March 12 (Bloomberg) -- The choices of Margaret A. Hamburg and Joshua Sharfstein to run the U.S. Food and Drug Administration puts the country’s health regulation in the hands of two doctors with a history of guarding public safety, a duty the agency has been criticized for neglecting.

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 hasn’t gone up in 20 years,” Woosley said yesterday in a telephone interview. “I think it’s just ludicrous that anybody would say the FDA is not doing its job. Of course it’s 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. Bush’s 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

“It’s essentially a relic of the 19th century,” former FDA associate commissioner William Hubbard told Congress yesterday.

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.

“What’s 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 Obama’s 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 City’s 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.

Drugmakers and Doctors

Sharfstein also has criticized drugmakers over distributing gifts to doctors. In his first year at Harvard Medical School in 1992, he organized a drive for his fellow students to return textbooks paid for by Novartis AG’s generic-drug unit Sandoz. He also wrote a letter to the editor of the New England Journal of Medicine in 1997 complaining about Pfizer Inc. sponsoring a beer and billiards night for doctors in Boston.

Hamburg comes from a family steeped in medicine. Her mother, Beatrix, was the first black woman to attend Vassar College and the first to earn a medical degree at Yale University, according to the National Library of Medicine. Her father, David, also a physician, headed the Institute of Medicine, an arm of the nonprofit National Academies of Science that offers science-based advice on health issues, from 1975 to 1980.

As New York’s health commissioner, Hamburg designed a tuberculosis control program that reduced New York’s TB rate by 46 percent between 1992 and 1997, and by 86 percent for the most resistant strains, according to the National Library of Medicine. She also developed initiatives that raised childhood immunization rates to record levels, and created the first program in the U.S. to help the public prepare and respond in the event of a terrorist attack using a biological agent, such as anthrax.

Biological Threats

In 2001, she joined the Nuclear Threat Initiative, a Washington-based group focused on reducing the public safety threat from chemical, biological and nuclear weapons.

Sharfstein also is the product of a medical family. His father, Steven S. Sharfstein, is a former president of the American Psychiatric Association and a strong advocate for transparency in doctor-industry relationships. His mother, Margaret Sharfstein, is a pediatrician.

Sharfstein graduated from Harvard College in 1991 and from the university’s medical school in 1996. In 1999, he completed a combined residency program in pediatrics at Boston Children’s Hospital and Boston Medical Center. He later worked as an investigator for Representative Henry Waxman, a California Democrat who is chairman of the House Energy and Commerce Committee.

Under Waxman, Sharfstein worked on efforts to put the tobacco industry under FDA jurisdiction. Congress is now considering the Family Smoking Prevention and Tobacco Control Act, which would give the agency the power to regulate tobacco.

To contact the reporters on this story: Nicole Gaouette in Washington at ngaouette@bloomberg.net; Edwin Chen in Washington at echen32@bloomberg.net.

Last Updated: March 12, 2009 00:00 EDT