UNITED STATES
Lorillard, Reynolds sue FDA

Lorillard and RJ Reynolds Tobacco today jointly filed a lawsuit against the Food and Drug Administration (FDA) charging there were "conflicts of interest and bias among members" of the FDA advisory panel.

The suit says three members of the Tobacco Products Scientific Advisory Committee – Drs. Neil Benowitz, Jack E. Henningfield and Jonathan M. Samet – have received funding for research or consultation work from drugmakers that make smoking-cessation products.
In a press release Lorillard states it filed the suit to stop the FDA from receiving or relying on recommendations from the advisory committee, including recommendations regarding the use of menthol cigarettes.
Lorillard also asks 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 suit, filed in the US District Court for the District of Columbia, 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 advisory committee is expected to submit a non-binding recommendation on the use of menthol in cigarettes to the FDA by 23 March 2011. (pi)

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