Hamburg, Sharfstein Picks For Fda Add Focus On Public Health
President Barack Obama picked Hamburg, 53, a former New York City health commissioner, as FDA commissioner, a person familiar with the decision said yesterday. Sharfstein, 39, is expected to be named deputy commissioner, another person said.
The agency for years has struggled with too few resources to be effective at policing drugs, medical devices and food under its oversight, said Dr. Ray Woosley, president of the Critical Path Institute, an Arizona-based nonprofit organization created by the FDA and the University of Arizona.
“The agency is regulating 25 percent of everything we touch every day and it has a budget that hasnt gone up in 20 years,” Woosley said yesterday in a telephone interview. “I think its just ludicrous that anybody would say the FDA is not doing its job. Of course its not.”
Woosley said Hamburg and Sharfstein would refocus the agency mission.
“The FDA is a public health agency and to have two public health leaders at the helm is a clear signal of the right direction for the agency,” said Woosley, whose center works to improve the approval process for products such as drugs.
Hamburg, a physician and bioterrorism expert, will face Senate hearings when she is formally nominated. If confirmed, she will take charge after a salmonella outbreak traced to peanut products led to nine deaths and sickened more than 660 people, and a year after the blood thinner heparin was recalled because it contained a deadly ingredient traced to China.
Full Review
Obama last month promised a full review of the FDA, which regulates products that account for $1 trillion in consumer spending and range from lipstick to heart stents. The agency has an annual budget of almost $2 billion and 11,000 employees.
Lawmakers such as Rep. Rosa DeLauro, a Connecticut Democrat who chairs an FDA appropriations subcommittee, say the agency needs more money. On Feb. 26, Obama proposed increasing the FDA budget for food safety to $1 billion, from $662 million in George W. Bushs request for 2009.
In recent years, the FDA also endured controversy over a delay in approving the over-the-counter contraceptive Plan B, withdrew the painkiller Vioxx in 2004 after it was linked to heart attacks, and has been criticized for failing to stiffen regulation of the use of the suspected toxin bisphenol A in baby bottles, cans and other products.
Failure to Modernize
Hamburg and Sharfstein, Baltimore health commissioner since 2005, should be able to repair Congress deep distrust and win more support, said Ian Spatz, director of the Rock Creek Policy Group, a Washington-based health industry consultant.
“Whats important for the FDA right now is that it has the confidence of key leaders of Congress and this certainly seems like a team that will have that confidence,” Spatz said in a telephone interview.
The pair served on Obamas transition team for the Department of Health and Human Services.
Public Health, Neuroscience
Hamburg has experience in neuroscience, drug research and public health. As New York Citys health commissioner from 1991 to 1997, she ran a large bureaucracy and created several innovative public health programs.
Hamburg also has worked within the federal health bureaucracy, researching AIDS at the National Institutes of Health and later as an assistant secretary at the Health and Human Services Department, where her responsibilities included strategic planning and the development and review of regulations. She sits on the board of Henry Schein Inc., a Melville, New York, distributor of medical products and services, including software.
Sharfstein gained attention in March 2007 by petitioning the FDA to ban the marketing of over-the-counter cough and cold drugs to children younger than age 6 because of the risk of side effects and lack of proven benefits. His 1 1/2-year fight prompted companies last October to warn against use by infants and toddlers.