March 8th, 2010 Boston Globe Editorial: ``FDA Lax On Conflicts Of Interest''

Floor Speech

* Ms. FOXX. Madam Speaker, I would like to submit an editorial published in the Boston Globe on March 8, 2010, entitled ``FDA Lax on Conflicts of Interest.'' This editorial highlights the potential conflicts of interest inherent in the FDA's recent selection of Committee Members for their newly established Tobacco Products Scientific Advisory Committee, TPSAC. I understand the committee is responsible for advising the FDA on a broad range of topics, including nicotine levels in cigarettes and the development of reduced risk products.

* I opposed H.R. 1256, the Family Smoking Prevention and Control Act when it passed through the Democrat-led Congress in the summer of 2009 before being signed into law. The bill, which provided the FDA with the authority to regulate tobacco products, defies logic and I have been monitoring the development of these new regulations carefully. Earlier this month the FDA finally announced the members they selected to serve on TPSAC. Alarmingly, as the Boston Globe editorial explains, two of the scientists selected as committee members have direct financial ties to the companies who could benefit from the recommendations they will be tasked with making. Having committee members who stand to gain financially from their own recommendations is unacceptable and represents disturbing conflicts of interest. This action and the resulting conflicts of interest are extremely threatening to the tobacco industry--an industry that provides hundreds of thousands of jobs in North Carolina and throughout our nation.

* This Administration likes to talk about high ethical standards and transparency but we have yet to see those lofty promises put into action. The Administration can take its first step towards this goal by eliminating these conflicts of interest and ensuring the FDA takes the utmost precaution against selecting such members in the future.

FDA LAX ON CONFLICTS OF INTEREST
[From the Boston Globe, Mar. 8, 2010]

* The Food and Drug Administration has done far too little to avoid conflicts of interest among those who serve on its scientific panels and advisory boards. The latest example came last Monday, when the agency appointed to a tobacco advisory committee two scientists who have financial ties to companies that sell smoking cessation products.

* One of the scientists, Jack Henningfield, makes most of his income from a consulting company that has GlaxoSmithKline, which makes Nicorette gum, as a client, according to a Wall Street Journal report. The other, Neil L. Benowitz, formerly worked as a consultant for GlaxoSmithKline and still consults for Pfizer, which makes the quit-smoking drug Chantix.

* It could be worse. The pair of scientists could have financial ties to cigarette makers--which would violate federal law since the two will vote on recommendations for how to regulate the tobacco industry. But no matter how honorable the individuals involved, there's a clear danger when those who decide whether menthol cigarettes should be banned and whether smokeless tobacco products are safe also stand to profit from the sale of products that help people quit smoking.

* It's encouraging that the FDA asked the scientists to disclose their financial ties to the drug companies. The reason for their appointment is the same scientific expertise they also offer to the pharmaceutical industry. But the agency must justify why the nine voting members of the committee could not be selected from the many scientists who do not have such ties.

* If the two scientists are indeed the best that can serve the committee, they should not be allowed to vote on whether particular tobacco products can come to market unless they agree not to receive profits related to smoking-cessation aids. In addition, the FDA, which promised to screen all panel members for conflicts of interest before each meeting, should make the criteria and results of those screenings public while the panel meets and before any of its recommendations become national policy.

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