[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Draft Guidance for the Public, Food and Drug Administration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availability of a draft guidance for the public, FDA advisory committee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draft guidance is intended to help the public, FDA advisory committee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 The draft guidance would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 The draft guidance announced in this notice,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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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Submit written comments on the draft guidance to the Division of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]
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