Dr. Margaret Hamburg, the choice to be the agency’s chief, won accolades as New York City’s health commissioner during 1990s for mounting a vigorous program against drug-resistant tuberculosis and persuading then-Mayor David Dinkins to support needle-exchange programs to slow the spread of AIDS among drug addicts.
She also served in the Department of Health and Human Services under former President Bill Clinton, as a bioterrorism expert at the Nuclear Threat Initiative and as an official at the National Institute of Allergy and Infectious Diseases, where she aided the struggle to get AIDS drugs developed and approved.
Dr. Joshua Sharfstein, nominated to be deputy commissioner, observed the agency’s problems while working as an aide on health issues for Representative Henry Waxman and while serving as the head of Mr. Obama’s transition team for the FDA.
Health commissioner, his current job, he persuaded the FDA to restrict the use of over-the-counter cold medicines for young children because of severe complications and lack of evidence that they worked. He has the qualifications to run the agency, a valuable attribute in a deputy.
The two nominees will face daunting problems at the FDA, including a shortage of scientific expertise, antiquated information technology, failures to protect the public from defective medical devices and drugs, and gaping holes in its programs to screen imported products and find the sources of food-borne illnesses.
Strong leadership is essential. But to keep American consumers safe, the F.D.A. will also need more authority and a large increase in financing from Congress.