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Drug Makers, Consumer Groups Push Candidates to Head Up FDA

Nov 7, 2008 | Parker Waichman LLP

Dr. Janet Woodcock, current head of the Food & Drug Administration's (FDA) drug division, is said to be a drug industry favorite to head up the agency in a new Obama Administration.  However, consumer advocate groups are said to be favoring agency critics like Dr. Stephen Nissan and Baltimore City's health commissioner, Joshua Sharfstein.

Current FDA Commissioner Andrew von Eschenbach has said he will offer his resignation before President-Elect Obama takes office in January.  The current commissioner has been criticized as being too hands-off in his leadership.  Meanwhile, over the past 8 years, scandals involving drugs like Vioxx and heparin, dangerous side effects from other medicines, plus recalls of peanut butter, spinach and other foods, hurt the FDA’s reputation.

Woodcock has been at the FDA since 1986.  Before heading up the drug division in March, she served as deputy commissioner and chief medical officer. According to, representatives of drug makers are advocating to lawmakers that Woodcock be chosen to serve as commissioner on either an acting or permanent basis. Woodcock is also  among a number of candidates supported by Ellen Sigel, chairwoman of Friends of Cancer Research, based in Arlington, Virginia. The group receives some funding from drug makers.

Advocacy groups and critics of the FDA, however, have questioned whether Woodcock would get the job, saying she wouldn't be seen as someone who would significantly change the agency.  While she wouldn't comment on any possible FDA candidate - including Woodcock - directly, Representative Rosa DeLauro, a Connecticut Democrat, and frequent FDA critic, told ``You need to have someone who changes the culture at the agency.''

Several consumer groups, including the National Research Center for Women & Families, are said to favor cardiologist Stephen Nissen.  Nissen disclosed heart risks associated with the diabetes drug Avandia in a May 2007 study, and he has criticized the agency's handling of drug safety.  However, Nissen would likely face strong opposition from the drug industry.

Joshua Sharfstein is another favorite of consumer groups.  He  gained prominence last year after petitioning the FDA to ban marketing of over-the-counter cough and cold medicines marketed to young children.

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