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

(a)

Definitions

For purposes of this section:

(1)

Advisory committee

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)

Financial interest

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

(b)

Recruitment for advisory committees

(1)

In general

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)

Recruitment activities

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)

Expertise

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

(c)

Disclosure of determinations and certifications

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

(1)

15 or more days in advance

section 208(b)(1) of title 18 section 552a of title 5As 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 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 (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)

Less than 30 days in advance

section 208(b)(1) of title 18In 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 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)

Public record

section 552 of title 5 section 552a of title 5The 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 and ).

(e)

Annual report

(1)

In general

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)

section 208 of title 18 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 ;

(B)

section 208 of title 18 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 ;

(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)

Public availability

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)

Periodic review of guidance

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

(1)

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

Guidance on reported disclosed financial interest or involvement

section 208 of title 18The 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 for the purposes of participating in a particular matter.

June 25, 1938, ch. 675, § 712 Pub. L. 110–85, title VII, § 701(a)Sept. 27, 2007121 Stat. 900 Pub. L. 112–144, title XI, § 1142(a)July 9, 2012126 Stat. 1127 Pub. L. 114–255, div. A, title III, § 3101(a)(2)(U)Dec. 13, 2016130 Stat. 1155 Pub. L. 117–286, § 4(a)(159)Dec. 27, 2022136 Stat. 4323(, as added , , ; amended , , ; , , ; , (c)(29), , , 4357.)

Editorial Notes

References in Text

Pub. L. 93–579Dec. 31, 197488 Stat. 1896 section 552a of Title 5 section 552a of Title 5 section 552a of Title 5The Privacy Act of 1974, referred to in subsec. (c)(3)(A), is , , , which enacted , Government Organization and Employees, and provisions set out as notes under . For complete classification of this Act to the Code, see Short Title of 1974 Amendment note set out under and Tables.

Prior Provisions

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

Amendments

Pub. L. 117–286, § 4(a)(159)2022—Subsec. (a)(1). , substituted “chapter 10 of title 5” for “the Federal Advisory Committee Act”.

Pub. L. 117–286, § 4(c)(29)section 13109(a)(2) of title 5Subsec. (c). , substituted “,” for “section 107(a)(2) of the Ethics in Government Act of 1978,”.

Pub. L. 114–2552016—Subsec. (e)(1)(B). substituted “service as members” for “services as members”.

Pub. L. 112–144, § 1142(a)(1)2012—Subsecs. (b), (c). , 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.

Pub. L. 112–144, § 1142(a)(2)Subsec. (d). , substituted “subsection (c)” for “subsection (c)(3)”.

Pub. L. 112–144, § 1142(a)(3)Subsec. (e). , amended subsec. (e) generally. Prior to amendment, subsec. (e) related to annual report.

Pub. L. 112–144, § 1142(a)(4)Subsec. (f). , 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).

Pub. L. 112–144, § 1142(a)(5)Subsec. (g). , added subsec. (g).

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Pub. L. 112–144, title XI, § 1142(b)July 9, 2012126 Stat. 1130

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

, , , provided that:

Effective Date

Oct. 1, 2007section 701(c) of Pub. L. 110–85 section 355 of this titleSection effective , see , set out as an Effective Date of 2007 Amendment note under .