Hamburg in as FDA chief

May 19, 2009 by MassDevice staff

President Barack Obama's nominee to lead the Food & Drug Administration, Margaret Hamburg, was unanimously confirmed last night by the U.S. Senate, according to news reports.

Hamburg, 53, has a wealth of public health experience. She’s received two degrees from Harvard and at 36 became New York City’s youngest health commissioner.

During her tenure in New York, she reduced tuberculosis rates by 46 percent between 1992 and 1997. She also supported a controversial needle exchange program to slow the spread of AIDS, increased childhood immunization rates and developed one of the first programs to prepare the public for a terrorist attack by anthrax or other bio-chemical weapon.

Hamburg’s not known to kowtow to higher authorities either. She challenged her boss, then-Mayor Rudy Giuliani, by summoning a health department aide to a City Council meeting whom Giuliani wanted canned. Arguing that science and not "wishful thinking" should drive AIDS education, Hamburg also publicly opposed an effort requiring AIDS educators to stress abstinence to city students, refusing to take a so-called "morality oath" in 1992.

The unanimous Senate vote came after weeks of behind-the-scenes wrangling by the device, drug, health and food lobbies, which were eager to see a more business-friendly, less consumer-friendly candidate take the helm of the federal watchdog.

Hamburg's deputy, Joshua Sharfstein, has been running the agency as acting head since her nomination in March. Sharfstein also has a long pedigree in safety and consumer issues.

Her confirmation hearing was pushed up as the Swine Flu epidemic gained steam. The outbreak likely eased partisan objections to her appointment, despite her support of hot-buttons like FDA oversight of tobacco.

Hamburg says her top priority will be improving food safety; she'll have more resources to do that if Congress approves Obama's request for a $300 million boost to the FDA's budget.

Food safety won't be her only concern. In April the agency required the makers of 25 Class III medical devices approved before 1976 to submit safety and effectiveness data, ahead of a review that could lead to mandates for more stringent clinical human trials of the devices.

And amid calls for more oversight of the devices industry and public pleas from within the agency for dramatic reforms, she'll be asked to ensure the safety of imports from China.

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