Governance and DQA Compliance

During the August 30 meeting of the TPSAC Constituents ubcommittee ,  two members raised data quality questions.  The Chair, Dr, Samet asked whether  the criteria for designating constituents as harmful were replicable; Dr. Lauterbach made a similar comment regarding information being disseminated by the FDA with respect to testing guidance.

 The Data Quality Act might well be the only mechanism available to ensure that the FDA does not continue to dominate every facet of the proceeding. To this end, see the CRE statement at the meeting  which is attached below.

TPSAC Aug 30 Statement (r)

CRE continues to identify FDA/TPSAC  non-compliance with FACA.  Would senior career civil servants who are charged with ensuring FACA compliance permit such actions  for any products other than tobacco?

See the attached memorandum which explains in detail the reasons why the Constitutents Subcommitee is in violation of FACA. Hopefully, FDA will address these issues  administratively so as not to necessiate other corrective actions.

CRE’s objective is to make FDA aware of  its non-compliance with FACA so it will not make the same mistakes when it establshes the menthol subcommittee.

See CRE  coverage in  FDA Week