Big Tobacco Claims FDA Stacked the Deck

     ALEXANDRIA, Va. (CN) – Lorillard and R.J. Reynolds Tobacco sued the U.S. Food and Drug Administration and the Department of Health and Human Services, claiming the federal agencies stacked the FDA’s Tobacco Products Scientific Advisory Committee with “a clique” who have “severe financial and appearance conflicts of interest and associated biases” on the tobacco industry.




     In their federal complaint, Lorillard and Reynolds claim three members of the FDA committee (TPSAC) and three members of its subcommittee also serve as “paid expert witnesses in litigation against tobacco-product manufacturers” and are employed as “consultants for … large pharmaceutical companies that manufacture nicotine-replacement-therapy products and other smoking-cessation products.”
     The tobacco companies also sued FDA Commissioner Margaret Hamburg, and Lawrence Deyton, director of the FDA’s Center for Tobacco Products, in a 73-page complaint that accuses them of violating the “applicable ethics rules” of the Federal Food, Drug, and Cosmetic Act.
     “Of the eight current voting members of the Committee, three (including the Chair) constitute a clique who have the same or similar views and are all on one side of the substantial controversy within public-health and tobacco-control communities as to whether enough is currently known to conclude that smokeless tobacco products can play a beneficial role in reducing the harm from tobacco,” the companies say.
     They claim that three members of a 12-member subcommittee of TPSAC also serve as expert witnesses in litigation against tobacco manufacturers.
     The cigarette makers claim the TPSAC’s allegedly unethical behavior will affect a report on the effects of menthol and the controversy over whether smokeless-tobacco products reduce the harm of tobacco.
     Lorillard and Reynolds want a declaration that the appointment of the six conflicted members of TPSAC and its subcommittee was arbitrary and capricious.
     And they want “the defendants … enjoined from transmitting, or otherwise making available, to the TPSAC or to its Constituents Subcommittee any of the Plaintiffs’ trade secret or confidential commercial documents or other trade secret or confidential commercial information provided heretofore by any of the Plaintiffs to any of the Defendants unless and until the TPSAC or the Constituents Subcommittee, as relevant, is lawfully composed; and that the Plaintiffs need not produce to any of the Defendants any trade secret or confidential commercial documents or other trade secret or confidential commercial information that otherwise would be provided to the TPSAC or to its Constituents Subcommittee unless and until the TPSAC and/or the Constituents Subcommittee, as relevant, is lawfully composed. “
     They are represented by Laura Klaus with Greenberg Traurig.

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