Judge: FDA can't use tobacco panel menthol report

Published on NewsOK Modified: July 21, 2014 at 7:43 pm •  Published: July 21, 2014
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RICHMOND, Va. (AP) — The Food and Drug Administration can't use an advisory panel's 2011 report on menthol cigarettes because its members had conflicts of interest, a federal judge ruled Monday.

While the agency has since conducted an independent review on the public health impact of menthol cigarettes, the ruling could hinder the FDA's ability to defend any future regulation of the minty smokes.

U.S. District Court Judge Richard Leon in Washington ordered the FDA on Monday to reconstitute the tobacco panel and barred the agency from using its older report on menthol cigarettes.

Cigarette makers Lorillard Inc. and Reynolds American Inc. sued the agency in 2011, alleging conflicts of interest and bias by several members of the panel tasked with advising the FDA on tobacco-related issues.

They argued that the panel failed to meet the federal requirements that committee members should be fairly balanced and not inappropriately influenced by any special interest. The lawsuit specifically alleged that some committee members had conflicts of interest because they were paid expert witnesses in anti-tobacco lawsuits and had financial ties to pharmaceutical companies that make smoking-cessation products.

The agency, however, argued that the panel met federal standards and that the cigarette makers' "alleged injuries are entirely speculative."

In his order Monday, Leon said the FDA erred in determining that the members didn't have conflicts of interest and therefore, the agency's appointment of those members was "arbitrary and capricious," and tainted both the panel and its work.

"Conflicts of interest — whether actual or perceived — undermine the public's confidence in the agency's decision-making process and render its final product suspect, at best," he wrote.

Dr. Jonathan Samet is the only remaining member of the Tobacco Products Scientific Advisory Committee challenged in the lawsuit. Samet, director of the University of Southern California's Institute for Global Health and former director of the Institute for Global Tobacco Control at Johns Hopkins University, serves as the panel's chair. He did not immediately respond to a request seeking comment.

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