FDA tightens conflict-of-interest rules for advisers

The FDA has finalized new rules designed to screen out potential advisers if they or their family members have financial interests that conflict with their role in the process. Among other things, the new rules will prevent participation of an expert in advisory decisions if that person, their spouse or minor child has conflicting financial interests of more than $50,000. Until now, the FDA has screened committee members, but has sometimes given advisers with such conflicts a waiver allowing them to participate nonetheless.

Going forward, the FDA is unlikely to offer a waiver if the potential adviser or family member has interests falling above $50,000, and will avoid offering waivers for those with interests under $50,000 only if the FDA decides that the adviser's special expertise is needed. Generally speaking, however, the agency's officials want to cut back on issuing waivers.

To make sure it reaches enough qualified and unbiased advisers during their next round of recruiting, the agency has contacted almost 280 professional organizations, published six Federal Register notices on the subject and has attended a number of professional meetings. To date, these efforts have resulted in the FDA receiving 350 resumes, officials said.

To learn more about the FDA's plans:
- read this Wall Street Journal blog item

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