FDA Announces New Policies to Improve Transparency and Public Disclosure for Advisory Committees
On Monday, the Food and Drug Administration (FDA) formally announced new policies intended to increase transparency and public disclosure for its advisory committees. Although a number of new policies were announced, the one creating the most buzz is the policy barring an advisor from participating in a meeting if the FDA determines that he or she has a financial interest of more than $50,000. If the financial interest is less than $50,000, a waiver may be granted, but only if FDA officials "determine that there is an essential need for the advisor's particular expertise."
According to the FDA's press release, a financial interest would include "grants, stock holdings and contracts with a company that would be affected by the committee's recommendations." A more detailed description can be found in the final guidance document.
The new policies are almost surely a result of the increased scrutiny of FDA advisory committees by the public and Congress. The public outcry has been fueled by recent scandals in which members of FDA advisory committees vote to recommend drugs that they have a financial interest in, even when those drugs are likely to be harmful.
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