Center for Regulatory Effectiveness Calls for FDA Advisory Committee Independence

Saturday, July 17, 2010 Alcohol & Drug Abuse News J E 4

Concerns that Tobacco Advisory Panel Unduly Influenced by Agency

WASHINGTON, July 16 /PRNewswire-USNewswire/ -- The watchdog group Center for Regulatory Effectiveness (CRE) today urged the Commissioner of the Food and Drug Administration (FDA) to assure that advice provided by a tobacco advisory committee on menthol cigarettes is "independent and not influenced by agency staff" in accordance with federal law.

Jim Tozzi, a member of the Board of Advisors of the CRE, said that the Federal Advisory Committee Act includes provisions to ensure that committee recommendations are not unduly influenced by the agency. "I do not make this recommendation in an insular setting," Tozzi said. "I have participated in advisory committee activities for nearly two decades and I have never worked off a draft report prepared by a federal agency."

Tozzi expressed concern that FDA staff will develop a draft report for the FDA's Tobacco Products Scientific Advisory Committee. In testimony to TPSAC, he urged the Committee to "make a public declaration that the Committee is going to write the report on menthol without the use of a draft report prepared by the FDA."

Following passage of a new tobacco law last year, the FDA formed the advisory committee, which earlier this year began a set of hearings to examine menthol in cigarettes. The Committee could recommend that the FDA ban menthol cigarettes.

Tozzi also asked that the Committee give special emphasis to complying with a provision of new tobacco law that requires consideration of whether a ban would create a significant demand for contraband menthol cigarettes. Tozzi said the Center for Regulatory Effectiveness has information documenting the creation of black markets and will provide an in-depth analysis of the issue through a public positing on its Interactive Public Docket, which is located at

Tozzi is a former Assistant Director of OMB and was the career official in charge of OMB regulatory review for four US Presidential Administrations. He was also key to the passage of the landmark Paperwork Reduction and Data Quality Acts.

SOURCE Center for Regulatory Effectiveness


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