FDA Makes Landmark Improvements in TPSAC Governance

Today, among other changes, FDA announced the following actions regarding the process to govern the operation of the menthol Subcommittee of TPSAC:

 1.  “FDA will not write any portion of the report.”

  2.  “The drafts-in-progress are to be kept confidential and cannot be shared with anyone other than the chair, DFO and the science writer.”

  3. “FDA will review the new information and present it, as appropriate, at a TPSAC meeting for discussion.”

 CRE applauds the FDA for the above actions.

  Several topics raised at today’s meeting are in need of additional discussion:

 l. Time Extension

Given the very significant task facing the Subcommittee, CRE agrees with the position of one TPSAC member that Committee be given additional time to prepare the report past the scheduled, March 23, 2011 date.

 2. Interim Report

Another member of the Subcommittee suggested that if the March 23 date is not modified that the Committee issue an “interim” report with a subsequent report issued as the science advances. CRE notes that this is possible because the underlying statute does not specify a date certain by which FDA must act on menthol.

3.  Industry Participation

Questions were raised concerning the role that the non-voting industry members would play in the preparation of the report of the subcommittee. FDA was referring the matter to Counsel. CRE does not believe that either the statute or its legislative history speaks to this subject.

4.  Policy versus Science

Questions were raised as to whether the subcommittee report should address policy or science. The Data Quality Act mandates that policy decisions be separate from science. Accordingly, CRE believes that the Subcommittee should address scientific issues.

5.  Invoking the Precautionary Principle

One committee member suggested that if the science is uncertain, the precautionary principle should be invoked. Introducing the precautionary principle during the scientific evaluation would be a violation of the Data Quality Act.

Decisions taken on the aforementioned items could well determine the outcome of the report.

Please express your views on these topics by posting them at  http://www.thecre.com/dqa

Your comments  and detailed  analyses  posted on this  Interactive Public Docket will  be  incorporated into  a “public docket” which will  provide  the basis  for  demanding  further modifications to  TPSAC  procedures.

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