End Conflicts on FDA Approvals

posted on:
August 14, 2007

author:
Staff

 In the coming weeks, the U.S. House and Senate will have to reconcile bills they passed that give the Food and Drug Administration more money and authority to guarantee the safety of prescription drugs. The legislation is needed. There have been repeated instances where unsafe drugs have remained on the market and safety concerns of FDA scientists have been ignored. 

U.S. Sen. Christopher Dodd, D-Conn., supports the overall legislation. But in May, he voted with 41 Republicans to kill an amendment to limit financial conflicts of interest among scientists on FDA drug advisory panels.

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The Senate amendment would have allowed the FDA to grant only one waiver of a financial conflict of interest at a meeting of an advisory committee. In June, the House approved an amendment that completely eliminates the granting of waivers.

The FDA has proposed barring from voting all advisory committee members with conflicts and allowing those with a financial interest of less than $50,000 to take part in discussions about approval of that company's products.

There are obvious and dangerous pitfalls of allowing physicians and researchers with financial ties to a drug company, such as a research grant, to advise on whether the company's drugs are approved or are safe.

Of the 32 scientists on the 2005 committee that decided COX-2 inhibitors, including Vioxx, were safe, 10 had a financial ties to the drugs' makers. If these scientists had been barred from voting, two of the three drugs considered would have been rejected. Vioxx was voluntarily withdrawn after research became public that it doubled the possibility of stroke or heart attack.

Dodd voted against the amendment limiting the number of waivers for conflicts of interest because it would "further complicate an already small pool of qualified individuals in fields such as pediatrics."

However, as the Center for Science in the Public Interest points out, it should be possible to find qualified experts without financial conflicts that may color their views among the 123,000 faculty members at the 125 medical schools in the United States and the public health experts at federal agencies, including the Veterans Administration and the Centers for Disease Control. The National Institutes of Health's Office of Medical Applications of Research prohibits scientists with financial conflicts from being members of panels that evaluate the results of clinical drug trials.

Even the FDA's own proposal goes further than Dodd to ensure drug safety.

Dodd will serve on the conference committee that resolves the House and Senate versions of the bill. The legislation that emerges from those negotiations should keep the House amendment that eliminates financial conflicts of interest from FDA drug safety reviews.

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