Judge Bars FDA From Using TPSAC Menthol Report

gavelRequires appointment of new TPSAC members.

Federal District Court Judge Richard Leon has issued a decision requiring the Food and Drug Administration (FDA) to appoint new members to the Tobacco Product Scientific Advisory Committee (TPSAC) and prohibiting the agency from using the report prepared by the TPSAC on the impact of the use of menthol in cigarettes on the public health, the National Association of Tobacco Outlets (NATO) reported.

The federal court ruling is significant, The FDA will now need to choose new members for the TPSAC that are impartial and unbiased, which could lead to more balanced decisions by the TPSAC in the future because its membership should be devoid of individuals that are financially interested in the potential outcome of the committee’s reports and future regulations. What’s more, the FDA will not be able to rely on the menthol report compiled by the TPSAC because the conflicted members on the committee tainted the report itself. This tainted nature of the TPSAC report could have implications for any future regulations that the FDA proposes for menthol cigarettes.

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The Family Smoking Prevention and Tobacco Control Act, the federal law that authorized the FDA to regulate tobacco products, included a provision to establish an advisory committee to provide advice and recommendations to the FDA on scientific issues relating to tobacco products. The FDA established the TPSAC in 2010 and at that time was comprised of 12 members, including seven doctors, scientists, or health care professionals, one employee of a state or local government, one member from the general public, and three representatives from the tobacco industry. The three industry members held non-voting positions on the TPSAC and the other nine members had voting rights.

In February of 2011, Lorillard Tobacco Company and R.J. Reynolds Tobacco Co. filed a lawsuit against the FDA seeking a court order to require the FDA to reconstitute the TPSAC’s membership so that it complies with ethics laws and to issue an injunction against the FDA from using the TPSAC’s menthol report. Specifically, the industry plaintiffs alleged that the FDA’s appointment of three of the TPSAC voting members was “arbitrary, capricious, an abuse of discretion, and otherwise not in compliance with law” because these three members had financial conflicts of interest or the appearance of conflicts. Under federal law, it is unlawful for an advisory committee member to participate in making decisions or recommendations in any matter that the committee member has a “financial interest.”

In his ruling, Judge Leon agreed with the industry plaintiffs that these three TPSAC members had conflicts of interest because of their on-going work as expert witnesses against tobacco companies in tobacco litigation and due to their consulting fees paid by pharmaceutical companies in connection with smoking cessation products such, as nicotine replacement therapy products. The FDA claimed that the voting members of the TPSAC 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.”

However, Judge Leon disagreed and concluded in his ruling 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.” This conclusion was based, in part, on the judge’s finding that if a member of the TPSAC “stands to profit from the sale of products that help people quit smoking, then he faces a conflict in his duty to render impartial advice regarding the regulation of menthol cigarettes, which comprise a substantial share of the cigarette marketplace.”

As a part of his ruling, Judge Leon also found that these conflicts of interest also tainted the menthol reported compiled by the TPSAC.

In this report, the voting members of the TPSAC concluded that “[m]enthol cigarettes have an adverse impact on the public health in the United States” and “there are no public health benefits of menthol compared to non-menthol cigarettes.” The report went on to recommend that “[r]emoval of menthol cigarettes from the marketplace would benefit the public health in the United States.” However, the report also found that there is insufficient evidence to support a conclusion that menthol cigarettes are more harmful than non-menthol cigarettes.” While the FDA subsequently conducted its own scientific review of the TPSAC menthol report, the agency reached many of the same conclusions as the TPSAC report.

In granting the remedy sought by the industry plaintiffs to appoint new members to the TPSAC and forbid the FDA from relying on the menthol report, Judge Leon summed up his reasoning as follows:

“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. The only way the agency can correct its error of law in evaluating the credentials of future members of the TPSAC is for this Court to remand the case to the agency for the appointment of a newly-constituted, interest free, TPSAC panel of authorities consistent with the applicable ethics laws.”

The FDA can appeal this court ruling, but it is not known at this time if the agency will appeal the decision.