Reynolds Suit Challenging FDA Panel Members Can Proceed

R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co. can proceed with a lawsuit that seeks to block U.S. regulators from using an advisory panel’s report because of its alleged conflicts of interest.

U.S. District Judge Richard Leon in Washington today denied a request by the Food and Drug Administration to dismiss the case, ruling he has authority to evaluate whether the committee’s members “represent a fair balance of viewpoints” on regulation of tobacco products.

“Because of the limited number of viewpoints on these issues, the scientific -- as opposed to political -- nature of those viewpoints, and the distinct responsibilities of the committee, I believe I have sufficient standards against which I can evaluate the agency’s discretion,” Leon said in his ruling.

Reynolds and Lorillard, the second- and third-biggest U.S. cigarette makers, filed the complaint in February 2011. They sought an order to prevent the FDA from drawing on reports by the Tobacco Products Scientific Advisory Committee, including one on menthol in cigarettes.

Three of the eight committee members “have severe financial and appearance conflicts of interest and associated biases,” the companies said in their complaint. The three members serve as paid expert witnesses in lawsuits against the tobacco industry and take money from drug companies that make nicotine-replacement products and other smoking-cessation aids, according to the complaint.

‘Similar Viewpoints’

The voting membership of the panel is “dominated by a clique of people with similar viewpoints on smokeless tobacco and other matters, including matters on which they have jointly published articles, and thus does not reflect the diversity of views on tobacco-related issues among the members of the public-health and tobacco-control communities,” according to an amended complaint.

Reynolds, a unit of Winston-Salem, North Carolina-based Reynolds American Inc., makes Camel and Winston cigarettes in addition to its Kool and Salem menthol brands. Lorillard Tobacco is a unit of Lorillard Inc., based in Greensboro, North Carolina. It makes Newport, the top-selling menthol brand.

Jennifer Haliski, an FDA spokeswoman, said the agency doesn’t comment on ongoing litigation.

Industry Consultants

The Tobacco Control Act, which authorized the FDA to regulate the tobacco products in the U.S., requires that none of the panel’s voting members include a representative from the tobacco industry, according to the agency’s motion to dismiss. The law allows for three industry representatives to serve as consultants to the committee.

“In this lawsuit, Lorillard and R.J. Reynolds preemptively attack TPSAC in an effort to nullify its advice on menthol cigarettes, prevent it from working on dissolvable tobacco product issues, and force the removal of prominent public health experts whose views the manufacturers oppose,” Patrick Nemeroff, a Justice Department lawyer, said in its filing requesting the lawsuit be dismissed.

Leon, appointed to the bench by President George W. Bush, found another part of the law to be unconstitutional. He ruled Feb. 29 that requiring all cigarette packages to display images such as diseased lungs and a cadaver with chest staples on an autopsy table violated the companies’ First Amendment rights.

The FDA appealed that ruling to the U.S. Court of Appeals in Washington, which has yet to issue a decision.

The case is Lorillard Inc. v. U.S. Food and Drug Administration, 11-cv-00440, U.S. District Court, District of Columbia (Washington).

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