FDA Commissioner-Nominee Hamburg Would Face 'Several Crises' At Start Of Tenure, Wall Street Journal Reports

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health
Article Date: 18 Mar 2009 - 4:00 PDT

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Margaret Hamburg, whom President Obama has nominated as FDA commissioner, would face "several crises at the beginning of her term," as congressional lawmakers have the agency under investigation on "multiple fronts," the Wall Street Journal reports. In recent years, FDA has faced problems related to imported medications, nationwide salmonella outbreaks and complaints from agency scientists about the process used to make regulatory decisions.

According to the Journal, Hamburg "encountered a similar rush of problems" when she took over the New York City Health Department in 1991. She faced an epidemic of tuberculosis and a significant increase in the number of HIV/AIDS cases in the city and was "credited with aggressive actions" to address the issues, the Journal reports.

Tara O'Toole, director of the biosecurity center at the University of Pittsburgh, said that, as city health commissioner, Hamburg "kicked down the door if she wanted something done." University of Miami President Donna Shalala, who in 1997 as HHS secretary recruited Hamburg as an assistant secretary, said, "Peggy is perfect for this job. She is strong and won't be rolled over."

Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers or America, said that Hamburg "brings managerial skills that are essential for directing science-based activities." House Energy and Commerce Committee ranking member Bart Stupak (D-Mich.) said, "It is no longer a matter of if the FDA will be reformed, but rather a matter of when and how," with Hamburg as agency commissioner (Mundy, Wall Street Journal, 3/17).

More Appointees Needed
In related news, the Journal recently examined how the Obama administration "needs more key people in place to advance its ambitious agenda" on health care and other issues. According to the Journal, although "Obama has strewn hundreds of handpicked staffers throughout key agencies" and departments, such as HHS, "an unusually high number of them are designated as counselors or advisers, limiting their policy clout and keeping them largely out of the public eye."

At HHS, the Obama administration has hired 26 staffers, but the top positions at the department remain vacant as nominees await Senate confirmation. Senate Finance Committee staffers said that confirmation paperwork has not arrived for Kansas Gov. Kathleen Sebelius (D), whom Obama has nominated as HHS secretary. However, "HHS officials insist they are steaming ahead on the strength of career staff and strong White House guidance," the Journal reports (King/Power, Wall Street Journal, 3/16).

Editorials

• Baltimore Sun: Baltimore Health Commissioner Joshua Sharfstein, whom Obama has nominated as FDA principal deputy commissioner, is "a major plus for President Barack Obama," a Sun editorial states. Sharfstein has "shown the kind of creative leadership that should shine at the FDA," and his "sharp mind, can-do attitude and affable manner should serve him well in Washington," according to the editorial (Baltimore Sun, 3/15).
  
  
• Los Angeles Times: "This country must reform its ineffective food safety system," and "we welcome President Obama's naming of two consumer-minded leaders to head" FDA, "his creation of a panel to examine ways of streamlining food safety procedures now spread among several agencies and his support for more frequent inspections," according to a Los Angeles Times editorial. The editorial states, "Ensuring a wholesome food supply is one of the government's most basic responsibilities, necessary to the long-term health of its people and one of this nation's leading industries," adding, "The price the president outlines is high, but the cost of tweaking the system rather than overhauling it is far higher" (Los Angeles Times, 3/17).
  
  
• New York Times: "Obama has made two sterling choices to lead the embattled" FDA, as both Hamburg and Sharfstein "have the skills and experience to repair the damaged agency and restore its ability to protect American consumers," a New York Times editorial states. However, the two nominees "will face daunting problems at the FDA," and the agency will "need more authority and a large increase in financing from Congress" to address those issues, according to the editorial (New York Times, 3/17).

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