Order Code RS22691
Updated July 12, 2007
FDA Advisory Committee Conflict of Interest
Reform Efforts in the 110th Congress
Erin D. Williams
Specialist in Bioethical Policy
Domestic Social Policy
Summary
Legislation to reauthorize the Food and Drug Administration’s prescription drug
and medical device user fee programs — the Food and Drug Administration
Revitalization Act (S. 1082), and the Food and Drug Administration Amendments Act
of 2007 (H.R. 2900) — contains proposals to change the process of recruiting advisory
committee members, as well as some circumstances under which and processes by
which conflict of interest exceptions may be granted. Each of these bills has been
passed by its respective chamber of Congress, leaving differences between them to be
addressed in conference. This report will be updated as necessary.
Background
The Food and Drug Administration (FDA), within the Department of Health and
Human Services (HHS), regulates the safety of foods, and the safety and effectiveness of
drugs, biologics (e.g., vaccines), and medical devices. In order to help inform its
activities, FDA solicits input from advisory committees, which make recommendations
on specific regulatory actions that the agency is contemplating.1 Typically, the FDA
Commissioner follows those recommendations, but may choose to disregard them.
To be most credible and useful, many say that committees need to minimize the
possibility of, or be free from conflicts of interest. However, others note that the most
expert people in the field are often those involved directly or indirectly in the activities
about which FDA is seeking advice, creating the potential for such conflicts. In 2006 and
2007, the media has reported that FDA advisory committees are biased in favor of drug
approval, and that many committee members have conflicts of interest.2
1 Linda Ann Sherman, “Looking Through a Window of the Food and Drug Administration:
FDA’s Advisory Committee System,” Preclinica, vol. 2 no. 2, p. 99 (March/April 2004) at
[http://www.preclinica.com/pdf/articles/sherman_2-2.pdf].
2 For example, see “Public Citizen Exposes Frequent Financial Conflicts of Interest at FDA
(continued...)

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Current Law
FDA’s process for establishing and administering its advisory committees is rooted
in several sets of laws and regulations, the requirements of all of which are binding on the
agency. The general processes for establishing, operating, overseeing, and terminating
governmental advisory bodies — including FDA advisory committees — are laid out in
the Federal Advisory Committee Act (5 U.S.C. Appendix; FACA).3 A requirement that
committee members file a report disclosing a broad range of potential conflicts of interest
is based upon the Ethics in Government Act of 1978 (5 U.S.C. Appendix; EGA). A
second section of law, Scientific Advisory Panels (21 U.S.C. 355(n); SAP), applies
specifically to members of FDA advisory committees on drugs and biologics, but not
medical devices or food. It requires that each member of a drug or biologic advisory
committee publicly disclose all conflicts of interest that he or she may have with the work
to be undertaken by the panel.
Restrictions on committee participation and voting eligibility, as well as the potential
for waivers and exemptions from the restrictions, are articulated in two locations. One,
the SAP, precludes a member from voting on any matter where the member or the
immediate family of such member could gain financially from the advice given to the
HHS Secretary. The SAP permits the Secretary to grant a waiver, upon public disclosure
of the conflict of interest, if the waiver is necessary to afford the panel essential expertise.
The Secretary may not grant a waiver for a member of a panel when the member’s own
scientific work is involved.
The second law, Acts Affecting Personal Financial Interest (18 U.S.C. 208; AAPFI),
applies broadly to government employees, including FDA advisory committee members.
It generally imposes criminal penalties on any person participating in an advisory
committee who has conflicts based on certain financial interests, such as current or future
employment, or on a directorship role in an organization. The scope of disqualifying
financial interests under AAPFI have been interpreted broadly in regulation to include
any potential for gain or loss to the employee, which would include interests such as stock
ownership, for example (5 C.F.R. 2640.103(b)).
According to 18 U.S.C. 208(b), waivers of the AAPFI requirements are available
from the government official responsible for appointing the committee member if the
official either: (1) makes a written determination that the interest is not so substantial as
to be deemed likely to affect the integrity of the government service; or (2) certifies in
writing that the need for the individual’s services outweighs the potential for a conflict
of interest. FDA regulations generally specify that the agency will make the fullest
possible disclosure of records to the public, consistent with the privacy rights of
individuals, the property rights of persons in trade secrets and confidential commercial
or financial information, and the need for the agency to promote frank internal policy
deliberations and to pursue its regulatory activities without disruption (21 C.F.R. 20.20).
2 (...continued)
Advisory Committee Meetings,” Public Citizen website (April 25, 2006), at
[http://www.citizen.org/pressroom/release.cfm?ID=2184].
3 For more information, see CRS Report RL30260, Federal Advisory Committees: A Primer, by
Stephanie Smith.

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FDA has articulated a policy of disclosing copies of AAFPI waiver determinations, except
where a foreseeable harm would be caused by disclosure.4
Section 208 also allows for exemptions from AAPFI, if the Director of the Office of
Government Ethics issues a regulation applicable to all similarly situated advisory
committee members that the financial interest is too remote or too inconsequential to
affect the integrity of the government services. In fact, the FDA Commissioner has issued
such an exemption for advisory committee members representing specific interests:
... because members representing particular interests, e.g., a representative of labor,
industry, consumers, or agriculture, are included on advisory committees specifically
for the purpose of representing these interests, any financial interest covered by 18
U.S.C. 208(a) in the class which the member represents is irrelevant to the services
which the Government expects from them and thus is hereby exempted under 18
U.S.C. 208(b) as too remote and inconsequential to affect the integrity of their
services (21 C.F.R. 14.80(2)).
In other words, an industry representative is allowed to have a financial interest in
that industry.
Conflicts of Interest Proposals in S. 1082 and H.R. 2900
The Senate passed S. 1082 on May 9, 2007, and the House passed H.R. 2900 on July
11, 2007. The bills’ conflict of interest provisions are similar, but not identical.
Differences between them are expected to be addressed in conference.
Both S. 1082 and H.R. 2900 would amend the Federal Food, Drug, and Cosmetic
Act (FFDCA) Chapter VII, Subchapter A, by inserting certain provisions regarding
conflicts of interest and advisory committee membership. No provisions regarding
conflicts of interest or advisory committees currently exist in that particular section of the
FFDCA. Several of the provisions are similar to some present in the SAP (which only
applies to drug and biologic advisory committees), and their removal from that section
would make their terms applicable to all advisory committees. A summary and
comparison of the bills’ provisions is presented below.
Definitions. Both bills define advisory committee as a FACA-covered entity that
provides the Secretary with advice and recommendations regarding activities of the FDA.
In contrast, current FDA regulations also
cover non-FACA, ad hoc committees. The
Key change from current law: new law’s
bills define financial interest as it is
scope limited to FACA committees.
defined under AAFPI (18 U.S.C. 208(a)).
Key differences between the bills: none.
Current FDA regulations governing
Qualifications for members of standing
policy and technical advisory committees
require that committee members are subject to the same conflict of interest laws referred
to in the bills.
4 “Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees
Participating in FDA Product Specific Advisory Committees,” (January 2002), at
[http://www.fda.gov/oc/guidance/advisorycommittee.html].

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Appointments to Advisory Committees. Both bills contain similar
recruitment provisions requiring the Secretary to develop and implement effective
outreach to potential members of
advisory committees at universities,
Key change from current law: new recruitment
colleges, other academic research
mechanisms for advisory committee members;
centers, professional and medical
financial conflict exemptions discouraged.
societies, and patient consumer
Key differences between the bills: H.R. 2900
groups. H.R. 2900 would require the
requires consultation with specific FDA offices to
Secretary to consult with several
develop a recruitment strategy; specifies that guest
specific offices at FDA during this
experts with financial interests are permitted.
process; S. 1082 would not. Both
bills specify that recruitment activities
may include advertising at conferences, use of certain electronic media, and
communications related to certain federal research grants. Current law requires the FDA
Commissioner to post recruitment notices in the Federal Register (21 C.F.R. 14.82 (a),
14.84 (c)).
Regarding advisory committee members’ evaluation, both bills would require the
Secretary to review the expertise and EGA financial disclosure of committee nominees
so as to reduce the likelihood that any would require financial interest rule exceptions
under 18 U.S.C. 208(b).
H.R. 2900 contains a section that would specifically permit the participation of a
guest expert with financial interest if the Secretary determined that the guest had
particular required expertise. The guest would not be permitted to participate in the
committees’ discussion or voting. S. 1082 contains no parallel provision. Current FDA
regulations are similar to H.R. 2900, in that they permit advisory committees to confer
with any person who may have information or views relevant to any matter pending
before the committee (21 C.F.R. 14.31 (a)). They also permit the FDA Commissioner to
appoint persons as special government employees to be consultants to an advisory
committee. Consultants may be appointed to provide expertise, generally concerning a
highly technical matter, not readily available from the members of the committee (21
C.F.R. 14.31 (e)).
Granting and Disclosure of Waivers. Both bills would require each member
of an advisory committee to disclose financial interests to the Secretary prior to a meeting
on a particular matter. The SAP currently requires that each member of a panel publicly
disclose all conflicts of interest that
member may have with the work to
Key change from current law: new waiver and
be undertaken by the panel.
related public disclosure requirements.
Key differences between the bills: H.R. 2900
The bills would prohibit an
limits waivers to one per meeting.
advisory committee member from
voting on any matter considered by
the committee if the member has a
financial interest that could be affected by advice the committee gives to the HHS
Secretary. This restriction would be modified by an exemption and a waiver. Under the
terms of the exemption (like the exemption already present in the AAFPI), the member
would be allowed to vote if the interest was exempted by the Director of the Office of
Government Ethics as too remote or inconsequential to affect the member’s service. The

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waiver could be grated by the HHS Secretary if necessary to afford the advisory
committee with essential expertise, but would not available if the committee members’
own scientific work was involved. The terms of the waiver (including its scientific work
limitation) are similar to current law under SAP.
In accordance with its general provisions discouraging the use of waivers, H.R. 2900
would limit the number of waivers issued under the new provision described above to one
per meeting. This limitation has been the subject of debate, particularly from groups
advocating on behalf of individuals with rare diseases, where there may be few available
scientific experts — even fewer who have no conflict of interest. S. 1082 contains no such
limitation. The bills’ new waiver would be available in addition to the two that are
currently permissible under AAFPI.
Both bills would require the Secretary to disclose certain information on the FDA
website in the event that he or she issued a waiver under AAFPI or the bill’s provisions.
The disclosed information would include the type, nature, and magnitude of the pertinent
financial interests and the reasons for the Secretary’s action. The disclosure would be
limited so as not to include information that is not subject to a Freedom of Information
Act (FOIA) request. The Secretary would be required to make the disclosure not less than
15 days prior to an advisory committee meeting, or, in the event that the financial interests
became known to the Secretary less than 30 days prior to the meeting, no later than the
date of the meeting. Required disclosures would be included in the public record and
transcript of each meeting. Current law has no parallel provisions, although, FDA
regulations generally favor disclosure, as specified above.
Annual Report. Both bills would require the Secretary to submit annual reports
to relevant congressional committees describing advisory committee vacancies, nominees,
and the number of nominees willing
to serve; the number of conflict-
Key change from current law: annual reports
related disclosures per meeting and
required regarding advisory committee
the percentage of members who did
membership, conflict of interest waivers.
not require such disclosures; the
Key differences between the bills: none.
number of times required disclosures
occurred less than 30 days in
advance of meetings; and how the Secretary plans to reduce the number of vacancies on
advisory committees and increase the number of nominations, including those of
academicians or practitioners. Current law contains no parallel provisions.
Periodic Review of Guidance.
Both bills would require the Secretary to
Key change from current law: guidance
review and update FDA conflict of interest
update required every 5 years.
guidance not less than once every five years.
Key differences between the bills: none.
Current law contains no parallel provisions.
Conforming Amendment. Both bills delete the provision in the SAP that
provides that “[e]ach member of a
panel shall publicly disclose all
conflicts of interest that member
Key change from current law: FFDCA amended
may have with the work to be
to conform to H.R. 2900 and S. 1082.
undertaken by the panel. No member
Key differences between the bills: none.

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of a panel may vote on any matter where the member or the immediate family of such
member could gain financially from the advice given to the Secretary. The Secretary may
grant a waiver of any conflict of interest requirement upon public disclosure of such
conflict of interest if such waiver is necessary to afford the panel essential expertise,
except that the Secretary may not grant a waiver for a member of a panel when the
member’s own scientific work is involved.” As specified above, language with a similar
effect would be inserted elsewhere, where it would apply to all advisory panels, rather that
just those concerning drugs and biologics.

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