Monday, March 26, 2007

FDA to Reduce Conflict of Interest

The FDA uses medical experts on its advisory committees who make recommendations on whether or not to approve potentially dangerous drugs and medical devices. While it is a great idea to get advice from experts, there is a problem. Many of their experts have a significant financial incentive for recommending either for or against a product, constituting a conflict of interest.

On March 21, the FDA announced proposed rules meant to reduce this conflict of interest. Right now, experts who have no more than $100,000 or 15% of their net worth invested in pharmaceutical companies are allowed to participate in the discussions and to vote on whether to recommend what may possibly be a dangerous drug or product.

The proposed rules would reduce the amount of money to less than a $50,000 financial interest in pharmaceutical companies, and even those who fall under this limit will only be allowed to participate in the discussions. They will not be allowed to vote on recommendations.

This could mean that a significant portion of experts who now sit on these committees will be disqualified. However, there will be exceptions to this rule. Those who have over a $50,000 financial interest may sometimes obtain a special waiver from the FDA commissioner to participate.

For more information on the FDA and product recalls, feel free to surf our product liability pages by clicking here.

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