U.S. FDA - loses two top members - Connolly/Sharfstein..

January 6, 2011 - The Food and Drug Administration (FDA) has lost an adviser to the Tobacco Products Scientific Advisory Committee (TPSAC) as well as its number two official.


A member of the TPSAC, a key tobacco-advisory committee for the Food and Drug Administration, who faced criticism from the industry says he stepped down because he can be more helpful to the agency as an outsider. Gregory N. Connolly, a Harvard School of Public Health professor and tobacco researcher, said that he resigned about three weeks ago for "personal reasons" and because he could be "more effective off the committee than on it".

Connolly said he wasn't pushed to resign, though "I didn't have as many friends as one would like" within the FDA. He also said his decision had nothing to do with Philip Morris USA's effort last year to have him and three other members of the advisory committee removed on the grounds that they had extensive conflicts of interest. The agency rejected the Altria Group unit's request early last year.

An FDA spokesman said Wednesday, January 5th that Connolly resigned and that "his departure will not impede the schedule or progress of" the Tobacco Products Scientific Advisory Committee. He declined further comment.

Connolly's apparent departure comes a few months before the panel is scheduled to issue a report on an issue crucial to the tobacco industry - whether menthol cigarettes should be banned. The FDA doesn't have to follow the panel's recommendation and faces no deadline to act. Menthol smokes account for about 30 per cent of industry sales.

More on the defense of menthol - the Tobacco Industry..

Morgan Stanley analyst David Adelman, in a research note, said Connolly's departure makes him more confident that the FDA will ultimately decide not to ban menthol as a cigarette flavouring. Connolly's absence "removes an individual who was the dominant anti-tobacco voice in the menthol hearings so far", Adelman wrote. The issue is of paramount importance to Lorillard, the maker of leading menthol brand Newport. The product accounts for roughly 90 per cent of the Greensboro, NC, company's sales.

Lorillard - essentially a one-product company - Newport cigarettes.. Lorillard cannot do what some competitors have done and focus on overseas for growth. In 1977 Lorillard sold the rights for international sales of its cigarette brands to British American Tobacco (BAT). (TobaccoWatch.org)

Furthermore, FDA Deputy Commissioner Joshua Sharfstein, 41 years old, the FDA's number two official, is leaving the agency after a busy 21-month tenure that included clashes with drug and device makers over tougher regulation. He is taking the top public-health job for the state of Maryland, a spokesman for Maryland's governor said, with an announcement scheduled for Wednesday. Sharfstein led the FDA's campaign against e-cigarettes. (U.S. FDA files new appeal in e-cigarette lawsuit..)

Reference: FDA loses two top members, Tobacco Journal International, 1/5/2011.