Center for Regulatory Effectiveness Asks: Academy Awards at FDA's TPSAC?

WASHINGTON, Sept. 24 /PRNewswire/ -- Less than one business day before the Tobacco Products Scientific Advisory Committee reviewing menthol in cigarettes:

1. Who is on the menthol subcommittee?

2. Do any of the members of the subcommittee have a background independent of the public health community?

3. Are there any mathematical statisticians on the subcommittee?

4. Is FDA going to hire a consultant to review the initiation/cessation studies, give the operating instructions to the reviewer, package the analyses, reach conclusions and submit the findings to the menthol subcommittee for an up or down vote, and then claim that the process is FACA compliant because "FDA is not a member of the menthol subcommittee?"

The Center for Regulatory Effectiveness is a regulatory watchdog founded by former officials of the White House Office of Management and Budget. See http://thecre.com/ombpapers/OMB_Officials.htm

CRE was the original proponent of the Data Quality Act which requires that Federal Regulations be science-based, see http://www.thecre.com/quality/2009/20091231_quality.html

SOURCE Center for Regulatory Effectiveness

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