Monday, March 16, 2009

More on the new Hamburg Sharfstein FDA

US President Barack Obama has named long-time industry critic Dr Joshua Sharfstein as principal deputy commissioner at the Food and Drug Administration (FDA). His choice to lead the agency is former New York City Health Commissioner Dr Margaret Hamburg.

Announcing Dr Hamburg's appointment on March 14, Pres Obama said that, in New York, she had “brought a new life to a demoralized agency, leading an internationally-recognized initiative that cut the tuberculosis rate by nearly half.” She will bring to her new role at the FDA “not only a reputation for integrity but a record of achievement in making Americans safer and more secure,” he added.

Dr “Peggy” Hamburg has not been generally touted as a front-runner for the top FDA post, left vacant in January by the resignation of Dr Andrew von Eschenbach. Her other previous posts include Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services, Assistant Director of the National Institute of Allergy and Infectious Diseases and founding Vice President of the Nuclear Threat Initiative’s Biological Program.

Her appointment has to be confirmed by the Senate but Pres Obama’s choice for her principal deputy does not. A pediatrician and health commissioner for the city of Baltimore, Dr Sharfstein conducted an assessment of the FDA for the Obama transitional team, but hit the headlines in 2007 with his attempts to get the marketing of over-the-counter (OTC) cough and cold medicines to children banned. He is “recognised as a national leader” for these efforts, said Pres Obama, adding: “and he’s designed an award-winning programme to ensure that Americans with disabilities had access to prescription drugs.”

Dr Sharfstein had been widely regarded as joint front-runner, with Cleveland cardiologist and fellow industry critic Dr Steve Nissen, to take over from Dr von Eschenbach, but neither doctor would have been the choice of industry. And responding to the appointments at the weekend, the Pharmaceutical Research and Manufacturers of America (PhRMA) praised Dr Hamburg’s managerial skills, but made no comment on Dr Sharfstein.

However, Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association (GPhA), said he “brings exceptional knowledge of what it takes to ensure the safety and efficacy of the medicines that Americans rely on to improve their health. His commitment to protecting the public health is stellar." Dr Hamburg is “an excellent choice” for FDA Commissioner, Ms Jaeger went on, adding: “now more than ever, FDA needs a strong, smart manager and Dr Hamburg answers that call.”

Dr Sharfstein’s current boss, Baltimore mayor Sheila Dixon, has called him “a superstar within my administration,” while House Energy and Commerce Committee chairman Henry Waxman, welcoming both nominees as “a team that has strong public health credentials and demonstrated management abilities,” added: “I have known Dr Sharfstein for almost 10 years. He is exceptionally intelligent, energetic, and has a deep understanding of public health. He will be a real asset to this Administration.”

By Lynne Taylor
PharmaTimes

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