Last year, Public Citizen, a national non-profit public interest organization, exposed that while conflicts of interest at the FDA's drug advisory committees are common and often have serious dollars at stake, advisory committee members and voting consultants rarely step down because of them. If a new conflict-of-interest amendment by Congressman Maurice Hinchey, D-NY, goes through, this will soon change for the better.
The foundation of the American drug approval process is theoretically objective science; however, the very nature of the process often allows subjectivity to come into play. In order for a new pharmaceutical to be approved by the FDA, the Center for Drug Evaluation and Research (CDER) looks at the pre-approval clinical trials paid for by the drug's maker and determines whether the drug is safe and effective. This is done at a rate of 25 to 30 new pharmaceutical drugs per year, according to Public Citizen.
The CDER often relies on advice from external advisory committee members and voting consultants, who are invited by the FDA to make the decisions. According to Public Citizen, this is where the problem is.
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Conflicts of interest at the FDA are rampant and largely ignored
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