Healthy Skepticism Library item: 8971

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Publication type: news

Goldstein J.
FDA Tightens Conflict of Interest Rules
Wall Street Journal 2007 Mar 22Health Blog
http://blogs.wsj.com/health/2007/03/22/fda-tightens-conflict-of-interest-rules/

Full text:

Moving to fix a problem that has dogged the Food and Drug Administration for years, the agency unveiled plans to bar anyone with a conflict of interest from being a voting member of expert advisory committees.

The agency calls routinely on these boards of experts for advice on topics ranging from the approval of new drugs and devices to wrestling with safety issues for products on the market. But in tapping doctors with demonstrated expertise, the agency has enlisted many of the same people working with drug and device makers. Those conflicts corrode the authority and independence of the panels, critics say.

Under the proposed rules those with financial conflicts of as much as $50,000 would be allowed to serve on the boards as non-voting members.

The financial ties between board members and industry drew intense scrutiny in 2005, when an advisory board voted to allow Merck’s painkiller Vioxx to return to the market, and to allow Pfizer’s Bextra, a similar drug, to remain on the market, the New York Times points out. Ten of 32 board members had financial ties to the drug makers; without those board members, the votes would have gone the other way. (The FDA didn’t follow the panel’s advice.)

A study published last year in the Journal of the American Medical Association found that 28 percent of advisors and voting consultants had conflicts of interest, but only 1 percent were recused, the Los Angeles Times notes. The study did not, however, find a strong relationship between voting patterns and conflict of interest.

A story in The Journal says “the draft guidelines are the latest of several recent moves by FDA to head off criticism from members of Congress, who are now considering various bills that would affect how the agency handles drug safety and other matters.”