Filed: Oct. 05, 2001
Latest Update: Mar. 03, 2020
Summary: 1, We have not been asked to, and do not, opine on whether a drug advisory panel member must, publicly disclose a conflict of interest that the member may have with a matter to be undertaken by the, panel if the member, instead of seeking a waiver, chooses not to take part at all in the matter.
Disclosure of Conflicts of Interest of Members of
FDA Advisory Panels
Special government employees who serve as members of a Food and Drug Administration advisory
panel and who seek waivers of conflicts of interest must publicly disclose any conflicts of interest
they may have that relates to the work to be undertaken by the panel. The FDA may not waive a
panel member’s conflict until the panel member makes the public disclosure.
The FDA has considerable discretion to determine how detailed the panel member’s disclosure must
be, so long as such disclosure is adequate to inform the public of the nature and magnitude of the
conflict.
October 5, 2001
MEMORANDUM OPINION FOR THE CHIEF COUNSEL
FOOD AND DRUG ADMINISTRATION
You have asked for our opinion whether the Food and Drug Administration
(“FDA”), in granting conflict of interest waivers to special government employees
serving as members of FDA advisory panels on new drugs and biological products
(“drug advisory panels”), must require panel members to disclose publicly their
conflicts of interest. You have further informed us that the FDA’s current practice
with respect to waivers of such conflicts of interest is to disclose the fact that a
particular panel member has been granted a waiver of a conflict, but not to identify
the nature of the conflict or provide any further details. See Memorandum for
Daniel Troy, Chief Counsel, from Matthew Eckel, Associate Chief Counsel, Food
and Drug Administration, Re: Request for Advice from Office of Legal Counsel,
Department of Justice Concerning Disclosure of Advisory Committee Member
Conflicts of Interest (Sept. 17, 2001) (“FDA Memorandum”).
As discussed below, we conclude that special government employees who
serve as members of an FDA drug advisory panel and who seek waivers of
conflicts of interest must publicly disclose any conflicts of interest they may have
that relate to the work to be undertaken by the panel. 1 The FDA may not waive a
panel member’s conflict until the panel member makes the public disclosure. The
FDA has considerable discretion to determine how detailed the panel member’s
disclosure must be, so long as such disclosure is adequate to inform the public of
the nature and magnitude of the conflict.
1
We have not been asked to, and do not, opine on whether a drug advisory panel member must
publicly disclose a conflict of interest that the member may have with a matter to be undertaken by the
panel if the member, instead of seeking a waiver, chooses not to take part at all in the matter.
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Disclosure of Conflicts of Interest of Members of FDA Advisory Panels
I. Panel Members Must Publicly Disclose Their Conflicts of Interest
Section 355(n) of title 21 provides that “[f]or the purpose of providing expert
scientific advice and recommendations to the Secretary [of Health and Human
Services] regarding a clinical investigation of a drug or the approval for marketing
of a drug under section 355 of this title [(new drugs)] or section 262 of Title 42
[(biological products)], the Secretary shall establish panels of experts or use panels
of experts established before November 21, 1997, or both.” 21 U.S.C. § 355(n)(1)
(Supp. III 1997). Within 90 days after a drug advisory panel makes its recommen-
dations, the FDA must review the panel’s conclusions and recommendations and
notify the affected persons of any final decision. Id. § 355(n)(8).
Section 355(n)(4) sets out specific conflict of interest requirements for mem-
bers of drug advisory panels:
Each member of a panel shall publicly disclose all conflicts of inter-
est that member may have with the work to be undertaken by the
panel. No member of a panel may vote on any matter where the
member or the immediate family of such member could gain finan-
cially 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 sci-
entific work is involved.
Id. § 355(n)(4). Thus, the plain terms of section 355(n)(4) require that each
member of a drug advisory panel “publicly disclose all conflicts of interest . . .
with the work to be undertaken by the panel” and that the Secretary not waive any
such conflicts before public disclosure has occurred.
You have asked, however, whether various other statutes relating to conflict of
interest requirements for government employees should be read to negate or limit
the obligation that section 355(n)(4) imposes.
Pursuant to section 107(a)(1) of the Ethics in Government Act of 1978, as
amended, 5 U.S.C. app. §§ 101-111 (2000) (“EGA”), the FDA requires each
member of a drug advisory panel to file a confidential financial disclosure report.
See FDA Memorandum at 2. Section 107(a)(2) in turn provides that “[a]ny
information required to be provided by an individual under this subsection shall be
confidential and shall not be disclosed to the public.” 5 U.S.C. app. § 107(a)(2).
You further note that the Office of Government Ethics (“OGE”) has advised that
even with the consent of the individual filer, the agency is barred by section
107(a)(2) from publicly releasing information on the filer’s financial disclosure
report. See Privacy of SF 450 Financial Disclosure Information and Waivers
Issued to Advisory Committee Members under 18 U.S.C. § 208(b)(3), Informal
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Opinions of the Office of Legal Counsel in Volume 25
Advisory Op. 93x34, at 4 (Nov. 16, 1993), available at http://www.oge.gov/OGE-
Advisories/Legal-Advisories/Legal-Advisories/ (last visited May 24, 2012) (“OGE
Letter”). 2 You therefore raise the question how section 107(a)(2) is to be read
together with the plain language of section 355(n)(4).
We believe that section 107(a)(2) has no impact on how section 355(n)(4)
should be read. Section 355(n)(4) imposes a disclosure obligation not on the FDA,
but only on individuals who choose to be members of a drug advisory panel. The
OGE Letter provides only that the filer’s consent does not enable the agency to
release the filer’s financial disclosure report. The OGE Letter does not remotely
suggest that section 107(a)(2) bars the filer from publicly releasing his own
financial disclosure report. (Indeed, any such bar, apart from having no evident
purpose, would likely violate the First Amendment.) We therefore see no conflict
between section 107(a)(2) and section 355(n)(4).
Because section 107(a)(2) and section 355(n)(4) do not conflict, FDA regula-
tions that would implement section 355(n)(4)’s command that drug advisory panel
members publicly disclose their conflicts of interest would likewise not violate
section 107(a)(2). We note further that section 355(n)(4) could reasonably be read
to contemplate that panel members use FDA resources to make public disclosure
of their conflicts; in the event that the FDA so reads section 355(n)(4), we believe
that such an FDA role in facilitating panel members’ disclosure would not violate
section 107(a)(2).
You present an argument that the federal criminal conflict of interest statute, 18
U.S.C. § 208 (1994), permits an agency to grant a special government employee
an exemption from its prohibitions in certain circumstances, see id. § 208(b)(3);
that an agency, in providing the public a copy of any determination granting such
an exemption, may withhold from disclosure any information that would be
exempt from disclosure under the Freedom of Information Act (“FOIA”), 5 U.S.C.
§ 552 (2000), see 18 U.S.C. § 208(d)(1); that FOIA exempts from its mandatory
disclosure requirements any information specifically exempted from disclosure by
another statute, see 5 U.S.C. § 552(b)(3); and that the FDA, in granting a drug
2
The OGE Letter further advises that “[t]he agency must observe the [section 107(a)(2)] constraint
against release of the information on the form, even if the individual filer has discussed the same or
similar information in another forum or the nature of certain of the filer’s holdings may be known in his
or her industry or community.” Id. at 5. Read broadly, this advice might mean that an agency may
never disclose information if that information happens to be contained in a financial disclosure report,
even if the agency relied on an independent source to obtain the information. Under such a broad
reading, an agency would be barred, for example, from disclosing a filer’s business address if that
business address were contained in the filer’s financial disclosure report, even if the agency relied on
other records to determine the filer’s business address (or even if that business address were in the
phone book). Alternatively, the OGE advice may mean only that under section 107(a)(2) an agency
may not release a financial disclosure report or information obtained from that report but may still
release information from independent sources, even if that information is also contained in the financial
disclosure report. We have not been asked to, and need not, decide which is the better reading of
section 107(a)(2).
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Disclosure of Conflicts of Interest of Members of FDA Advisory Panels
advisory panel member an exemption under 18 U.S.C. § 208(b)(3) from the
application of the criminal conflict of interest prohibitions, is therefore authorized
not to disclose information exempted from disclosure under section 107(a)(2) of
the EGA. See FDA Memorandum at 3-7. We see no need to address the merits of
this argument, for we do not believe that, even if correct, it is in any respect in
tension with the plain language of section 355(n)(4). Just as we conclude above
that a bar on the FDA’s disclosure of a drug advisory panel member’s financial
disclosure report filed pursuant to the EGA is entirely consistent with section
355(n)(4)’s requirement that the member publicly disclose all conflicts of interest
before obtaining a waiver, so we conclude here that the FDA’s permissive
authority not to disclose the member’s report would be consistent with that same
requirement.
We therefore conclude that none of the other statutory provisions you raise
negates or limits the application of section 355(n)(4).
II. The FDA Has Discretion to Determine the Scope of the
Required Disclosure
You have also requested our opinion concerning the scope of any disclosure
required under section 355(n)(4)—in particular, the amount of background
financial information a panel member must disclose with respect to a particular
conflict of interest. See FDA Memorandum at 9, 12. The language of the statute
provides little guidance in interpreting the phrase “publicly disclose all conflicts of
interest,” and thus appears to leave the agency some discretion in determining how
best to implement the statutory mandate. Indeed, just as the statute explicitly gives
the Secretary discretion to decide when the need for an individual’s expertise
justifies waiving a conflict of interest, we believe that it implicitly permits the
Secretary, in developing administrative guidelines for disclosure, to consider the
competing public interests at stake.
In enacting section 355(n)(4), Congress clearly sought to promote the strong
public interest in knowing whether individuals involved in the approval of new
drugs and biological products are potentially biased by conflicting financial
interests. Accordingly, any regulations implementing section 355(n)(4) must
require an advisory panel member, before receiving a waiver of any conflict of
interest, to provide meaningful public disclosure that would 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 member would make.
Mere identification of the conflicting interest may be insufficient to meet this
standard; it will often be necessary also to provide information concerning the
magnitude of a particular financial interest (e.g., whether it consists of a few
shares of stock or a controlling interest in a company). On the other hand,
Congress surely did not intend that the disclosure requirement should be so
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Opinions of the Office of Legal Counsel in Volume 25
intrusive or onerous as to make many individuals unwilling to serve on advisory
panels, as such a result would deprive the FDA of the “essential expertise”
Congress intended the advisory panels to provide. The FDA may therefore tailor
the scope of the requirement so that it does not impose a greater burden than
necessary to achieve the statute’s goal.
M. EDWARD WHELAN III
Principal Deputy Assistant Attorney General
Office of Legal Counsel
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