[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Notices]
[Pages 21000-21001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0094] (formerly Docket No. 02D-0049)


Draft Guidance for the Public, Food and Drug Administration 
Advisory Committee Members, and Food and Drug Administration Staff: 
Public Availability of Advisory Committee Members' Financial Interest 
Information and Waivers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for the public, FDA advisory committee 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.'' This 
draft guidance is intended to help the public, FDA advisory committee 
members, and FDA staff to understand and implement FDA procedures 
regarding public availability of information regarding certain 
financial interests and waivers granted by FDA to permit individuals to 
participate in an advisory committee meeting. The draft guidance would 
provide even greater transparency to FDA's advisory committee process 
than current guidance. The draft guidance announced in this notice, 
when finalized, would replace guidance of the same title dated August 
2008.

DATES: Although you may comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by June 21, 2010.

ADDRESSES: Submit written requests for single copies of the guidance to 
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 requests. Submit phone requests to 800-835-4709 or 301-827-1800. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Office of Special 
Medical Programs, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, rm. 5103, Silver Spring, MD 20993, 301-796-8220.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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's advisory committees provide 
independent and expert advice on scientific, technical, and policy 
matters related to the development and evaluation of products regulated 
by FDA. FDA implements a rigorous process for soliciting and vetting 
candidates for advisory committee meetings to minimize any potential 
for financial conflicts of interest. The agency is authorized by 
statute to grant waivers to allow individuals with potentially 
conflicting financial interests to participate in meetings where we 
conclude, after close scrutiny, that certain criteria are met. (See 18 
U.S.C. 208(b)(1) and (b)(3), section 712(c)(2)(B) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 379d-1) (added by the Food 
and Drug Administration Amendments Act of 2007, Public Law No. 110-85), 
and section 701 (21 U.S.C. 371) (effective October 1, 2007)).
    In January 2002, FDA issued the ``Draft Guidance on Disclosure of 
Conflicts of Interest for Special

[[Page 21001]]

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). 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 August 2008, after an internal assessment of FDA's advisory 
committee process and based on the comments submitted to the docket for 
the January 2002 draft guidance and a revised draft guidance published 
for public comment in October 2007, the agency issued guidance that 
expanded public availability of relevant information, brought 
additional transparency to FDA's waiver process, and increased the 
consistency and clarity of the process (www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125647.pdf).
    FDA is now making available for public comment revisions to the 
August 2008 guidance that provide even greater transparency. The agency 
has tentatively concluded that it is appropriate to request that 
individuals receiving a waiver of conflict of interest to participate 
in an FDA advisory committee meeting disclose the name of the company 
or institution when identifying the ``nature'' of the disqualifying 
financial interest.
    In determining how much information to publicly disclose, FDA needs 
to provide enough detail so the public can understand the nature of the 
potential conflict and FDA's decisionmaking regarding participation, 
while not disclosing so much detail that the agency would be unable to 
attract essential expertise to its advisory committees. Under the 
August 2008 guidance, the nature of the financial interest was 
identified only as sponsor, competitor, or other affected firm. This 
approach was informed, in part, by a survey in 2001 of active advisory 
committee members that asked whether members would decline to 
participate based on varying levels of disclosure.
    FDA is now proposing to disclose more detail than it did under its 
August 2008 guidance. Specifically, the agency proposes to disclose the 
name of the company or institution associated with the financial 
interest. New information indicates that this additional detail would 
not be a deterrent to current and potential advisory committee members. 
For example, the agency notes that academic institutions, peer-reviewed 
journals, and scientific symposia, among other entities/venues, have in 
recent years developed more rigorous policies for disclosure of 
potential conflicts of interest with the work that is being presented 
or discussed. (See ``Conflict of Interest in Medical Research, 
Education, and Practice, Committee on Conflict of Interest in Medical 
Research, Education, and Practice, Board on Health Sciences Policy,'' 
Institute of Medicine of the National Academies (see p. 62 at http://books.nap.edu/openbook.php?record_id=12598). While policies differ 
among organizations, many provide for disclosure of the name of the 
company or entity constituting the potential conflict of interest. (See 
``Uniform Format for Disclosure of Competing Interests in ICMJE 
Journals'' that describes a disclosure policy and format that includes 
identification of the entity that is the source of the financial 
interest; adopted by all International Committee of Medical Journal 
Editors (ICMJE) journals (accessed at http://content.nejm.org/cgi/content/full/361/19/1896)). In addition, FDA informally polled several 
active advisory committee members. While not a representative sample, 
the survey indicated that disclosing the names of companies would not 
adversely affect FDA's ability to attract and retain expert advisors. 
Accordingly, we have tentatively concluded that the public now expects 
this level of detail to help them understand the nature of a potential 
conflict and that individuals would accept this level of detail as a 
routine part of required disclosures.
    To help us in issuing a final guidance, FDA is requesting 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 includes a template for disclosing to the 
public the financial interests for which waivers are granted and a 
template for disclosing to the public all waivers that FDA grants. The 
draft guidance further describes FDA's process for making these 
documents available on its Web site in advance of each advisory 
committee meeting.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on public 
availability of information regarding advisory committee members' 
financial interests and waivers granted by FDA to permit participation 
in 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) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

II. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm 
or http://www.regulations.gov.

    Dated: April 19, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-9313 Filed 4-21-10; 8:45 am]
BILLING CODE 4160-01-S