At the beginning of the month, US District Court Judge, Richard Leon decided to allow a lawsuit against the FDA to move forward. The plaintiffs: tobacco giants R.J. Reynolds and Lorillard. The suit alleges conflicts of interest for the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC).
The TPSAC has been advising the FDA commissioner since its creation in June of 2009. The committee’s primary focus is providing regulatory advice where tobacco products are concerned. Committee members aren’t allowed to hold financial ties to the focus area of their committee. As such, none of the members are financially tied to tobacco companies. The problem is that at least 3 members are financially tied to pharmaceuticals companies which produce smoking cessation drugs.
This means that pharmaceutical interests might be protected by the FDA though various conflicts of interests. The culprits: committee members Jack Henningfield (paid consultant with GlaxoSmithKline), Neal L. Benowitz (paid consultant with GlaxoSmithKline and Pfizer), and TPSAC chair Jonathan Samet (recieved funding from GlaxoSmithKline).
The suit was filed in February of 2011 and this is its first break in some time. If the FDA is forced to reconstruct its tobacco committee, every decision made from its inception could be called into questions. Certainly, the way electronic cigarettes have been handled might raise a few questions. If the FDA protected cessation drugs from a far more successful alternative for the sake of its ties to Big Pharma, it may find itself unable to do anything to the industry moving forward.
Clearly, this is an area that could have a profound impact on the future of electronic cigarettes. We’ll be keeping an eye on this as things develop.