Less than one business day before the TPSAC meeting:
l. Who is on the menthol subcommittee?
2. Do any of the members of the subcommittee have a background independent of the public health community?
3. Are there any mathematical statisticians on the subcommittee?
4. Is FDA going to hire a consultant to review the initiation/cessation studies, give the operating instructions to the reviewer, package the analyses, reach conclusions and submit the findings to the menthol subcommittee for an up or down vote, and then claim that the process is FACA compliant because “FDA is not a member of the menthol subcommittee? ( This was the process used for the constitutents subcommitee.)
Editors Note: Committee membership now available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM227034.pdf
Question: Is membership on the menthol subcommittee limited to the names on the above list? Are there other non-voting members, particularly FDA staff as was the case with the consitutents subcommittee?
INDUSTRY REPS RULED OFF MENTHOL SUBCOMMITTEE
FDA has ruled that industry reps cannot be on menthol report writing committee as they may see something that the FDA would consider a trade secret or commercial confidential. FDA said that even if industry waived the rights of confidentiality, the FDA could still restrict the documents until it had reviewed them to its standards.
The industry reps were told they could go off and write their own report but there would be no guarantee if would be used or given to the TPSAC.
Does the FDA really want good science on the TPSAC?