Lorillard Sues FDA

“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,” says Lorillard’s senior vice president.

Lorillard Inc. today filed suit to stop Food and Drug Administration (FDA) from receiving or relying on recommendations from its Tobacco Products Scientific Advisory Committee, including recommendations regarding the use of menthol in cigarettes.

Lorillard highlighted what it called conflicts of interest and bias among members of the committee. In the complaint, Lorillard also asked the Court to enjoin the FDA from making available to the advisory committee any trade secret or confidential commercial documents submitted by the company to FDA until the advisory committee is lawfully constituted.

The lawsuit was filed jointly by Lorillard and R.J. Reynolds Tobacco Co. in the U.S.  District Court for the District of Columbia. The advisory committee is expected to submit a non-binding recommendation on the use of menthol in cigarettes to the FDA by 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 Henningfield and Jonathan 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,” according to a press release by Lorillard.

“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 Milstein, senior vice president and general counsel of Lorillard.

The FDA noted that as a matter of general policy, it does not comment on possible, pending or ongoing litigation.

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