[Congressional Record (Bound Edition), Volume 156 (2010), Part 4]
[Extensions of Remarks]
[Pages 4948-4949]
[From the U.S. Government Publishing Office, www.gpo.gov]




   MARCH 8TH, 2010 BOSTON GLOBE EDITORIAL: ``FDA LAX ON CONFLICTS OF 
                               INTEREST''

                                 ______
                                 

                           HON. VIRGINIA FOXX

                           of north carolina

                    in the house of representatives

                       Wednesday, March 24, 2010

  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

[[Page 4949]]

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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