21 U.S.C. § 379d–1 — Conflicts of interest

This section sets rules for recruiting FDA advisory committee members and disclosing their financial conflicts of interest. (a) Definitions. (1) "Advisory committee" means an advisory committee under chapter 10 of title 5 that gives the Secretary advice or recommendations about FDA activities. (2) "Financial interest" means a financial interest as defined in section 208(a) of title 18. (b) Recruitment for advisory committees. (1) The Secretary must: (A) build and use outreach strategies to find potential advisory committee members at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups; (B) ask professional medical and scientific societies what recruitment and information methods work best; (C) at least every 180 days, ask a range of groups — including product developers, patient groups, disease advocacy organizations, and relevant professional, medical, academic, and government organizations — to suggest potential members; and (D) while doing this, take into account how active each advisory committee is (including how many meetings it holds each year) and how many seats are open. (2) Recruitment efforts may include advertising how to become an advisory committee member at medical and scientific conferences; widely sharing, including electronically, the contact information for the FDA's point of contact on advisory committee nominations; and creating a way for organizations funded by the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration to identify someone the FDA can contact about nominating members. (3) In doing all this, the Secretary must try to make sure the FDA has access to the most current expert advice available. (c) Disclosure of determinations and certifications. Despite section 13109(a)(2) of title 5: (1) Normally, and no later than 15 days before an advisory committee meeting where a written determination or certification about a member's financial interest (under section 208(b)(1) or (b)(3) of title 18) applies, the Secretary must post on the FDA's website — leaving out anything exempt from disclosure under the Freedom of Information Act or the Privacy Act — the type, nature, and size of that financial interest, and the Secretary's reasons for the determination or certification, including, where relevant, the public health value of having that member's expertise on the matter. (2) If the financial interest becomes known less than 30 days before the meeting, the Secretary must post that same information as soon as practical afterward, but no later than the meeting date. (d) Public record. The Secretary must make sure the public record and transcript of every advisory committee meeting includes the disclosure required by (c), again leaving out information exempt under the Freedom of Information Act and the Privacy Act. (e) Annual report. (1) By February 1 each year, the Secretary must report to the Senate Appropriations and Health, Education, Labor, and Pensions Committees, and the House Appropriations and Energy and Commerce Committees, on the fiscal year that ended the previous September 30. The report must cover: how many people were nominated for each advisory committee and how many were willing to serve; how many seats were vacant; how many people were not able to serve because of a disqualifying financial interest under section 208 of title 18; how many did not serve for other reasons; how many members attended each committee's meetings; and the total number of required disclosures under (d), and what percentage of members who served were not subject to them. (2) Within 30 days of sending a report to Congress, the Secretary must also make it public. (f) Periodic review of guidance. At least once every 5 years, the Secretary must review the FDA's guidance on advisory committee conflict-of-interest disclosure and how section 208 of title 18 applies, and update that guidance as needed so the FDA can still get the scientific expertise it needs, while respecting section 208's requirements. (g) Guidance on reported disclosed financial interest or involvement. The Secretary must publish guidance explaining how the Secretary reviews financial interests and involvement that advisory committee members disclose under (c), when the Secretary decides those interests do not actually count as a disqualifying interest under section 208 of title 18 for that particular matter.