FDA Under Fire

Reveals that there may be conflicts of interest among advisory committee members recommending approval of a drug by the United States Food and Drug Administration (FDA). Relationship of committee members with pharmaceutical corporations that have products under FDA review; How FDA look at conflicts of interest in approving drugs.

By Marc Bertucco, published on January 01, 2001

DRUGS

The Food and Drug Administration (FDA) was established in 1906 to ensure the safety, efficacy and labeling of pharmaceutical products. Today, the integrity of the FDA's approval process is in question.

A recent USA Today study reveals that there may be conflicts of interest among advisory committee members recommending FDA drug approvals. Some members are financially linked to the pharmaceutical corporations that have products under FDA review. While federal law prohibits such participation without FDA-approved waivers, they're apparently granted with alarming frequency.

The study found that in 159 advisory committee meetings between January 1998 and June 2000, 40 requests for conflict-of-interest waivers were refused, while 803 of the 1,620 attending members had been granted waivers. For instance, in the two meetings discussing Prozac and Zoloft, four of the 14 members had been issued waivers.

"We go through a waiver process for all advisory committee members and look at them in terms Of their conflicts for each and every meeting," says FDA spokesperson Susan Cruzan. "If they've worked on a specific product, they are automatically refused from the meeting. The FDA looks to balance the need for an expert versus the conflicts."

According to Dennis Cauchon, the reporter who conducted the research, the FDA is required to document conflicts and why the person's service is more important. Copies of the waiver statements are available, he says, "but if you go to the Freedom of Information Act (FOIA) office to get one, [parts of the statement] are blacked out."

USA Today is currently pushing to make these statements publicly available through the FOIA office.

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