§379d–1 — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary must make sure the FDA gets expert advice by finding and recruiting people for FDA advisory committees. Advisory committee means a group that gives advice to the Secretary under federal rules. Financial interest means the kind of money or benefit covered by section 208(a) of title 18. The Secretary must create outreach plans, ask medical and scientific groups for help, and request referrals at least every 180 days from product makers, patient groups, professional and academic organizations, and government groups. Recruitment can include ads at conferences, widely sharing the FDA contact for nominations, and a way for people funded by NIH, AHRQ, CDC, or the Veterans Health Administration to suggest candidates. The Secretary must consider how busy each committee is and how many open spots there are. When a member has a financial interest and the Secretary makes a written waiver or certification under section 208(b)(1) or 208(b)(3) of title 18, the FDA must post on its website the type, size, and nature of that interest and the Secretary’s reasons for the decision. That information must be posted as soon as practicable but normally no later than 15 days before the committee meeting, except for records protected by the Freedom of Information Act or the Privacy Act; if the interest is learned less than 30 days before the meeting, it must be posted as soon as practical but no later than the meeting. The meeting record and transcript must include the same disclosure. By February 1 each year the Secretary must send a report to the Senate Committees on Appropriations and on Health, Education, Labor, and Pensions and to the House Committees on Appropriations and on Energy and Commerce with counts about nominations, vacancies, declines (including those who declined because of potential disqualifying interests), attendance, and the number and percentage of disclosures; the report must be made public within 30 days. At least every 5 years the Secretary must review and update FDA guidance on conflicts of interest and must issue guidance explaining how disclosed but non‑disqualifying interests are handled.

Title 21, §379d–1

Food and Drugs — Source: USLM XML via OLRC

(a)For purposes of this section:

(1)The term “advisory committee” means an advisory committee under chapter 10 of title 5 that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.

(2)The term “financial interest” means a financial interest under section 208(a) of title 18.

(b)(1)The Secretary shall—

(A)develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups;

(B)seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities;

(C)at least every 180 days, request referrals for potential members of advisory committees from a variety of stakeholders, including—

(i)product developers, patient groups, and disease advocacy organizations; and

(ii)relevant—

(I)professional societies;

(II)medical societies;

(III)academic organizations; and

(IV)governmental organizations; and

(D)in carrying out subparagraphs (A) and (B), take into account the levels of activity (including the numbers of annual meetings) and the numbers of vacancies of the advisory committees.

(2)The recruitment activities under paragraph (1) may include—

(A)advertising the process for becoming an advisory committee member at medical and scientific society conferences;

(B)making widely available, including by using existing electronic communications channels, the contact information for the Food and Drug Administration point of contact regarding advisory committee nominations; and

(C)developing a method through which an entity receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person whom the Food and Drug Administration can contact regarding the nomination of individuals to serve on advisory committees.

(3)In carrying out this subsection, the Secretary shall seek to ensure that the Secretary has access to the most current expert advice.

(c)Notwithstanding section 13109(a)(2) of title 5, the following shall apply:

(1)As soon as practicable, but (except as provided in paragraph (2)) not later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18 or a written certification as referred to in section 208(b)(3) of such title, applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 or section 552a of title 5 (popularly known as the Freedom of Information Act and the Privacy Act of 1974, respectively)) on the Internet Web site of the Food and Drug Administration—

(A)the type, nature, and magnitude of the financial interests of the advisory committee member to which such determination or certification applies; and

(B)the reasons of the Secretary for such determination or certification, including, as appropriate, the public health interest in having the expertise of the member with respect to the particular matter before the advisory committee.

(2)In the case of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18 or a written certification as referred to in section 208(b)(3) of such title applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 or 552a of title 5) on the Internet Web site of the Food and Drug Administration, the information described in subparagraphs (A) and (B) of paragraph (1) as soon as practicable after the Secretary makes such determination or certification, but in no case later than the date of such meeting.

(d)The Secretary shall ensure that the public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c) (other than information exempted from disclosure under section 552 of title 5 and section 552a of title 5).

(e)(1)Not later than February 1 of each year, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives, a report that describes—

(A)with respect to the fiscal year that ended on September 30 of the previous year, the number of persons nominated for participation at meetings for each advisory committee, the number of persons so nominated, and willing to serve, the number of vacancies on each advisory committee, and the number of persons contacted for service as members on each advisory committee meeting for each advisory committee who did not participate because of the potential for such participation to constitute a disqualifying financial interest under section 208 of title 18;

(B)with respect to such year, the number of persons contacted for service as members for each advisory committee meeting for each advisory committee who did not participate because of reasons other than the potential for such participation to constitute a disqualifying financial interest under section 208 of title 18;

(C)with respect to such year, the number of members attending meetings for each advisory committee; and

(D)with respect to such year, the aggregate number of disclosures required under subsection (d) and the percentage of individuals to whom such disclosures did not apply who served on such committee.

(2)Not later than 30 days after submitting any report under paragraph (1) to the committees specified in such paragraph, the Secretary shall make each such report available to the public.

(f)Not less than once every 5 years, the Secretary shall—

(1)review guidance of the Food and Drug Administration with respect to advisory committees regarding disclosure of conflicts of interest and the application of section 208 of title 18; and

(2)update such guidance as necessary to ensure that the Food and Drug Administration receives appropriate access to needed scientific expertise, with due consideration of the requirements of such section 208.

(g)The Secretary shall issue guidance that describes how the Secretary reviews the financial interests and involvement of advisory committee members that are disclosed under subsection (c) but that the Secretary determines not to meet the definition of a disqualifying interest under section 208 of title 18 for the purposes of participating in a particular matter.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Privacy Act of 1974, referred to in subsec. (c)(3)(A), is Pub. L. 93–579, Dec. 31, 1974, 88 Stat. 1896, which enacted section 552a of Title 5, Government Organization and Employees, and provisions set out as notes under section 552a of Title 5. For complete classification of this Act to the Code, see

Short Title

of 1974 Amendment note set out under section 552a of Title 5 and Tables.

Prior Provisions

A prior section 712 of act June 25, 1938, was renumbered section 711 by Pub. L. 102–571 and is classified to section 379d of this title.

Amendments

2022—Subsec. (a)(1). Pub. L. 117–286, § 4(a)(159), substituted “chapter 10 of title 5” for “the Federal Advisory Committee Act”. Subsec. (c). Pub. L. 117–286, § 4(c)(29), substituted “section 13109(a)(2) of title 5,” for “section 107(a)(2) of the Ethics in Government Act of 1978,”. 2016—Subsec. (e)(1)(B). Pub. L. 114–255 substituted “service as members” for “services as members”. 2012—Subsecs. (b), (c). Pub. L. 112–144, § 1142(a)(1), added subsecs. (b) and (c) and struck out former subsecs. (b) and (c) which related to appointments to advisory committees and disclosures, prohibitions on participation, and waivers. Subsec. (d). Pub. L. 112–144, § 1142(a)(2), substituted “subsection (c)” for “subsection (c)(3)”. Subsec. (e). Pub. L. 112–144, § 1142(a)(3), amended subsec. (e) generally. Prior to amendment, subsec. (e) related to annual report. Subsec. (f). Pub. L. 112–144, § 1142(a)(4), substituted “shall—” for “shall review guidance of the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory committees and update such guidance as necessary.” and added pars. (1) and (2). Subsec. (g). Pub. L. 112–144, § 1142(a)(5), added subsec. (g).

Statutory Notes and Related Subsidiaries

Effective Date

of 2012 Amendment Pub. L. 112–144, title XI, § 1142(b), July 9, 2012, 126 Stat. 1130, provided that: “The

Amendments

made by subsection (a) [amending this section] apply beginning on October 1, 2012.”

Effective Date

Section effective Oct. 1, 2007, see section 701(c) of Pub. L. 110–85, set out as an

Effective Date

of 2007 Amendment note under section 355 of this title.

§379d–1 Conflicts of interest

Summary

Title 21, §379d–1

Notes & Related Subsidiaries

Editorial Notes

References in Text

Short Title

Prior Provisions

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Amendments

Effective Date

Effective Date

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