4 members on FDA tobacco advisory panel leave following court ruling on conflicts of interest



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RICHMOND, Virginia — Four members of Food and Drug Administration's tobacco advisory panel, including its chairman, have left after a federal judge ruled some of its members had conflicts of interest, the agency said.

Members of the Tobacco Products Scientific Advisory Committee were rescreened after the court ruling and either resigned or were removed from the panel responsible for advising the agency on tobacco-related issues, Mitch Zeller, director of the FDA's Center for Tobacco Products, said late Thursday in a statement.

In July, U.S. District Court Judge Richard Leon in Washington, D.C., ordered the FDA to reconstitute the panel and barred the agency from using its 2011 report on menthol cigarettes. The agency has since conducted its own review on menthol cigarettes, which concluded in 2013 that menthol cigarettes likely pose a greater public health risk than regular cigarettes. But it did not make a recommendation on whether to limit or ban them.

The ruling stemmed from a 2011 lawsuit by cigarette makers Lorillard Inc. and Reynolds American Inc., alleging conflicts of interest and bias by several members of the panel.

Many panels advise the FDA on scientific issues. The agency doesn't have to follow their recommendations but usually does.

Those no longer on the tobacco panel include Dr. Jonathan Samet, who served as chairman, as well as Claudia Barone, Joanna Cohen, and Suchitra Krishnan-Sarin.

Samet was the only remaining member of the panel 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, had previously received several grants from pharmaceutical maker GlaxoSmithKline and testified for lawyers suing tobacco manufacturers, according to court documents.

Their departure from the panel is a loss to the agency and for public health, Zeller said. And while there would be strong reasons for the agency to consider a waiver or authorization that would allow them to continue their service, in light of the ruling, Zeller said, "we do not believe we are able to exercise our discretion to consider this option at this time."


Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum.

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