[Federal Register Volume 67, Number 29 (Tuesday, February 12, 2002)]
[Notices]
[Pages 6545-6546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3279]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0049]


Draft Guidance on Disclosure of Conflicts of Interest for Special 
Government Employees Participating in FDA Product Specific Advisory 
Committees; 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availability of a draft guidance document entitled ``Disclosure of 
Conflicts of Interest for Special Government Employees Participating in 
FDA Product Specific Advisory Committees.'' This draft document is 
intended to provide guidance for industry, FDA staff (including special 
Government employees (SGEs), and other interested stakeholders 
concerning disclosure of financial interests for which FDA advisory 
committee SGEs have received conflict of interest waivers. This draft 
guidance describes a new policy of disclosing specific information 
concerning the financial interests that give rise to the waiver of a 
conflict of interest.

DATES: Submit written or electronic comments by March 14, 2002, to 
ensure adequate consideration in preparation of the final guidance 
document. Comments on this guidance may be submitted at any time.

ADDRESSES: Submit written comments or requests for copies of the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Linda Ann Sherman, Advisory Committee 
Oversight and Management Staff (HF-4), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-1220.

SUPPLEMENTARY INFORMATION:

I. Background

    Two separate statutes govern whether FDA advisory committee SGEs 
are prohibited from participating in a particular meeting because of a 
conflict of interest with the work the committee is to perform: (1) 
Section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 355(n)(4)), which is applicable to FDA SGEs working on 
advisory committees concerning a clinical investigation of a drug or 
approval for marketing of a drug or biologic; and (2) 18 U.S.C. 208, 
which is applicable to all Federal Government employees, including 
SGEs. Both statutes provide for waivers of conflicts of interest under 
certain conditions. Both statutes also provide for public disclosure of 
any conflict of interest for which a waiver has been granted. The 
regulation in 18 U.S.C. 208 provides for disclosure of waiver 
information upon request but permits agencies to redact any information 
that would be exempt under the Freedom of Information Act, 5 U.S.C. 
552. In addition, section 505(n)(4) of the act requires SGEs to 
publicly disclose all conflicts of interest.
    The Office of Government Ethics (OGE) has concluded that 18 U.S.C. 
208 grants agencies discretion in disclosing information under 18 
U.S.C. 208 where there is no foreseeable harm that will be caused by 
the disclosure. Similarly, the Office of Legal Counsel (OLC), 
Department of Justice, has concluded that FDA has discretion under 
section 505(n)(4) of the act to tailor the scope of the disclosure to 
achieve the statute's goal. FDA may weigh the competing public 
interests at stake. For example, the statute does not intend that the 
disclosure be so intrusive or onerous as to make many individuals 
unwilling to serve on advisory committees.
    In making a decision concerning how much information to disclose in 
any given case, FDA has always had to balance the following competing 
public interests: (1) Providing as much information to the public as 
possible about the qualifications and abilities of the SGEs involved in 
the advisory committee process so that individuals may weigh the 
advice, (2) protecting the reasonable privacy expectations of the SGEs 
in their personal financial affairs, and (3) protecting FDA's interest 
in being able to attract sufficient expertise to the committee to 
provide the most reliable advice.
    In the past, FDA has struck a balance between these interests by 
disclosing the names of individual SGEs who had received waivers and 
whether the waiver was granted under 18 U.S.C. 208 or section 505(n)(4) 
of the act, without disclosing any details about the actual financial 
interest at stake. In the interest of increasing transparency, FDA is 
now proposing to strike a different balance by disclosing more details. 
This disclosure, of course, will provide the public with more 
information concerning the financial interests of the SGEs 
participating, but it will also entail additional exposure of what may 
be private financial interests of the SGEs.

II. The Proposed New Procedures

    FDA is proposing that, for advisory committee meetings to consider 
particular matters relating to particular products, additional 
disclosure of certain details concerning conflicts of interest that 
have been waived is warranted. In the interest of uniformity, FDA is 
further proposing to provide for the same degree of disclosure for 
waivers granted under either 18 U.S.C. 208 or section 505(n)(4) of the 
act for all centers and will follow similar procedures for both. With 
regard to committees considering general matters, see the discussion in 
section III of this document.
    The reasons why FDA is proposing this change are twofold. First, 
FDA recently surveyed SGEs as to whether they were willing to provide 
greater public disclosure of financial interests giving rise to 
conflicts of interest for which waivers are received. FDA sent a 
detailed questionnaire to all SGEs asking for their opinion on whether

[[Page 6546]]

additional disclosure would be advisable. The survey and its tabulated 
results can be obtained by sending an electronic request to the Dockets 
Management Branch (address above). The results of that survey showed 
that, in general, SGEs were willing to tolerate greater disclosure of 
the financial interests than FDA had been providing.
    Second, OLC concluded that section 505(n)(4) of the act required 
meaningful public disclosure that will adequately enable a reasonable 
person to understand the nature of the conflict and the degree to which 
it could be expected to influence the recommendations the SGE will 
make.

III. General Matters Waivers Excluded

    Unlike advisory committee meetings to consider particular matters 
relating to particular products, committee meetings to consider more 
general matters do not have a unique impact on any personal or imputed 
financial interests. Such matters are likely to affect classes of 
similarly situated products and manufacturers to the same extent. 
Matters of such general applicability give no particular advantage to 
any individual manufacturer. Therefore, it is recognized that 
participation in committee meetings to consider general matters poses 
less risk of a conflict of interest. For that reason, FDA will continue 
to address committees considering general matters in a way that 
reflects these inherent differences. FDA will continue its global 
screening process for each general matter meeting, but in the public's 
interest of time and utility, it will read an abbreviated statement 
concerning conflicts of interest.

IV. Significance of Guidance

    The draft guidance entitled ``Guidance on Disclosure of Conflicts 
of Interest for Special Government Employees Participating in FDA 
Product Specific Advisory Committees'' is being issued as a level 1 
draft guidance consistent with FDA's good guidance practices regulation 
(21 CFR 10.115). This draft guidance represents the agency's current 
thinking on this topic. 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.

V. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments on the draft guidance to 
ensure adequate consideration in preparation of the final guidance 
document by March 14, 2002. However, interested persons may submit 
written or electronic comments at any time. Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at http://www.fda.gov/oc/guidance/advisorycommittee.html.

    Dated: February 5, 2002.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 02-3279 Filed 2-11-02; 8:45 am]
BILLING CODE 4160-01-S