Lawsuit Alleges Bias and Conflicts of Interest in FDA’s Tobacco Products Scientific Advisory Committee

By David B. Clissold –

In a federal lawsuit filed on Friday, February 25, 2011 in the District of Columbia, Lorillard, Inc., Lorillard Tobacco Company, and R.J. Reynolds Tobacco Company sued the FDA, DHHS, Kathleen Sebelius, Margaret Hamburg, and Lawrence Deyton for declaratory and injunctive relief to bring the membership of the Tobacco Products Scientific Advisory Committee (“TPSAC”) and the membership of the Constituents Subcommittee of the TPSAC into compliance with the law, and to prevent the defendants from taking any action based on any report or advice provided by the TPSAC or the Constituents Subcommittee.  The complaint alleges that several members of these committees have financial interests and biases that potentially compromise their impartiality.  The plaintiffs state that these conflicts and biases stem from the members’ service as expert witnesses in litigation against tobacco-product manufacturers and their current or recent employment as consultants to the pharmaceutical industry regarding nicotine replacement therapy products and other smoking-cessation products. 

The TPSAC is currently drafting a report on menthol in cigarettes (due March 23, 2011) and will then consider dissolvable products, and the Constituents Subcommittee is currently preparing a report on constituents in cigarette smoke.  The complaint alleges that some of the TPSAC members have incentives to lead the TPSAC to develop a negative report on menthol in cigarettes, since “such a report would be of financial benefit to them in their roles as consultants to pharmaceutical companies that manufacture nicotine replacement therapy products” and “would enhance their value as paid expert witnesses in lawsuits against manufacturers of menthol cigarettes.”  The plaintiffs also touch upon the controversy within the public-health and tobacco-control communities over a possible role for smokeless tobacco products in reducing the harm from tobacco in the United States, thus potentially qualifying such products as a “modified risk tobacco product.” The complaint alleges that the non-voting members of the TPSAC have been excluded from the preparation of the TPSAC report on menthol in cigarettes, and that the defendants “probably will exclude them from important activities relating to dissolvable tobacco products and other subjects.”

As a prelude to the lawsuit, the complaint describes a flurry of correspondence regarding these potential conflicts between the plaintiffs and defendants from March 2010 through February 2011.  The complaint alleges violations of the Administrative Procedure Act, Food, Drug, and Cosmetic Act, and the Federal Advisory Committee Act.  The plaintiffs ask that the court prohibit the defendants from receiving or relying on any information or report issued by the TPSAC or the Constituents Subcommittee, enjoin the defendants from transmitting plaintiffs’ trade secret information to either committee, and require the participation of the non-voting members in matters that do not involve access to confidential information.