FDA Advisory Committee Conflict of Interest

FDA Advisory Committee Conflict of Interest

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Pr
epared for Members and Committees of Congress

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On September 27, 2007, a comprehensive law reauthorizing existing Food and Drug
Administration (FDA) programs and expanding the agency’s authority to ensure the safety of
prescription drugs, medical devices, and biologics was signed into law: the Food and Drug
Administration Amendments Act of 2007 (FDAAA; P.L. 110-85; H.R. 3580). FDAAA Title VII
focused on the topic of conflicts of interest. It was added following some negative publicity about
the FDA’s process for addressing conflicts of interest within its advisory committees. FDAAA
requires changes in the way that FDA recruits and vets advisory committee members, and in the
circumstances under which conflict of interest exceptions may be granted.
This report details FDA’s new policies for addressing conflicts of interest in its advisory
committees. It will be updated as necessary.

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Background ............................................................................................................................... 1
General Requirements for Federal Advisory Bodies................................................................. 1
New Requirements under FDAAA ........................................................................................... 1
Recruitment......................................................................................................................... 2
Financial Interest Defined................................................................................................... 2
Disclosure of Candidates’ Interests..................................................................................... 2
Member Requirements and Prohibitions............................................................................. 2
Exceptions to Prohibitions .................................................................................................. 3
Limitation on Exceptions.................................................................................................... 4
Public Disclosure of Exceptions ......................................................................................... 4
FDA Actions Subsequent to the Passage of FDAAA................................................................ 4

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Author Contact Information ............................................................................................................ 5

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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 reported that FDA advisory
committees were biased in favor of drug approval, and that many committee members had
conflicts of interest.2
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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). The scope of permissible actions for government employees—
including advisory committee members—in matters in which they have a financial interest is
spelled out in Acts Affecting Personal Financial Interest (18 U.S.C. 208; AAPFI).
Ž ȱŽšž’›Ž–Ž—?œȱž—?Ž›ȱȱ
Congress enacted a major FDA law, reauthorizing expiring FDA user fee authorities and
enhancing the agency’s ability to ensure drug, device and biological product safety: the Food and
Drug Administration Amendments Act of 2007 (FDAAA; P.L. 110-85). FDAAA Title VII,
entitled Conflicts of Interest, changed the law governing FDA’s treatment of conflicts of interest
in its advisory committees. (21 U.S.C. 371 et seq.)4 It contains numerous requirements to
minimize conflicts of interest among FDA advisory committee members, and applies to all FACA
committees that advise the HHS Secretary on matters for the FDA.5 The following summarizes
FDA’s new advisory board policies in the wake of FDAAA.

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 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.
4 Federal Food, Drug and Cosmetic Act, §712.
5 FDAAA supplanted the conflict of interest provisions in the law governing FDA scientific advisory panels related to
(continued...)
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The FDAAA requires advisory committee member recruitment mechanisms to focus on reaching
experts from academia, professional and medical societies, and patient and consumer groups. The
HHS Secretary is required to develop outreach strategies to recruit from these sectors, and to seek
input and advice from professional and medical societies with respect to recruitment. Recruitment
activities may include advertising at conferences, electronic communications, and outreach to
entities receiving federal grant funding.
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In its definition of financial interest, the FDAAA refers to the AAPFI. AAFPI §208(a) defines the
term to include activities such as a person’s or their family members’ current or future
employment, trusteeship, or directorship. On its face, it does not apply to activities such as stock
ownership, former employment, or receipt of a grant or contract. However, the scope of
disqualifying financial interests under AAPFI have been interpreted broadly in regulation.
Regulations 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)).
’œŒ•˜œž›Žȱ˜?ȱŠ—?’?Š?ŽœȂȱ —?Ž›Žœ?œȱ
The EGA requires potential committee members to file a report specifying their potential
conflicts (5 CFR § 2634.903(b)(3)). The FDAAA requires the Secretary to review the reports
when considering a term appointment to an advisory committee. The review is to be conducted so
as to reduce the likelihood that general rules will have to be excepted (via written determination,
written certification, or waiver—see “Exceptions to Prohibitions” below).
The FDAAA also requires that, prior to an advisory committee meeting on a particular matter,
each committee member disclose to the Secretary financial interests in accordance with AAPFI
§208(b). Section 208(b) articulates various exceptions to the general prohibition against acting
with a financial interest defined in 208(a).
Ž–‹Ž›ȱŽšž’›Ž–Ž—?œȱŠ—?ȱ›˜‘’‹’?’˜—œȱ
Restrictions on committee participation and voting eligibility, as well as the potential for waivers
and exemptions from the restrictions, are defined in two locations. One, the FDAAA, precludes a
member from participating on a committee considering a particular matter in which the member
or their immediate family has a financial interest that could be affected by the advice given to the
Secretary.
The second law, AAFPI, 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.

(...continued)
drugs and biologics. (21 U.S.C. 355(n)).
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There are two sources of exceptions to the FDA advisory committee membership financial
interest prohibitions. One is AAFPI 208(b). As noted above, this section lists several exceptions
to the financial interest restriction spelled out in 208(a). The FDAAA contains the second set of
exceptions. It specifies two exceptions to the general prohibition. In addition, because the
FDAAA uses the AAFPI 208(a) definition of financial interest, it incorporates the 208(b)
exceptions to the definition. The following are the FDAAA and AAFPI exceptions:
• Written determination that an interest is not substantial. The AAFPI 208(b)(1)
allows the government official responsible for a committee members’
appointment to make, in advance of the meeting, a written determination that an
interest is not so substantial as to be deemed likely to affect the integrity of the
member’s service. To facilitate this, a member is required to advise the
government official responsible for his or her appointment of the nature of the
particular matter and make full disclosure of the financial interest.
• Written certification that the need for participation outweighs potential conflict.
The AAFPI 208(b)(3) provides that the official responsible for a committee
member’s appointment, after review of the EGA-required financial disclosure
report, certify in writing that the need for the individual’s services outweighs the
potential for a conflict of interest.
• Waiver for essential expertise. The FDAAA enables the Secretary to grant a
waiver to permit a member to participate despite a financial interst if that
person’s expertise is essential to the committee. The waiver may allow the person
to participate as a voting or non-voting member.
• Interest exempted as too remote. One additional exception is contained within the
FDAAA’s general prohibition on waivers and participation. It permits
participation by a person with an interest in a particular matter if the interest has
been exempted in regulations issued by the Director of the Office of Government
as too remote or inconsequential to affect the integrity of the member’s services.
This exemption is also articulated in AAFPI 208(b)(2).
Utilizing authority under this final exception (AAFPI 208(2)(b)(2)), the FDA Commissioner has
issued a blanket regulation making exemptions for a category of interests as too remote:
... 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 on an advisory committee is allowed to have a financial
interest in that industry. This exemption was made prior to the enactment of the FDAAA, but
should not be affected by the law.
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The FDAAA restricts the percentage of committees’ membership that may consist of people
having received one of three types of exceptions to the financial conflict prohibitions: (1)
FDAAA waivers for essential expertise, (2) AAFPI written determinations, and (3) AAFPI written
certifications. For FY2007, the Secretary was required to determine the number and proportion of
advisory members who received exceptions. For FY2008 through FY2012, the Secretary must
reduce the proportion of excepted members by an additional 5% per year from the FY2007
number. This limitation does not apply to financial interest exemptions made under 18 USC
208(b)(2), or the parallel provisions in the FDAAA.
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The FDAAA requires public disclosures for conflict-of-interest determinations, certifications, and
waivers (but not 208(b)(2) exemptions), except for those exempted from disclosure under the
Freedom of Information Act of 1974 (5 USC 522). It requires the Secretary to submit annual
reports regarding advisory committee membership, and conflict-of-interest waivers. It also
requires the Secretary to review and update FDA conflict-of-interest guidance not less than once
every five years.
FDA regulations that precede the FDAAA 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). FDA has articulated a policy of
disclosing copies of AAFPI waiver determinations, except where a foreseeable harm would be
caused by disclosure.6
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Following the passage of the FDAAA, the FDA took several actions to implement, and in some
cases, exceed the terms of the FDAAA. According to the agency, its policies on advisory
committees continue to be informed by new studies on conflicts of interest. FDA asked a
consultant, Eastern Research Group, to study 16 recent advisory committees. The report
highlighted the difficulty of assembling highly qualified experts who were free of conflicts, and
found that those who had received waivers appeared to be significantly more qualified than those
who had not received waivers.7

6 “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.
7 Nyssa Ackerley, John Eyraud, and Marisa Mazzotta, “Measuring Conflict of Interest in FDA Advisory Committees,”
Eastern Research Group, (October 26, 2007), at http://www.fda.gov/oc/advisory/ERGFDAAAreport.pdf.
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Erin D. Williams

Specialist in Public Health and Bioethics
ewilliams@crs.loc.gov, 7-4897

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