CRE Testifies Before FDA Tobacco Advisory Committee

CRE testified before the FDA Tobacco Advisory Committee.   The CRE testimony highlighted the FDA domination of the activities of the TPSAC.  To rectify FDA domination, CRE made three recommendations:

l.  Governance Procedures

CRE stated that TPSAC is an operating arm of the FDA since it reviews most significant issues before the FDA under the new tobacco statute, including every request under the reduced harm provisions of the statute.

Consequently public participation with the activities of the TPSAC should not be confined to the too infrequent TPSAC meetings.  To this end, TPSAC should publish for public comment the procedures to be  followed for public participation.

2.  Data Quality Compliance

The FDA is prohibited from using any of the reports of  TPSAC unless they are determined to be compliant with the Data ( Information) Quality Act. Consequently the FDA should  advise TPSAC of their responsibilites under the DQA.

3.  Public Participation

The activities of the TPSAC are too influential to be conducted with minimal participation by the public. At the same time CRE recognizes the time limitations of the TPSAC committee members.  It is for this reason that CRE has developed the concept of an Interactive Public Docket, such as this forum, to allow the public to interact with the TPSAC  on a 24/7 basis.

Consequently since this Interactive Public Docket: (1) accepts differing views on each topic under consideration and (2) makes all entries to the IPD public, this Forum complies with recent Open Government Directives sanctioned by the Administration.

Consequently the FDA should announce the availability of this discussion Forum to the public and TPSAC.

See the attachment below to read the FDA testimony before TPSAC.

Attached Files:

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