Governance and DQA Compliance

The Rest of  the Story

Today I announce the 3rd place finisher in my annual Liar, Liar, Pants on Fire Award for the worst public lie in the tobacco control field in 2011 (the Liar, Liar, Pants on Fire Award name is borrowed from PolitiFact, which uses the term in its truth-o-meter). The runner-up and winner will be announced in subsequent days.
Third Place – 2011 Liar, Liar, Pants on Fire Award: The World Medical Association

On October 4, 2011, the World Medical Association issued a press release in which it claimed that the tobacco industry was promoting electronic cigarettes in … Continue Reading

 In an August 8 letter, attached hereto, to Dr. Deyton of the Center for Tobacco Products, CRE explains in detail the reasons that the FDA peer review fails to comply with the peer review guidelines mandated by the Data Quality Act.

CRE concludes that the FDA must take the following actions to come into compliance:

1.  The agency must inform the public of how it can comment on the peer review plan and must consider any public comments.

2.  Unless the agency specifically determines that it is not feasible and appropriate to do so, it must revise the peer review plan to state … Continue Reading

http://www.thecre.com/tpsac/?p=1460

Attached below is CRE’s letter to the Chief Counsel of the Food and Drug Administration.

contrabandlettertoChiefCounsel

December 21, 2010 marks the tenth anniversary of the Data Quality Act (DQA), also known as the Information Quality Act, 44 U.S.C § 3516, note.

The DQA has deep roots developed over nearly a half-century as the result of a seed planted during the Johnson Administration which germinated in the Nixon Administration, was watered by the Carter Administration and whose product was harvested by the Reagan Administration, made available to the public in the Bush I Administration and subsequently enhanced by the Clinton Administration and promoted by the Bush II and Obama Administrations. See: http://thecre.com/ombpapers/SystemsAnalysisGroup.htm and http://thecre.com/quality/20010924_fedinfotriangle.html

The FDA has released   material its October  meeting.

The FDA material references initiation and cessation studies. The overwhelming number of these studies were reviewed in detail by the  CRE DQA petition.

 Should not the CRE DQA petition be reviewed by TPSAC as part of its review of the studies identified by FDA?

Is the TPSAC going  to  submit  a  report  which complies with the DQA or is going to ignore the statute and send a report which the FDA can not use?

What is the role of the non-voting tobacco representatives in the preparation of the report?

The Center for Regulatory Effectiveness (CRE) has notified the  FDA that  the smoking initiation/cessation studies identified by the FDA and reviewed by CRE can not be used to formulate a policy on menthol cigarettes.

 The Data Quality Act  prohibits federal agencies from using studies that are non-compliant with the DQA. The  FDA has sixty days to respond to the CRE petition.

 In its petition  CRE  painstakingly reviews eight of the studies identified by  the FDA and explains  the reasons for their non-compliance with the Data Quality Act.

 In its petition CRE states:

The Center for Regulatory Effectiveness , a regulatory watchdog managed by former White House Office of Management and Budget regulatory officials , has issued a scathing report on FDA non-compliance with the Federal Advisory Committee Act (FACA).

 Central to CRE’s arguments is the fact that FDA is dominating the advisory committee by controlling the production of key studies. CRE has called these illegal actions to the attention of FDA a number of times but FDA continues to act outside the law because they conclude that since the product in question is tobacco that the normal rules of … Continue Reading

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