Judge Allows Challenge of FDA Tobacco Panel to Proceed

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Judge Allows Challenge of FDA Tobacco Panel to Proceed


RICHMOND, Va. -- A federal judge ruled today that a lawsuit alleging conflicts of interest in the Food and Drug Administration's (FDA) advisory panel's review of tobacco products can go forward, reports the Associated Press.

U.S. District Court Judge Richard Leon denied the FDA's motion to dismiss the lawsuit, filed last year by Lorillard Inc. and R.J. Reynolds Tobacco Co. The lawsuit 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, according to the report.

The panel advises the FDA on tobacco-related issues such as the public health impact of menthol cigarettes and dissolvable tobacco, growth areas for the industry.

"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.

"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," said Lorillard in a released statement.

The FDA has been able to regulate tobacco since 2009. It does not have to follow the advisory panel's recommendations, but usually does.

The lawsuit alleges that the panel does not meet federal requirements that committee members should be fairly balanced and not inappropriately influenced by any special interest, and 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.

The agency argued that the panel does meet federal standards and that the tobacco companies' "alleged injuries are entirely speculative," and "not fairly traceable." It also argued that the court does not have jurisdiction to review the conflict of interest challenge.

Several cigarette manufacturers, including non-plaintiff Altria Group Inc., parent company of Philip Morris USA, previously asked the federal agency to remove members of the panel for conflicts of interest.

Vince Willmore, spokesman for the Campaign for Tobacco-Free Kids, labeled the lawsuit an attempt to "obstruct effective policies to reduce tobacco use and to discredit anyone who advocates such policies."

The advisory panel issued two mandated reports in recent months. In March, the panel's report stated that removing menthol from the market would benefit public health because its flavoring has caused an increase in smokers and makes it harder to quit. However, it also stated that menthol smokers are not likely to be at higher risk of disease or exposed to more toxins. The FDA is conducting an independent review of the issue. Additionally, earlier this year the panel stated that dissolvable tobacco products could reduce health risks compared with smoking cigarettes but also could increase the overall number of tobacco users.