Menthol report barred over conflicts of interest within FDA advisory panel

A federal judge ruled yesterday that the US Food and Drug Administration cannot use an advisory panel’s 2011 report on menthol cigarettes because its members had conflicts of interest, according to a story by Michael Felberbaum for the ColumbusRepublic.

Felberbaum reported that while the agency had 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 such products.

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

Lorillard and Reynolds American 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.

The agency argued that the panel met federal standards and that the cigarette manufacturers’ ‘alleged injuries are entirely speculative’.

In his order, 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.