Public Citizen Calls For End of Industry Influence on FDA Advisory Councils
The prominent consumer advocacy group Public Citizen indicates that former FDA advisory committee members who now work for corporate interests should not be allowed to speak before the same committees they used to sit on to try and influence votes.
In a letter sent to the FDA (PDF) earlier this month, officials with Public Citizen said the FDA advisory committees have a “revolving door” that allows advisors to leave the panel to work with the industry and then quickly return to speak with their former colleagues and friends to win votes in favor of products sold by their new employer.
The group warns that the agency needs to crack down on what appears to be influence peddling, which could harm the legitimacy of the advisory committee structure.
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In at least one case, a doctor who had long served on an advisory committee for 17 years came back two months after leaving to speak as a sponsor for Novartis, obtaining permission from the FDA to do so.
“Episodes such as this are concerning as they create, at least, the appearance of a conflict of interest and may bias committee members’ view of a product advocated for by one of their recent or current committee colleagues,” the letter states. “Such a revolving door thus threatens to undermine the objectivity of the FDA’s advisory committee process, which typically plays a singularly important role in influencing agency decisions regarding drug and medical device approvals and withdrawals.”
The FDA advisory committees are designed to be independent panels whose meetings, agendas and the questions raised are directed by the FDA. They are made of a number of independent experts from various disciplines, and are not FDA employees. While their recommendations are not binding, the outcomes of Panel meetings often have a significant influence on FDA regulatory decisions.
Sitting Members Also Face Conflict-of-Interest Concerns
The letter comes at the same time as the latest issue of Milbank Quarterly includes a study that finds likely bias among FDA advisors currently serving on the panels with industry ties.
The study found that individuals with financial ties to a drug company were almost 50% more likely to vote in favor of that company than those with no financial ties. The researchers also found that the bias disappeared if the individual had financial ties to a number of different firms at once.
When a drug comes up for review by the CDER advisory committee, the study indicates that an average of 13% of the committee’s members have a financial tie to the drug manufacturer. At the actual meetings, about half have at least one member at the meeting with a financial interest in the company sponsoring the drug.
In December 2011, the FDA convened an advisory committee panel to discuss the risks of Bayer’s Yaz and Yasmin birth control pills that brought protests from consumer watchdog groups and women’s health organizations after it was revealed that four members of the committee had conflicts of interest, having worked as consultants or researched for Bayer.
The committee voted 15 to 11 to decide that the drugs, linked to high rates of blood clot-related illnesses, had benefits that out-weighed the risks; a margin of four votes.
“It is imperative that the FDA develop, articulate, and implement a written policy applicable to all voting advisory committee members that restricts these revolving-door arrangements, which undermine public confidence in FDA advisory committees and in the agency itself,” Public Citizen officials wrote. “We urge the FDA to issue a guidance document outlining clear restrictions on current, former, and prospective committee members’ speaking and consulting arrangements on behalf of sponsors before FDA advisory committees.”
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