Center for Regulatory Effectiveness Calls for FDA Advisory Committee Independence

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.”

Lorillard Urges FDA to Review Testimony on Menthol

July 13 (Bloomberg) — Lorillard Inc., the largest U.S. maker of menthol cigarettes, is urging regulators to review testimony by some government scientists indicating the mint flavor makes cigarettes more harmful.

The Food and Drug Administration began examining the health impact of menthol in cigarettes in March, and a new round of hearings on the matter begins this week.

“We are looking for accuracy along the way,” William True, Lorillard’s senior vice president of research and development, said yesterday in an interview. “There will be much more this week in terms of quantifiable, measurable science.”

Could FDA Panel Conflict of Interest Endanger Menthol Cigarettes?

By Paul Bedard, Washington Whispers

At least four groups are now questioning the credibility of a federal advisory panel created to study tobacco product safety, challenging two members with financial ties to drug firms that make smoking cessation products. At issue: Will the duo push to ban menthol ciggys and favor smokeless products?

The issue hit this week when the Center for Responsibility and Ethics in Washington, or CREW, filed a complaint against the FDA’s tobacco advisory panel for conflicts of interest since they have voting members who consult for pharmaceutical companies that work on nicotine delivery products to quit smoking.

TPSAC Subcommittee Meeting July 7 and 9

 

Tobacco Product Constituents Subcommittee of the Tobacco
Products Scientific Advisory Committee.

Date and Time: The meeting will be held on July 7, 2010, from 8:30 a.m. to 5
p.m. and on July 8, 2010, from 8 a.m. to 5 p.m.

See attachment

More on CREW’s call for an investigation of Tobacco Products Scientific Advisory Committee

Submitted by crew on 7 June 2010 – 4:19pm.

Earlier today, CREW sent a letter to the Inspector General at the Department of Health and Human Services (HHS) calling for an investigation into the appointments of two members of the Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC).

The Hill provided coverage of our request for an investigation:

The good government group Citizens for Responsibility and Ethics in Washington (CREW) wants the Food and Drug Administration to drop two members of its advisory panel on tobacco products for what it calls “clear financial conflicts of interests.”