Court Opinion

ID: 4119504
Source: CourtListenerOpinion
Date Created: 2017-01-27 22:40:32.325982+00
Date Added: 2024-06-11T13:29:13.745544
License: Public Domain

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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         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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         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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