Public Availability of Advisory Committee Member's Financial Interest Information and Waivers

Name of Guidance: Public Availability of Advisory Committee Member's Financial Interest Information and Waivers

Status of Guidance: Draft guidance

Date of Guidance: Draft dated October 2007

Name of Organizations Releasing the Guidance:

United States Department of Health and Human Services, Food and Drug Administration (FDA)

Target Audience: This guidance is intended for the general public and for government employees planning to participate as FDA advisory committee members under the Federal Advisory Committee Act (FACA).

Guidance, Laws and Regulations Referenced:

5 Code of Federal Regulations (CFR) 2634.903 (a) and (b)(3) – Executive Branch financial disclosure, general requirements, filing dates, and extensions.

5 CFR 2635.502 – Impartiality in performing official duties, personal and business relationships.

5 CFR 2640.103(a)(1) – Interpretation, exemptions, and waiver guidance concerning 18 U.S.C. 208’s general provisions.

21 CFR 14.5 - Public hearing before a public advisory committee. It addresses the purpose of proceedings before an advisory committee.

21 CFR 20 – This regulation refers to what should be disclosed as public information

41 CFR 102-3.105 and 102-3.130 – These are federal management regulations regarding advisory committee management.

5 United States Code (U.S.C.) Appendix 2 part 9 (b) – This is part of the Federal Advisory Committee Act directed to government organizations and employees. This section refers to the establishment and purpose of advisory committees, publication in the Federal Register, charter: filing, contents, and copy.

18 U.S.C. 208 (a), (b)(1), and (b)(3) – Refers to acts affecting a personal financial interest, bribery, graft, and conflicts of interest.

18 U.S.C. 712 (c) – This is a copy of the FDA advisory committee waiver.

21 U.S.C. 355 (n)(4) – This code refers to new drugs’ scientific advisory panels.

21 U.S.C. 393 – This code describes FDA’s general administration procedures.

Definitions:

Federal Advisory Committee Act (FACA) – Act created to maintain the public informed of the different government committees available, their function, membership, activities and cost.

Background:

The FDA uses advisory committees to obtain expert advice on different scientific, technical and policy matters under its supervision. In order to obtain objective recommendations, the FDA screens all advisory committee participants, their immediate family members, and business partners, for any possible conflicts of interests and for any possible behaviors that may seem unacceptable. This guidance refers to the financial information that needs to be disclosed by advisory board participants and the different waivers that can be granted by the FDA.

Summary:

The FDA has implemented agency-wide procedures for all government employees participating in advisory board committees as experts. All participants are required to disclose any possible conflict of interest. These disclosures are not made public unless the FDA decides to grant a waiver to the participant. All such waivers will be signed by the committee member and posted on the FDA’s website before the advisory meeting takes place. A roster of all committee members will also be available for public review before each committee meeting.

A copy of the “Advisory Committee Member Acknowledgement of Financial Interest” template is attached to this guidance as well as a copy of the “Waiver to Allow Participation in the Advisory Committee”.

Rationale:

The FDA has the responsibility of regulating medicines, medical devices, and food within the United States. The agency does not want to show a hint of possible impropriety and must take these extra steps to assure the public’s confidence on its dealings.

Resulting Recommendations:

• Expand the ‘conflict of interest acknowledgements’ to any non-government employees participating in advisory board meetings.

Impact:

The implementation of this guidance will increase the transparency that needs to exist between the FDA and the general public.