FDA Scientific Advisory Panel Conflicts of Interest Remain

ALG Renews Call for FDA to Dismiss Science Panel Members With Conflicts

July 13th, 2010, Fairfax, VA—Americans for Limited Government (ALG) President Bill Wilson today called upon the Food and Drug Administration to reconsider the composition of a key science panel set to issue recommendations on tobacco regulations.

According to Wilson’s letter to FDA Commissioner Margaret Hamburg, “nearly a majority of the TPSAC voting members have received payments from special interests with billions of dollars riding on the outcome of the committee’s analysis.”

Wilson asked Hamburg to “reconsider the composition of this committee, either dismissing the conflicted members or requiring them to abstain from issues affecting their own financial interests.”

Wilson said four members of the committee have “clear conflicts of interest”. They are:

• Jack Henningfeld a voting member of the committee is a consultant to GlaxoSmithKline the maker of Nicorette gum who would stand to benefit financially from further restrictions on tobacco products

• Neil L. Benowitz was Pfizer consultant which makes the drug Chantix that aids people who want to quit smoking. Benowitz has also worked for GlaxoSmithKline and Nabi Pharmaceuticals

• Dorothy Hatsukami received grant support from Nabi Pharmaceuticals to study their nicotine vaccine

• The head TPSAC, Jonathan Samet, also received grants from GlaxoSmithKline and the organization he headed was funded by two different pharmaceutical companies

The law establishing the committee specifically states that the “membership of the advisory committee to be fairly balanced in terms of the points of view represented and the functions to be performed by the advisory committee;” and that the committee “contain appropriate provisions to assure that the advice and recommendations of the advisory committee will not be inappropriately influenced by the appointing authority or by any special interest, but will instead be the result of the advisory committee’s independent judgment.”

Previously, the FDA had rejected the dismissal of the members, but Wilson’s letter urged reconsideration. The letter notes that the FDA “said it would continue to screen members for potential conflicts of interest on topics the committee would be considering. We can envision no greater conflict. We urgently request that you revisit these disqualifying conflicts of interest.”

In a statement, Wilson concluded, “It is up to the FDA to follow the law and to remove even the appearance of a conflict of interest from a ‘science’ committee tasked to investigate the regulation of tobacco products. Right now, the committee is skewed by anti-tobacco industry interests.”

Attachments:

ALG Letter to FDA, July 13th, 2010 at www.getliberty.org/files/ALGLettertoFDA.pdf .

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