[Congressional Record Volume 156, Number 47 (Wednesday, March 24, 2010)]
[Extensions of Remarks]
[Page E474]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




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

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                           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 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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