“On September 27, 2010, the subcommittee will receive a presentation and discuss the timelines and structure of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public health”
Questions:
Is the establishment of this subcommittee FDA’s response to CRE’s continual request to announce that TPSAC is going to write the menthol report and thus not work off an FDA draft?
Is this a new subcommitee analgous to the constituents subcommitee?
How have these members been vetted?
What are their backgrounds?
FACA requires that committees and subcomittees be “balanced”. Will FDA discuss at the TPSAC meeting how the subcommittee is balanced?.
Lastly, what assurance does the public have that an unbiased analysis will result from a panel who have worked their entire career in the public health arena? One such assurance is to appoint one or more mathematical statisticians who are outside the public health community to examine the initiation/cessation studies.
What is the source of this information? Has CRE discussed their questions with FDA before or during the establishment of the subcommittee?
Word on the street this evening is that the FDA did not notify the three industry representatives that meeting on menthol was scheduled. They found out about the meeting when they were contacted by members of the public who follow Federal Register notices.