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Jill Wechsler is Pharmaceutical Technology's Washington Editor, email@example.com.
Washington, DC (Dec. 7)-One of the last acts of outgoing Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the Food and Drug Administration.
Washington, DC (Dec. 7)-One of the last acts of outgoing Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov). Frist had to invoke a seldom-used legislative procedure to overcome a number of “holds” on confirmation by fellow Senators with serious grievances against the agency. But in the end, the Senate strongly endorsed FDA’s new leader Dec. 7 with an 80-11 vote in favor of confirmation.
Von Eschenbach became acting head of FDA in September 2005 following the abrupt resignation of Lester Crawford from the job, and he was nominated to be commissioner last March (2006). Confirmation of the former director of the National Cancer Institute initially was delayed by Democrats angry about FDA refusal to approve an over-the-counter version of the emergency contraceptive pill Plan B. More recently, other Senators mounted protests over the sale of the abortifacient RU-486 and FDA opposition to importation of drugs from overseas. Sen. Charles Grassley (R-Iowa) was furious over FDA’s failure to provide all the information he demanded about possible fraud in clinical studies for the antibiotic Ketek.
The new commissioner will have to deal with these and myriad contentious issues as the official head of this high-profile agency, which has been attacked in recent years for lax oversight of drug safety, too-slow approval of new generic drugs, conflicts of interest among advisory committee members, and overly favorable treatment of Big Pharma. Von Eschenbach has weathered the drawn-out confirmation process by limiting his public comments to the need to spur innovation to reflect great progress in molecular biology, but he now will have to directly address these and other tough regulatory and legal issues. Inadequate agency funding and the need to renew the prescription drug user fee program are at the top of the list.
The confirmation opens the door to stability in the FDA Commissioner's Office: over the past decade, no commissioner has served for more than two years, prompting last September's Institute of Medicine report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, to note that “instability in the Office of the Commissioner has been a serious problem for FDA and CDER in particular. A large, complex, science-based regulatory agency cannot perform optimally in the absence of stable, capable leasdership and clear, consistent direction.” (1)
1. Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Assessment of the US Drug Safety System, The Future of Drug Safety: Promoting and Protecting the Health of the Public, A. Baciu, K. Stratton, and S.P. Burke, Eds (National Academies Press, Washington DC, 2006), www.iom.edu/CMS/3793/26341/37329.aspx, accessed on Sept. 28, 2006).