пятница, 3 августа 2012 г.
Federal judge says cigarette makers' suit over FDA tobacco review panel can move forward
A challenge by two of the nation's largest cigarette makers alleging conflicts of interest in the Food and Drug Administration advisory panel's review of tobacco products can move forward, a federal judge has ruled. In an order posted Wednesday, U.S. District Court Judge Richard Leon in Washington denied the FDA's motion to dismiss the suit filed by Lorillard Inc. and R.J. Reynolds Tobacco Co. The suit filed last year alleges financial conflict of interest and bias by several members of the Tobacco Products Scientific Advisory Committee and asks the court to stop the federal agency from relying on the panel's recommendations.
The panel is tasked with advising the FDA on tobacco-related issues, including the public health impact of menthol cigarettes and dissolvable tobacco, two industry growth areas. "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 which I can evaluate the agency's discretion," Leon wrote in his order. Representatives for the FDA and R.J. Reynolds would not comment on pending litigation.
In a statement, Lorillard said: "The practice of appointing members to a government scientific advisory committee who have financial interests that violate conflict-of-interest laws and regulations should be subject to judicial review, as the court has now recognized." The FDA won the authority to regulate tobacco in 2009. The law doesn't let the FDA ban nicotine or tobacco, just regulate what goes into tobacco products, require the ingredients be publicized and limit how tobacco is marketed, especially to young people.
The agency's panels advise it on scientific issues. It doesn't have to follow their recommendations, but usually does. In the suit, the tobacco companies allege that the panel fails to meet the federal requirements that committee members should be fairly balanced and not inappropriately influenced by any special interest. The suit specifically alleges that some committee members have conflicts of interest because they were paid expert witnesses in anti-tobacco lawsuits and have financial ties to pharmaceutical companies that make smoking-cessation products.
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