Governance and DQA Compliance

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