Alleging conflicts of interest among members of the Food and Drug Administration (FDA) scientific advisory committee, Lorillard filed suit to stop FDA from receiving or relying on recommendations from their advisory committee – called tpsac – including proposals regarding menthol cigarettes. The lawsuit was filed jointly by Lorillard and R.J. Reynolds Tobacco Company in the United States District Court for the District of Columbia. The TPSAC advisory committee is expected to make a recommendation on menthol cigarettes on March 23, 2011.
The suit alleges that the Tobacco Products Scientific Advisory Committee as currently constituted fails to meet requirements of the Federal Advisory Committee Act to be fairly balanced and not to be inappropriately influenced by any special interest. Instead, the suit alleges, conflicts of several members of the committee render the panel unable to deliver any report or recommendation to the FDA that is “free of the taint of conflicts of interest.”
The suit specifically alleges that three members of the committee, Drs. Neil Benowitz, Jack E. Henningfield and Jonathan M. Samet are conflicted because they have made tens of thousands of dollars as paid expert witnesses in litigation against tobacco products manufacturers and due to their continuing financial relationships with pharmaceutical companies that make smoking-cessation products.
Beginning last year, the two companies and others urged the FDA to ensure that members of the panel were free of conflicts. Those concerns, however, were either summarily rejected or entirely ignored.
“We are taking this action reluctantly after the FDA failed to constitute the committee in accordance with the law and failed to properly address legitimate concerns regarding fairness and impartiality,” said Ronald S. Milstein, senior vice president and general counsel of Lorillard.