21 USC 379d-1 - Conflicts of interest

U.S Code last checked for updates: Nov 22, 2024

§ 379d–1.

Conflicts of interest

(a)

Definitions

For purposes of this section:

(1)

Advisory committee

(2)

Financial interest

(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

(c)

Disclosure of determinations and certifications

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

(1)

15 or more days in advance

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)

Less than 30 days in advance

(d)

Public record

(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)

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

(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

(f)

Periodic review of guidance

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)

Guidance on reported disclosed financial interest or involvement

(June 25, 1938, ch. 675, § 712, as added Pub. L. 110–85, title VII, § 701(a), Sept. 27, 2007, 121 Stat. 900; amended Pub. L. 112–144, title XI, § 1142(a), July 9, 2012, 126 Stat. 1127; Pub. L. 114–255, div. A, title III, § 3101(a)(2)(U), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 117–286, § 4(a)(159), (c)(29), Dec. 27, 2022, 136 Stat. 4323, 4357.)

cite as: 21 USC 379d-1