Center for Regulatory Effectiveness on FDA's Public Participation Program: Forcing the Public to Review Discredited Studies

WASHINGTON, Nov. 19, 2010 /PRNewswire/ -- Months ago, CRE concluded that:

1. Out of all the studies cited by the FDA regarding the health effects of menthol that the only end points of any potential significance dealt with smoking initiation/cessation.
2. The initiation/cessation studies identified by FDA could not be used by the FDA because they failed to meet the standards of the Data Quality Act.
3. As a result of CRE's numerous statements that the aforementioned studies were not DQA compliant, that the FDA would award a grant to an outside Federal Contractor not to do a new study but to perform a review of the literature that would be policy based not science based—meaning to identify any component of any existing study, however trivial, that could be used as propaganda by select numbers of TPSAC who had had already decided that the FDA should ban menthol.
4. The contractor which would be chosen by the FDA would be RTI International.
5. RTI International would direct Dr. Hersey to perform the "study."

It was for these reasons that CRE chose, out of the dozens of studies identified by the FDA, for its first review a study conducted by Dr. Hersey and published its results on April 29, 2010 and May 7, 2010.

CRE also requested the comments from Dr. Hersey on May 17, 2010

CRE had no response from either RTI International or Dr. Hersey.

This inaction on the part of RTI International and Dr. Hersey resulted in CRE filing a Data Quality petition with the FDA, which included a finding that Dr. Hersey's study was not Data Quality compliant.

Yesterday, some six months later, on November 18, the FDA announced that RTI International/Dr. Hersey was selected to manage an analysis of a number of previous studies concerning smoking initiation/cessation to be conducted by a number of institutions.

Compliance with the President's Open Government Initiative requires FDA not to out spend the public, but instead provide the public with definitive answers when the public responds to its requests for information.

Consequently in lieu of providing RTI International   with additional funds to develop talking points for select members of TPSAC, FDA should provide RTI International with funds to respond to the detailed analyses submitted by the public.  The studies should be released to the public by FDA, not RTI, to ensure that the said studies are compliant with the Data Quality Act.

CRE's work to date has not been in vain because we are pleased with the serious attention the FDA is giving to the aforementioned DQA petition filed by CRE and so noted in correspondence from the FDA to CRE.

For a text with live links please see http://www.thecre.com/tpsac/?p=761

SOURCE Center for Regulatory Effectiveness