2012-5776. Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA advisory committee members, and FDA staff, entitled “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.” We are issuing the guidance to help the public, FDA advisory committee members, and FDA staff to understand the public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The guidance provides additional transparency to FDA's advisory committee process beyond current guidance. This guidance finalizes the draft guidance of the same title dated March 2010 and replaces the guidance of the same title dated August 2008.

DATES:

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to Advisory Committee Oversight and Management Staff, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Michael Ortwerth, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5104, Silver Spring, MD 20993, email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. The Guidance

FDA is announcing the availability of a guidance entitled, “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.” FDA issues guidance documents for FDA staff, applicants and sponsors, and the public that describe the Agency's current views on a subject.

In January 2002, FDA issued draft guidance on “Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees,” and requested comments on the draft guidance (formerly Docket No. 02D-0049, now Docket No. FDA-2002-D-0094, 67 FR 6545, February 12, 2002). The draft guidance was limited in application to special government employees (SGEs) participating in advisory committee meetings at which particular matters relating to particular products were discussed. In October 2007, after an internal assessment of FDA's advisory committee process, FDA published a revised draft guidance for public comment (72 FR 61657, October 31, 2007). The Agency reviewed the submitted comments on the January 2002 draft guidance, the October 2007 draft guidance, and the results of the internal assessment of FDA's advisory committee process and issued guidance that expanded public availability of relevant information to include regular Government employees and SGEs, brought additional transparency to FDA's waiver process, and increased the consistency and clarity of the process (73 FR 45459, August 5, 2008) (www.fda.gov/​downloads/​RegulatoryInformation/​Guidances/​ucm125647.pdf).

In the Federal Register of April 22, 2010 (75 FR 21000), FDA issued for public comment “Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers,” dated March 2010. The Agency explained that it tentatively concluded it is appropriate for additional information to be disclosed for individuals receiving a waiver of conflict of interest prior to participating in an FDA advisory committee meeting. Specifically, FDA proposed disclosure of the name of the company or institution associated with the financial interest. The Agency based its draft guidance on the expectation that: (1) This information would help the public understand the nature of the potential conflict and FDA's decision-making and that (2) individuals invited as advisory committee members would agree to the inclusion of this level of detail as a routine part of required disclosures. FDA specifically requested comments on whether disclosing the name of the company or institution associated with the financial interest would: (1) Increase the transparency of FDA's decisions regarding advisory committee member participation and (2) not significantly deter current and potential advisory committee members from service on those committees. The draft guidance also included a template for disclosing to the public the financial interests for which waivers are granted, a template for public disclosure of waivers that FDA grants, and FDA's process for making these documents available on its Web site.

We received several comments on the draft guidance. No commenter indicated that the proposed policies would deter participation and most noted that it would increase transparency.

FDA is issuing the draft guidance with minor revisions to improve clarity.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on the public availability of financial interest information and waivers relating to the disclosure of conflicts of interest for advisory committee members participating in FDA advisory committee meetings. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​AdvisoryCommittees/​default.htm.

Dated: February 28, 2012.

Leslie Kux,

Acting Assistant Commissioner for Policy.