Sharfstein is favorite son for FDA post

Dr. Joshua M. Sharfstein, Baltimore's outspoken health commissioner, is regarded by many as a leading candidate to head the Food and Drug Administration.

Sharfstein is a former congressional staffer who carved out a national profile by convincing drug companies to stop marketing cough and cold medicines to young children. The 39-year-old pediatrician has been spending two days a week in Washington lately as one of a handful of people reviewing health policies for President-elect Barack Obama's transition team. And he is being pushed for the FDA commissioner's position by members of Maryland's congressional delegation.


"He's a young, bright guy who is just the type of person Senator Obama surrounds himself with," said Sen. Benjamin L. Cardin. He said Sharfstein would restore "the traditional functions" of the FDA "in protecting the public and being aggressive and looking at new ways to do that."

Cardin and Sen. Barbara A. Mikulski have both communicated their support of the Harvard-educated physician to the transition team, and Rep. Elijah E. Cummings says he plans to. All three are Democrats.


Sharfstein came to Baltimore in 2005 after four years as a health policy adviser to Rep. Henry A. Waxman. Waxman, a California Democrat with close ties to the incoming Obama administration, will take over the House committee that oversees the FDA in January.

Sharfstein wouldn't comment yesterday on the speculation. "I love my job and I'm looking forward to another year of public health progress in the city," he said.

Sources close to the situation say no decision is imminent. Former Sen. Tom Daschle was named last week as Obama's choice to be secretary of the Department of Health and Human Services. The FDA is part of his department.

"He comes with his own reputation within the Obama team," Cardin said. "It's not like he's an unknown quantity. And he has other support on Capitol Hill. He has significant contacts to the Obama administration. What I don't know is who the competition is and what the team is looking for."

On blogs and in the press, Sharfstein is routinely mentioned on a short list of likely contenders for FDA commissioner. According to the Wall Street Journal, others being talked about are Cleveland Clinic cardiologist Steve Nissen, Duke University's Robert Califf, food and drug lawyer Frank Sasinowski and Janet Woodcock, head of FDA's drug center.

William K. Hubbard, a former associate commissioner at the FDA, said that he has heard all of the buzz but that it's way too early to take any of it seriously. In his experience, the head of the FDA typically isn't named until spring at the earliest, after deputy commissioners and general counsel jobs are filled inside HHS.

It is possible the appointment could happen more quickly this time, since the FDA and its troubles have been in the news over the past year. Problems have ranged from contaminated heparin doses from China to melamine in imported pet food to a salmonella outbreak that took weeks to contain.

Still, Hubbard said, someone like Sharfstein - a doctor with experience in policymaking and management - could appeal to the new administration.


"He fits a lot of the key criteria," Hubbard said. "He's a physician. He's a Democrat. He worked for a key Democrat in Congress. He's not a Clinton re-tread. He's a new face. He represents change."

Sharfstein, who grew up in Montgomery County, is the son of two doctors and is married to another one, Yngvild Olsen, medical director of the Harford County Health Department. They have two sons, ages 6 and 8.

Sharfstein has tackled health policy since his medical training. He was 24 when a paper on American Medical Association political contributions - co-written with his father - was published by the New England Journal of Medicine. Seven more peer-reviewed articles followed.

He volunteered at the FDA, writing and editing portions of the agency's legal argument to regulate tobacco as an addictive drug. In Waxman's office, Sharfstein worked on various pieces of legislation related to the FDA, including one that forced the agency to regulate nonprescription colored contact lenses not as cosmetics but as medical devices.

As Baltimore's health commissioner, Sharfstein has gone after the hazard of lead, banning its use in eyeliner and in candy and jewelry sold in the city. He also took on the makers of cough and cold medicines, convincing the FDA that there was little proof that the drugs worked in children under the age of 4 and evidence that they could cause harm.

He is also a backer of the use of buprenorphine as a treatment for heroin addicts, and the city Health Department says heroin overdoses are down. But critics say addicts using what is known as "bupe" may be no better off than those using methadone.


Cummings, who was one of Obama's early supporters in Congress, said Sharfstein would "be ideal" in the post - except that the city would lose an important leader in public health.

"I'm telling you, I have the highest confidence in this guy," Cummings said. "And I'm not saying it lightly. I think it's because he really cares. He truly cares. He synchronizes his conduct with his conscience."

In a statement, Baltimore Mayor Sheila Dixon said she is proud that Sharfstein is working with Obama but hopes it won't be permanent.

"He understands that there is more work to be done to make Baltimore a healthier and safer city, and I want him to be a part of our plans as we move the city forward," she said.

Finding the right person to run the FDA can be a "balancing act," said Les Funtleyder, a health care strategist for Miller Tabak + Co. in New York. Those in the pharmaceutical and bio-tech companies are looking for one thing, consumer groups another.

"I think that is a tough job, maybe I'll say thankless job," said Funtleyder, whose book, Healthcare Investing: Profiting from the New World of Pharma, Biotech, and Health Care Services, is set to be published in January.


"Everyone's against you. If you're too slow, industry and analysts get mad at you. If you're too fast and something slips through the cracks [with regard] to safety ... you end up being investigated by Congress."

Baltimore Sun reporter Annie Linskey contributed to this article.


Age: 39


Baltimore health commissioner, 2005 to present


Health policy adviser to Rep. Henry A. Waxman, 2001-2005


B.A., Harvard College, 1991.

M.D., Harvard Medical School, 1996.

Combined residency in pediatrics, Children's Hospital Boston and Boston Medical Center, 1996-1999.

Fellowship, Boston University School of Medicine, 1999-2001.