RICHARD J. LEON, United States District Judge.
This suit challenges the composition of the Tobacco Products Scientific Advisory Committee ("TPSAC" or "Committee"), a federal advisory committee established in 2010 by the U.S. Food and Drug Administration ("FDA") to provide advice and recommendations on scientific issues relating to tobacco products. The suit also challenges the process by which that committee drafted a 2011 report on the use of menthol in cigarettes ("Menthol Report").
Plaintiffs assert five causes of action alleging lack of compliance with ethics laws and the Federal Advisory Committee Act ("FACA"), 5 U.S.C. app. 2 §§ 1-16, all in violation of the Administrative Procedure Act ("APA"), 5 U.S.C. § 551 et seq. 3d Am. Compl. ¶¶ 129-84. With regard to the Committee's composition, plaintiffs allege that defendants' appointment of three voting committee members—Drs. Neal Benowitz, Jack Henningfield,
Next, with regard to the TPSAC's deliberative process, plaintiffs allege that: members of the Committee held a private meeting on March 17, 2011, in violation of FACA, because the meeting was not open to the public and timely notice of the meeting was not previously published, 3d Am. Compl. ¶¶ 150-57 (Count Four); and defendants, in violation of FACA, failed to disclose various documents that were created by the TPSAC and its subcommittee and related to the Menthol Report. 3d Am. Compl. ¶¶ 158-84 (Count Five). As a remedy for these alleged violations of ethics laws and FACA under the APA, plaintiffs seek, inter alia, an order enjoining the FDA to reconstitute the TPSAC's membership so that it complies with applicable ethics laws and FACA, and an injunction barring defendants from using the allegedly "tainted" Menthol Report. 3d Am. Compl. at 84-91; see also Pls.' Unredacted Reply Mem. ("Pls.' Reply") [Dkt. # 77] at 23-24.
Before the Court are the parties' cross-motions for summary judgment.
Until recently, the FDA lacked authority to regulate tobacco products. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) (holding that FDA lacked authority under the Federal Food, Drug, and Cosmetic Act ("FDCA") to regulate tobacco products as customarily marketed). In 2009, however, Congress passed the Family Smoking Prevention and Tobacco Control Act ("TCA" or "Act"), Pub. L. No. 111-31, 123 Stat. 1776 (2009), which authorized the FDA "to regulate tobacco products under the [FDCA] . . . by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products." Id. § 3(1) (Purpose). In part of that Act, Congress established the TPSAC, a twelve-member advisory committee, to "provide advice, information, and recommendations to the Secretary [of DHHS]" relating to the regulation of tobacco. 21 U.S.C. § 387q(c).
The TCA authorizes the Secretary of DHHS to refer certain matters to the TPSAC. For instance, the FDA "may refer a proposed regulation for the establishment, amendment, or revocation of a tobacco product standard to the [TPSAC] for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment." 21 U.S.C. § 387g(d)(5)(A). Or the agency may refer an application to produce and distribute a "new tobacco product" to the Committee for a report and recommendation. 21 U.S.C. § 387j(b)(2).
But the TCA also affirmatively requires the Secretary to refer certain matters to the TPSAC. As relevant here, Congress chose to set two specific priorities for the Committee to address upon its formation, mandating, first, that "[i]mmediately upon the establishment of the [TPSAC] . . . the Secretary shall refer to the Committee for report and recommendation . . . the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities." 21 U.S.C. § 387g(e)(1). Second, Congress also directed that "[t]he Secretary shall refer to the [TPSAC] for report and recommendation . . . the issue of the nature and impact of the use of dissolvable tobacco products [("DTPs")] on the public health, including such use among children." 21 U.S.C. § 387g(f)(1). The TCA further required that the TPSAC submit its report on menthol within one year of its establishment and its report on DTPs within two years thereof. 21 U.S.C. § 387g(e)(2), (f)(2). In providing such advice, the TPSAC is obligated to address
Advisory committees that advise executive branch officials and agencies, such as the TPSAC, are governed by FACA, 5 U.S.C. app. 2 §§ 1-16. See Final Rule, Advisory Committee; Tobacco Products Scientific Advisory Committee; Establishment, 74 Fed.Reg. 43,042, 43,042 (Aug. 26, 2009) (acknowledging TPSAC is "governed by . . . the Federal Advisory Committee Act, which sets forth standards for the formation and use of advisory committees"). Congress passed FACA in 1972 "to ensure that new advisory committees be established only when essential and that their number be minimized; that they be terminated when they have outlived their usefulness; that their creation, operation, and duration be subject to uniform standards and procedures; that Congress and the public remain apprised of their existence, activities, and cost; and that their work be exclusively advisory in nature." Public Citizen v. Dep't of Justice, 491 U.S. 440, 446, 109 S.Ct. 2558, 105 L.Ed.2d 377 (1989) (citing 5 U.S.C. app. 2 § 2(b)). While Congress recognized that advisory committees "are frequently a useful and beneficial means of furnishing expert advice, ideas, and diverse opinions to the Federal Government," 5 U.S.C. app. 2 § 2(a), "Congress also feared the proliferation of costly committees, which were often dominated by representatives of industry and other special interests seeking to advance their own agendas," Cummock v. Gore, 180 F.3d 282, 284 (D.C.Cir.1999). Accordingly, "FACA's principal purpose was to enhance the public accountability of advisory committees established by the Executive Branch and to reduce wasteful expenditures on them." Public Citizen, 491 U.S. at 459, 109 S.Ct. 2558.
To achieve these purposes, FACA mandates, among other things, restrictions on the membership of advisory committees. As relevant here, FACA requires that any subsequent legislation establishing (or authorizing the establishment of) an advisory committee "shall . . . require the membership of the advisory committee to be fairly balanced in terms of the points of view represented and the functions to be performed by the advisory committee." 5 U.S.C. app. 2 § 5(b)(2). And any such legislation "shall" also "contain appropriate provisions to assure that the advice and recommendations of the advisory committee will not be inappropriately influenced by the appointing authority or by any special interest, but will instead be the result of the advisory committee's independent judgment." 5 U.S.C. app. 2 § 5(b)(3).
The TCA is an example of such subsequent legislation establishing an advisory committee. That Act sets forth specific criteria for appointing the twelve members of the TPSAC, including the expertise required:
21 U.S.C. § 387q(b)(1)(A). Further, the TCA provides that the nine members described in clauses (i)-(iii) will serve as voting members of the TPSAC, whereas the three tobacco industry representative members described in clauses (iv)-(vi) may not vote and "shall serve as consultants" to the voting members. 21 U.S.C. § 387q(b)(1)(B).
Notably, the provision barring tobacco industry representative members from voting is not the only way in which the TCA addresses FACA's requirement that advisory committee legislation must "contain appropriate provisions to assure that the advice and recommendations of the advisory committee will not be inappropriately influenced . . . by any special interest, but will instead be the result of the advisory committee's independent judgment." 5 U.S.C. app. 2 § 5(b)(3). The Act also includes a specific "conflicts of interest" provision governing the membership of the TPSAC:
21 U.S.C. § 387q(b)(1)(C).
In addition to this TPSAC-specific conflicts provision, however, general conflict of interest laws and regulations apply to the voting members of the Committee, who are considered "special government employees" ("SGE"). See 21 C.F.R. § 14.80(b)(1)(ii) (voting members of technical advisory committees are "subject to the conflict of interest laws and regulations" as SGEs); 18 U.S.C. § 202(a) (defining SGE); see also AR 32 (TPSAC Charter). Specifically, the voting members must comply with the laws and regulations prohibiting financial and appearance conflicts of interest set forth in 18 U.S.C. § 208, 21 U.S.C. § 379d-1(c), and 5 C.F.R. §§ 2635.401-402, 2635.501-502; 2640.103. Absent certain exceptions, it is unlawful for an SGE to "participate[] personally and substantially. . . through decision, approval, disapproval, recommendation, the rendering of advice, investigation, or otherwise," in any "particular matter" in which he has a "financial interest." 18 U.S.C. § 208(a).
5 C.F.R. § 2635.402(a)-(b); see also 5 C.F.R. § 2640.103(a) (mirroring language of § 2635.402(a) and stating "[t]he restrictions of 18 U.S.C. 208 are described more fully in 5 CFR 2635.401 and 2635.402").
Finally, in addition to explicating financial conflicts of interest, the OGE regulations also address "appearance" conflicts of interest. See 5 C.F.R. § 2635.501-502. An appearance conflict exists "[w]here an employee knows that a particular matter involving specific parties is likely to have a direct and predictable effect on the financial interest of a member of his household. . . and where the employee determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question his impartiality in the matter." 5 C.F.R. 2635.502(a).
The FDA issued the Charter for the TPSAC on August 7, 2009, see AR 30-33,
In identifying the original TPSAC members and alternates, the selection committee focused on the expertise and experience those members would bring to the topics to be addressed by the TPSAC. See AR 90-93; AR 2 (DHHS memo regarding establishment of TPSAC); AR 30 (Charter describing TPSAC's duties). According to the FDA, the voting members were selected in an effort "to recruit the best scientific experts and to ensure that TPSAC has a balanced composition of expertise to handle the complex tobacco-related issues that will come before it." AR 6141-42.
The FDA announced the initial nine voting members of the TPSAC on March 1, 2010.
Before appointing the TPSAC members, the FDA conducted initial screenings to address potential conflicts of interest. See 74 Fed. Reg. 43,147, 43,148 (Aug. 26, 2009) (Notice, Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee) ("FDA will ask the potential candidates to provide detailed information concerning matters related to financial holdings, employment, and research grants and/or contracts.").
In accordance with 21 U.S.C. § 379d-1(c), the FDA also conducted conflict of interest screenings for TPSAC members
Immediately following the FDA's appointment of TPSAC's members in March 2010, and thereafter, various tobacco manufacturers, including plaintiffs, objected to the agency that certain members were conflicted and biased based on their ongoing work as expert witnesses in tobacco litigation, or their consulting work in connection with smoking cessation products. 3d Am. Compl. ¶¶ 35-50 (detailing objections submitted to FDA and FDA's responses). The agency rejected these objections. Id. In addition, the FDA's meeting-by-meeting approvals of the members repeatedly found no conflicts.
The facts regarding the Challenged Members' alleged conflicts of interest are relatively straightforward and uncontested. Plaintiffs contend that these individuals' employment as consultants to the pharmaceutical industry regarding nicotine replacement therapy ("NRT") products and other smoking-cessation products, as well as their service as paid expert witnesses in litigation against tobacco product manufacturers, created both financial conflicts of interest and appearance conflicts of interest. See 3d Am. Compl. ¶¶ 51, 76; id. ¶¶ 56-69 (detailing Challenged Members' alleged conflicts).
Since the 1980s, Dr. Benowitz has consulted for numerous pharmaceutical companies about the design of their NRT and other smoking-cessation drugs. AR 6163, 25488-91, 25499-500, 25508-09; see also AR 6130-31, 6377-78, 6411. He consulted for affiliates of Pfizer, Inc. ("Pfizer") & GlaxoSmithKline plc ("GSK") as to such products, even while serving on the
Dr. Benowitz has also served as a paid expert witness for lawyers suing tobacco-product manufacturers. AR 6164-65, 25469-79, 25485-500, 25503-09; see also AR 6130. In that role, he has testified about the effect of menthol cigarettes on the public health. See AR 6164, 25474-75, 25486-87, 25496; see also AR 6131. He testified as a paid expert witness while serving on the TPSAC, AR 4402-03, and, as of June 30, 2010, he was designated to testify in 585 pending tobacco cases, AR 6164.
Before and while serving on the TPSAC, Dr. Henningfield consulted for GSK and other drug companies as to NRT and other smoking-cessation drugs. AR 27065-66, 6377-78, 6411-12. He also had an ownership interest in a company that was developing a patented NRT product. AR 4293, 6134-35, 6169.
Dr. Henningfield has testified as an expert for GSK, AR 3693, and for lawyers suing tobacco-product manufacturers, AR 6169, 25639-70; see also AR 6134-35. In that role—before, during, and since serving on the TPSAC—he has testified about the effect of menthol cigarettes on the public health. See AR 6415 & nn.6-10, 6429-30, 26847-48, 26859. As of June 30, 2010, he was designated to testify in 350 pending tobacco cases. AR 6169.
Dr. Samet received grant support from GSK at least six times, including in 2010. AR 6170 & n.64; see also AR 6136 & nn.37-38, 6378, 6412. He also led the Institute for Global Tobacco Control, funded by GSK and Pfizer. Until 2009, he had received regular honoraria from Pfizer for his service on the Pfizer Global Tobacco Advisory Board. AR 6170, 25673-74. But he was not consulting for GSK or Pfizer when FDA appointed him to the TPSAC or while serving on it.
Dr. Samet has also testified for lawyers suing tobacco-product manufacturers. AR 6170, 25673-78; see also AR 6135-36. As of June 30, 2010, he was designated to testify in two pending tobacco cases. AR 6170.
Upon its formation, the TPSAC devoted its first meetings to the impact of menthol in cigarettes on the public health, as directed by the TCA. Defs.' Mem. at 9-15; AR 6453-7482 (Mar. 30-31, 2010, TPSAC meeting); AR 8749-10056 (July 15-16, 2010, TPSAC meeting). After holding numerous public meetings and considering an array of materials and submissions, the TPSAC discussed and adopted a complete version of the Menthol Report at its March 18, 2011, meeting. The TPSAC then held a follow-up meeting on July 21, 2011, at which it considered proposed revisions, and then voted to adopt the final Menthol Report and submitted it to the FDA. AR 19433-684 (Menthol Report). In its Conclusions and Recommendations (Chapter 8), the Report concluded that "[m]enthol cigarettes have an adverse impact on public health in the United States" and "[t]here are no public health benefits of menthol compared to non-menthol cigarettes." AR 19655. The Report further recommended that "[r]emoval of menthol cigarettes from the marketplace would benefit the public health in the United
Plaintiffs initiated this action on February 25, 2011. See Compl. [Dkt. # 1]. After plaintiffs amended their complaint for the first time, see First Am. Compl. [Dkt. # 12], defendants filed a Motion to Dismiss (regarding Counts One through Four) [Dkt. # 18] on April 29, 2011. After plaintiffs once again amended their complaint to add a fifth cause of action, see Second Am. Compl. [Dkt. # 33], defendants filed an additional Motion to Dismiss regarding Count Five [Dkt. # 37] on September 8, 2011. This Court heard oral argument on the two motions on February 14, 2012, and after receiving supplemental memoranda from the parties [Dkts. ## 42, 43], I denied defendants' motions to dismiss. See Mem. Order (July 31, 2012) ("2012 Order") [Dkt. # 44]. I concluded that: (1) plaintiffs had standing; (2) their conflicts of interest challenges (Counts One and Two) were justiciable; (3) their FACA "fair balance" and "special interest" challenges (Count 3) were justiciable; and (4) concerning Counts Four and Five, the Menthol Report Subcommittee and its writing groups were advisory committees under FACA. Id. at 4-7. Thereafter, plaintiffs again amended their complaint on April 25, 2013, see 3d Am. Compl., and the parties briefed cross motions for summary judgment, the last of which was filed on September 23, 2013. See supra note 6.
Summary judgment is appropriate when the record evidence demonstrates that "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." FED. R. CIV. P. 56(a); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The burden is on the moving party to demonstrate an "absence of a genuine issue of material fact" in dispute. Celotex, 477 U.S. at 323, 106 S.Ct. 2548. In a case involving judicial review of final agency action under the APA, however, "the Court's role is limited to reviewing the administrative record." Air Transp. Ass'n of Am. v. Nat'l Mediation Bd., 719 F.Supp.2d 26, 32 (D.D.C.2010) (citations omitted). "[T]he function of the district court is to determine whether or not as a matter of law the evidence in the administrative record permitted the agency to made the decision it did." Select Specialty Hosp.-Bloomington, Inc. v. Sebelius, 893 F.Supp.2d 1, 2 (D.D.C.2012) (citations and internal quotation marks omitted).
The APA "establishes a cause of action for those `suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action.'" Koretoff
Plaintiffs challenge final agency action under the APA: the FDA's appointment of the Challenged Members to the TPSAC and its March 1, 2010, announcement of the TPSAC roster, as well as the FDA's subsequent meeting-by-meeting screenings of those members for conflicts of interest as to menthol and DTPs. In assessing plaintiffs' conflict of interest claims, I will proceed in two steps.
In order to address whether judicial review is available for the FDA's conflicts determinations, it is first important to properly characterize what this case is about. In their motion to dismiss, defendants
Undaunted, defendants have repackaged their argument for unreviewability, emphasizing now in their summary judgment motion that plaintiffs' appearance conflict of interest claim (Count Two) is unreviewable for another reason—it is precluded by regulation. See Defs.' Mem. at 26. Defendants point to 5 C.F.R. pt. 2635 ("Standards of Ethical Conduct for Employees of the Executive Branch")—the only set of regulations that addresses appearance conflicts of interest—which includes a provision entitled "Disciplinary and corrective action," providing, in relevant part:
5 C.F.R. § 2635.106(c). Defendants argue that the express language of this regulation bars plaintiffs from challenging whether the FDA complied with Part 2635, either through a private right of action or under the APA. See Defs.' Mem. at 26. In support, they rely on a case from our Circuit Court which found that similar language in an Executive Order ("E.O.") precluded private parties from bringing an APA action to challenge whether the agency complied with the E.O. See Air Transp. Ass'n v. FAA, 169 F.3d 1, 8-9 (D.C.Cir.1999); accord Defenders of Wildlife v. Jackson, 791 F.Supp.2d 96, 120-21 (D.D.C.2011). I disagree.
Put simply, I am not persuaded either that the provision's text overcomes the "strong presumption" in favor of reviewability of agency action under the APA, see PDK Labs. Inc. v. DEA, 362 F.3d 786, 792 (D.C.Cir.2004), or that the cited Circuit precedent is controlling here. First, § 2635.106(c) is not itself a judicial review provision, unlike the provision of the E.O. at issue in Air Transportation Association, which is titled "Judicial Review." See E.O. 12893, 59 Fed.Reg. 4233, 4235 (Jan. 31, 1994); PDK Labs. Inc., 362 F.3d at 792-93. Second, unlike the language of the provision of the E.O. at issue in Air Transportation Association—which provides, "This order is intended only to improve the internal management of the executive branch and does not create any right or benefit, substantive or procedural, enforceable by a party against the United States, its agencies or instrumentalities, its officers or employees, or any other person," E.O. 12893 (emphasis added)—there is no such limiting language of intent in
On the merits, plaintiffs contend that the Challenged Members had financial and appearance conflicts of interest because they (1) consulted for manufacturers of NRT drugs and other smoking-cessation drugs that would benefit from a ban or restriction on menthol cigarettes and/or DTPs, and (2) testified in lawsuits against tobacco product manufacturers. See Pls.' Mem. & Opp'n at 1; 3d Am. Compl. ¶¶ 51-69, 76-77, 129-140. As a result of these alleged conflicts, plaintiffs seek judicial review of the FDA's "creati[on] and maint[enance of] an advisory committee tainted by conflicts of interest." Pls.' Opp'n to Defs.' Mot. to Dismiss at 26. As I noted in my ruling on defendant's motion to dismiss, "[a]ny review of these actions by the Court would, of course, be highly deferential." 2012 Order at 5. But such deference is not boundless. Having reviewed the record in its entirety, I conclude that applicable ethics laws do not permit the FDA to do what it did here and compose a committee including a number of members with financial and appearance conflicts of interest.
As an initial matter, it is important to note that plaintiffs do not allege any direct violations of the TCA's specific conflicts of interest provision applicable to members of the TPSAC. See 21 U.S.C. § 387q(b)(1)(C). That is because this provision only contemplates conflicts arising from one perspective: it bars voting members from receiving any remuneration from tobacco industry businesses. Id. But notwithstanding how narrowly Congress drafted this specific conflicts provision, other general conflicts laws apply to FDA's composition of the Committee, and failure to adequately consider potential conflicts arising from the opposite end of the spectrum—i.e. entities with interests adverse to tobacco companies—would amount to "fail[ure] to consider an important aspect of the problem," State Farm Mut. Auto. Ins. Co., 463 U.S. at 43, 103 S.Ct. 2856. And to the extent the FDA did consider these potential conflicts, I must review its determinations for any "clear error of judgment," such as if the agency "offered an explanation for its decision that runs counter to the evidence before the agency," State Farm Mut. Auto. Ins. Co., 463 U.S. at 43, 103 S.Ct. 2856.
In Count One of their complaint, plaintiffs allege that the three Challenged Members have financial interests that create conflicts in violation of 18 U.S.C. §§ 202(a) and 208, 21 U.S.C. § 379d-1, and 5 C.F.R. Parts 2635 and 2640. These laws prohibit government employees from working on "particular matters" in which they have a financial interest. In plaintiffs' view, therefore, the FDA's appointment of the Challenged Members to the TPSAC was arbitrary and capricious in violation of the APA, 5 U.S.C. § 706(2)(A). See 3d Am. Compl. ¶¶ 130, 132. Plaintiffs also contend that the meeting-by-meeting screening and approval of these members by the FDA as to menthol and DTPs violated these ethics laws, and thus the APA. Pls.' Reply at 17. For the following reasons, I agree.
As a preliminary matter, defendants argue that plaintiffs' challenge to the appointment of individual TPSAC members should fail as a matter of law because the FDA's act of appointing is not a "particular matter" within the purview of applicable
Defendants nonetheless proceed to argue that if it is irrelevant whether or not the appointment itself is a "particular matter," then this Court could only review the appointment under the APA if the challenged TPSAC member "had a foreseeable conflict as to every future particular matter TPSAC was to address." Defs.' Opp'n & Reply at 24. Not so. The legislation establishing the TPSAC specifically mandated not just that the Committee would address menthol and DTPs, but that it would do so within its first and second years of existence, respectively. See 21 U.S.C. § 387g(e), (f). Accordingly, if any prospective members already had a conflict as to either or both of those particular two issues—which defendants do not dispute are, in fact, "particular matters"— then the very act of appointment itself implicates those two particular matters because the TPSAC was certain to address them. Put differently, screening potential members for appointment to the TPSAC was functionally no different from screening them before particular meetings to address menthol and DTPs.
Turning to the merits, plaintiffs contend that the Challenged Members had financial conflicts of interest because they: (1) consulted for manufacturers of NRT drugs and other smoking-cessation drugs that would benefit from a ban or restriction on menthol cigarettes and/or DTPs; and (2) testified in lawsuits against tobacco product manufacturers, before, during, and after serving on the TPSAC. See Pls.' Mem. & Opp'n at 18-20. An SGE, such as a TPSAC member, "is prohibited . . . from participating personally and substantially in an official capacity in any particular matter in which, to his knowledge, he . . . has a financial interest, if the particular matter will have a direct and predictable effect on that interest." 5 C.F.R. § 2635.402; see also § 2640.103. Plaintiffs argue that the Challenged Members' participation in the TPSAC's consideration of menthol and DTPs had a "direct and predictable effect" on their financial interests in consulting and expert testimony work. Under the circumstances of this case, I agree.
As described above, Drs. Benowitz and Henningfield consulted for manufacturers of NRT drugs and other smoking-cessation drugs, and Dr. Samet had the prospect of future fees from them. See supra 15-17 (Factual Background). Defendants contend that the FDA "conducted extensive screenings" of each TPSAC member (and,
First, as regards menthol, the FDA solicited advice from the DHHS Designated Agency Ethics Official, who concluded that the TPSAC's advice on menthol would have no "direct and predictable effect" on the financial interests of drug companies that manufacture smoking-cessation drugs. AR 4121. Further, the memorandum concluded that even "an outright ban on menthol cigarettes[] cannot be determined to result in an increased demand for tobacco cessation products." Id. Accordingly, in the agency's view, TPSAC members who performed consulting work for such drug companies had no financial conflict of interest. Please!
This conclusion defies common sense. A ban or sales restriction on menthol cigarettes would have a "direct and predictable effect" on the Challenged Members' financial interests because it would likely increase the sales of such smoking-cessation drugs by some amount, which would in turn lead the manufacturers of such drugs to demand further consulting services from the challenged members. See Pls.' Mem. & Opp'n at 51. Indeed, the TPSAC's own Menthol Report suggests that removing menthol cigarettes from the market would lead a substantial number of menthol smokers to try to quit, which would increase demand for cessation services, including smoking-cessation drugs. See AR 19660-62; Pls.' Mem. & Opp'n at 51-52. Suffice it to say, the causal connection between any recommendation by the TPSAC on menthol and the effect on the Challenged Members' financial interests in consulting fees from manufacturers of smoking-cessation drugs is sufficiently "close," and that effect (of whatever magnitude)
Next, as regards DTPs, defendants similarly argue that the FDA adequately screened the Challenged Members with regard to financial interests in consulting work related to smoking cessation products. See Defs.' Mem. at 29. In this case, the FDA actually did find that one of the Challenged Members, Dr. Henningfield, had a conflict of interest due to his ownership interest in a company developing an NRT drug and recused him from the July 21 and 22, 2011, TPSAC meetings regarding DTPs. AR 4293, 5344. But the FDA also concluded that the other Challenged Members, Drs. Benowitz and Samet, did not have conflicts of interest for two reasons:
The FDA erred in concluding that current, ongoing financial relationships with smoking-cessation drug manufacturers did not constitute a conflict. Since manufacturers of such smoking-cessation drugs compete with manufacturers of DTPs, see Pls.' Mem. & Opp'n at 24-25, and since Dr. Benowitz stood to profit from the sale of NRT drugs, he faced a conflict with regard to providing advice in the TPSAC's report on DTPs. See Pls.' Mem. & Opp'n at 54. Indeed, the regulations' own illustrative examples support this conclusion. As a specific example of a "disqualifying financial interest," Part 2640 includes the following scenario:
5 C.F.R. § 2640.103(b) (emphasis added). It is plain in this example that if the SGE physician did currently have "any business relationship" with the company developing the drug, he would have a conflict. And that is very nearly the situation in the instant case: the TPSAC was charged with studying the public health impact of a drug (i.e. DTPs), and Dr. Benowitz had an ongoing business relationship (i.e. consulting work) with companies developing "alternative" or competing drugs (i.e. smoking-cessation drugs). Accordingly, I find that the FDA's conclusion with regard to Dr. Benowitz was a "clear error of judgment."
Next, turning to the Challenged Members' previous work as paid expert witnesses in litigation against tobacco manufacturers, the FDA again concluded that such activity did not constitute a financial conflict of interest. Despite plaintiffs' protests, the FDA concluded that Drs. Benowitz's and Samet's testimony did not pose a conflict regarding the TPSAC's work on DTPs, AR 6446, 4291, 4293; Defs.' Mem. at 30, and that Dr. Henningfield's
As outlined in the Factual Background above, the Challenged Members not only testified in the past, but at the time of their appointment were slated to testify in pending cases. In particular, Drs. Benowitz and Henningfield and were designated to testify in hundreds of pending tobacco cases and had testified about menthol in the past. See supra 15-16. Those two Challenged Members thus had ongoing relationships with lawyers or firms extending into the future, regarding multiple cases in which they could be expected to give the same or similar testimony, which related to menthol. See Pls.' Mem. & Opp'n at 48-49. Accordingly, Drs. Benowitz and Henningfield had a conflict because they had a financial incentive to ensure that the Menthol Report did not include recommendations or statements that would undermine that future testimony. See Pls.' Mem. & Opp'n at 50.
Of course, the ethics laws cannot be applied so broadly as to disqualify from membership in an advisory committee every scientist who has ever testified as an expert witness. But where, as here, the two Challenged Members repeatedly testified against tobacco manufacturers, to similar opinions (which concerned menthol), and were committed to do so in the future, there is a conflict of interest because they have a financial incentive in protecting their opinions. The TPSAC's conclusions about menthol would undoubtedly have a "direct and predictable effect" on their ability to continue earning fees as expert witnesses. Pls.' Mem. & Opp'n at 50. Accordingly, I find that the FDA acted arbitrarily and capriciously in concluding that the Drs. Benowitz's and Henningfield's commitments to testify in the future did not constitute financial conflicts of interest.
For similar reasons, I also conclude that all three Challenged Members' consulting and expert testimony activities created appearance conflicts of interest. Unlike the financial conflicts plaintiffs raised to the FDA, the agency failed to even address these appearance conflicts and respond to plaintiffs' objection letters, see Pls.' Mem. & Opp'n at 20 n.30, and therefore acted arbitrarily and capriciously by "entirely fail[ing] to consider an important aspect of the problem." State Farm Mut. Auto. Ins. Co., 463 U.S. at 43, 103 S.Ct. 2856.
An appearance conflict exists "[w]here an employee knows that a particular matter involving specific parties is likely to have a direct and predictable effect on the financial interest of a member of his household . . . and where the employee determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question his impartiality in the matter . . ." 5 C.F.R. 2635.502(a) (emphasis added).
Moreover, whereas the plain language of the general conflict of interest regulations precludes viewing past business relationships as technically "financial conflicts," see supra 29-30, past relationships can nevertheless constitute appearance conflicts because they bear directly on a member's impartiality. Indeed, it is telling that the specific tobacco conflicts provision contained in the TCA has a retrospective focus, expressly disqualifying members who received "any salary, grants, or other payment or support" from any tobacco company in the 18-month period prior to serving on the TPSAC. 21 U.S.C. § 387q(b)(1)(C). If Congress deemed that past remuneration from tobacco companies constituted a conflict of interest, it stands to reason that past remuneration from direct competitors of those companies, such as manufacturers of smoking-cessation drugs, would also constitute a conflict of interest.
In picking the TPSAC, Congress specifically recognized that in order for the Committee's work product to be credible and reliable, it had to be perceived by both the public and the interested industries as being free of bias—in either direction. In short, conflicts of interest—whether actual or perceived—undermine the public's confidence in the agency's decision-making process and render its final product suspect, at best. Here, the presence of conflicted members on the Committee irrevocably tainted its very composition and its work product. In turn, the Committee's findings and recommendations, including reports such as the Menthol Report, are, at a minimum, suspect, and, at worst, untrustworthy.
Thus, for the foregoing reasons, the Court GRANTS, in part, plaintiffs' Motion for Summary Judgment [Dkt. # 67] and DENIES defendants' Motion for Summary Judgment [Dkt. # 65]. Accordingly, I will enter an order that (1) enjoins the FDA to reconstitute TPSAC's membership so that it complies with the applicable ethics laws, and (2) bars defendants from using the Menthol Report.
5 C.F.R. § 2640.103(a)(1).
