The FDA has taken the unprecedented action in submitting a petition filed under the Data (Information) Quality Act to an advisory committee. CRE applauds this action.
As the Chairman of TPSAC has stated on a number of occasions, TPSAC is a scientific advisory committee not a policy committee.
The standards for review in the DQA are not open to discussion; data underlying federal government regulatory actions must be reproducible, objective and unbiased. The decision of the DC Circuit Court in Prime Time declared that the DQA guidelines are binding on agencies. The DQA precludes the intrusion of policy preferences into scientific risk assessments.
CRE reviewed a number of the major studies identified by the FDA dealing with menthol and smoking initiation/cessation and concluded they were not DQA compliant. Based on the CRE review, CRE filed a DQA petition to the FDA asking them to prohibit the use of the said studies in developing a scientific assessment of the menthol.
CRE is encouraged that under existing law the TPSAC review of the CRE DQA petition must be founded on scientific analyses not policy preferences— it is important to note that the aforementioned views of the Chair are grounded in a federal statute.
Although the TPSAC can make a recommendation to FDA, by law, FDA must make the final decision on the CRE DQA petiton.
The precedent established by the FDA referral of the DQA petition to TPSAC is far greater than the action in itself; more importantly the referral:
(1) Demonstrates the critical and continuous role TPSAC will have in the regulation of tobacco, and
(2) Defines the level of commitment to scientific integrity in all future actions taken by the FDA with respect to the regulation of tobacco.