§379d–1 Conflicts of Interest

Summary

Requires the FDA Secretary to find and pick expert members for advisory committees and to be open about money or ties that might affect their advice. Advisory committee = a group that gives advice to the FDA. Financial interest = a money or financial tie covered by 18 U.S.C. 208. The Secretary must reach out to universities, medical and scientific groups, patient groups, and others. Every 180 days the Secretary must ask for referrals from product makers, patient and disease groups, professional and medical societies, academic groups, and government organizations. The FDA can advertise at conferences, share contact info widely online, and set up a way for people funded by NIH, AHRQ, CDC, or the VA to suggest nominees. The goal is to get current expert advice and to consider how active each committee is and how many openings it has. If a member has a financial interest that needs a written decision under 18 U.S.C. 208, the FDA must post online the type, size, and reason for that decision and why the expert is needed at least 15 days before the meeting, except for information that must stay private. If the interest is found less than 30 days before the meeting, the FDA must post the information as soon as it can but no later than the meeting. The meeting record must include these disclosures. By February 1 each year the Secretary must send Congress a report about the previous fiscal year (ended September 30) with counts of nominees, those willing to serve, vacancies, people who did not serve because of potential disqualifying financial interests, people who did not serve for other reasons, meeting attendees, and the total number of disclosures and the percent of people for whom disclosures did not apply; the FDA must make that report public within 30 days. The Secretary must review and update FDA guidance about conflicts and use of 18 U.S.C. 208 at least once every 5 years, and must publish guidance on how disclosed but non-disqualifying interests are reviewed.