November 17, 2007

FDA’s New Proposals to Deal With Conflicts of Interest Are Bittersweet for Breast Implant Safety Advocates

Filed under: Breast Implants, FDA, News — Sybil @ 12:59 am

This story on the AP wire shows some progress at the FDA. Sadly, it is too late for the issue of breast implants. Many members of the FDA panel that approved implants clearly had conflicts of interest, including one who took money from the manufacturers to make a cd extolling the virtues of breast implants. Sometimes doing the right thing is better late than never, but with the approval of implants anything the FDA does about the disclosure of conflicts of interest is at this point too little and too late.

These are the proposed changes:

1) The experts will have to disclose any financial ties to the industry under review.

2) Experts on the advisory committees will have to fill out a form disclosing the potential conflicts and explaining why they should still be able to advise the agency.

3) If the FDA agrees to a waiver, the disclosure form will be posted on the FDA’s Web site, typically at least 15 days before the committee meets.

A 2006 study found that more than one-fourth of the experts relied on for advice on drugs, including whether to approve new pharmaceuticals, has a financial conflict. The FDA says a ban on all outside reviewers with potential conflicts is impractical because so many scientists whose expertise the government relies on have ties to industries under FDA regulation. While the FDA is not required to follow the recommendations of such outside advisers, usually does.

The proposed rules are open for public comment for 60 days before the FDA makes a decision whether to revise or adopt them.

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