recommendations on topics as wide-ranging as chemical and toxin exposure limits, dietary standards, and the safety and efficacy of drugs and medical devices. At the FDA alone, there are more than 500 external scientists serving on 33 committees. One of those committees, the Medical Devices Advisory Committee, has 18 separate panels.

FDA advisory committee meeting

UCS is asking Congress to require the FDA to continue to disclose and reduce the number of waivers that are granted to scientists with financial conflicts-of-interest who serve on FDA scientific advisory committees. Photo: FDA

But sometimes, FDA advisory committee experts work for the very companies whose products the agency is supposed to assess, creating financial conflicts of interest that can lead to the approval of unsafe products and significant harm to the American public.

As I described earlier this week, the FDA’s approval of Vioxx led to thousands of premature deaths and as many as 100,000 unnecessary heart attacks. But in 2005, an FDA advisory panel voted to allow the drug to return to the market. A study conducted by the Center for Science in the Public Interest for the New York Times found that that ten of the 32 members of the advisory panel had financial conflicts with manufacturers of cox-2 inhibitors (including Vioxx), and that their votes made the difference in the panel’s decision. Fortunately, the company chose not to reintroduce the drug.

Improving advisory committees at the FDA

In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA). The new law made several improvements to drug safety at FDA by creating more transparency at the agency, requiring pharmaceutical companies to pay more for FDA review of their drugs, creating a registry of clinical trials, and granting the agency more authority to monitor drugs after they are approved.

FDAAA also beefed up the efforts the agency must make to recruit panelists who do not have conflicts of interest. First, the law requires the agency to gradually reduce the number of conflicted experts it selects. Even more importantly, when the FDA selects an expert with financial conflicts and grants that panelist a waiver to participate, the law requires the waiver to be part of the public record.

The reforms in FDAAA, coupled with the leadership of FDA Commissioner Margaret Hamburg, appear to be having an effect. A recent UCS survey of FDA scientists found that while corporate and political interference on agency scientists persists, more FDA scientists believed in 2011 that the agency is moving in the right direction compared to 2006.

Incredibly, the conflict-of-interest reforms are at risk of being eliminated, as Congress considers changes to FDAAA this year.

More work can be done

Despite this progress, conflicted experts still wield influence. For example, in 2010, FDA convened a panel to evaluate whether the diabetes drug Avandia should be recalled due to an increased risk of heart attack. The decision that would have had a significant impact on the drug’s maker, GlaxoSmithKline (GSK). One of the panelists, Dr. David Capuzzi, had served as a paid member of GSK speaker’s bureau for several years and had earned nearly $7,000 in speaking fees.

Dr. Capuzzi was one of just three members of the committee to vote for keeping Avandia on the market without any stronger warnings or restrictions. Dr. Capuzzi’s conflict was not noted by the FDA, but was uncovered only by a media investigation after the meeting occurred. These undisclosed financial conflicts weaken the public’s faith in the FDA.

UCS has advocated for additional reforms to scientific advisory panels that would further limit the ability of conflicted experts to inappropriately sway the agency’s decisions. We support a total ban on the use of experts with conflicts, except in those unique situations where the FDA is considering drugs that address rare diseases where the pool of experts is very small. UCS also has urged the FDA to screen experts more carefully for conflicts. Congress should continue the progress that has been made since 2007 by further tightening restrictions on conflicted experts.