March 1, 2011 -
R.J. Reynolds Tobacco Co./Lorillard Tobacco Co. sued to block FDA TPSAC menthol recommendations..
From the FDA Law Blog..
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 defendants: 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 plaintiffs (R.J. Reynolds Tobacco Co./Lorillard Tobacco Co.) 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.
Reference: Lawsuit Alleges Bias and Conflicts of Interest in FDA’s Tobacco Products Scientific Advisory Committee by David B. Clissold, FDA Law Blog, 2/28/2011.