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  • BIOETHICS FORUM ESSAY

Ethics at the FDA (cont.)

Readers will recall that the committees are supposed to provide expert advice from diverse perspectives regarding the safety and efficacy of new drugs and medical devices. According to an FDA official, the committees “lend credibility to the FDA decision-making processes by having public discussions of controversial topics.”

This credibility may be misplaced. Using meeting transcripts that FDA conveniently posts on the Internet, the National Research Center for Women & Families conducted an analysis of the discussions, voting patterns, and outcomes of a large sample of advisory committee meetings. The results of this analysis are disturbing.

As summarized by Diana Zuckerman, the report’s author, the study found that committee members usually recommend approval “even if they have strong concerns about the products’ safety and effectiveness, and on those rare occasions when the committee opposes approval, the FDA frequently approves the product anyway.”

There’s more:

The overwhelming pattern of unanimous approval recommendations sheds light on previous studies indicating that most committees have at least one member with a financial tie to the company whose product is under review. “Our study indicates that even one committee member with a financial conflict of interest could easily influence the votes of the entire committee, and thus the FDA decision to approve the product,” said Zuckerman.

The study also found that committee members often explicitly questioned whether the products were safe or effective, but described peer pressure and other pressures to approve them despite their concerns. FDA transcripts indicate that FDA officials almost never respond to those comments or concerns, which is likely to be interpreted as acquiescence.

The FDA subsequently approves virtually every product recommended for approval, apparently unconcerned about the doubts expressed, and often ignoring the post-market study requirements and other “conditions of approval” that committee members recommend as safeguards.

“It is not possible to know what the rate of approval ‘should’ be, but the study results are worrisome. The percentage of approval recommendations is very high, the percentage of unanimous approvals is very high, and advisory committee members are regularly admitting that they vote for approval despite serious misgivings about safety or effectiveness,” Zuckerman notes.

– Michael Yesley

Published on: November 16, 2006
Published in: Conflicts of Interest in Research, Emerging Biotechnology, Science and Society

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