Current Position: Food and Drug Administration Principal Deputy Commissioner (since March 2009)
Why He Matters
Sharfstein, who made a name for himself as commissioner of the Baltimore Health Department, is Barack Obama's choice to be principal deputy commissioner of the Food and Drug Adminstration (FDA), after leading the transition team that assessed the beleaguered agency.
A pediatrician with an interest in public health, Sharfstein grabbed headlines in 2007 when he spurred an investigation into the safety and effectiveness of cough-and-cold medicine for young children. The investigation sparked a national discussion, and the pharmaceutical industry pulled many of those medicines from the shelves. The FDA is looking into creating new rules on the matter.
The FDA has been bogged down by criticism on issues from its drug-approval process and handling of tainted medicine and food from China. Sharfstein may be just the right type of outside crusader to help radically overhaul the troubled agency.
Sharfstein works under FDA Commissioner Margaret A. Hamburg, a bioterrorism expert. Some reports say Sharfstein was considered for the top job, but pharmaceutical lobbyists feared he would be too tough on drug approvals and pledged to block his confirmation. As deputy, Sharfstein was not subject to Senate confirmation.
Sharfstein's appointment could be a sign that the Obama administration hopes to split the FDA into two parts, with Hamburg focusing on food safety, and Sharfstein running drug approvals.
At a Glance
Current Position: Food and Drug Administration Principal Deputy Commissioner (since March 2009);
Career History: Baltimore Health Commissioner (2005 to 2009); Investigator and health policy adviser, House Government Reform and Oversight committee (2001-2005)
Birthday: N/A
Hometown: Montgomery County, Md.
Alma Mater: Harvard College, B.A. 1991; Harvard Medical School M.D. 1996
Spouse: N/A
Religion: N/A
Office: 1001 E. Fayette Street, Baltimore, Maryland 21202
Email
Web site
Path to Power
Sharfstein grew up in Montgomery County, Md., where his father was a respected psychiatrist. He spent summers in Baltimore with his grandparents.
Sharfstein attended Harvard University and was editorial chair of the Harvard Crimson newspaper. He wrote opinion pieces on everything from why conservatives were wrong on abortion to his own Twilight Zone-esque experiences interviewing at medical schools. He graduated with a bachelor’s degree in 1991. He went on to Harvard Medical School, graduating in 1996.
While in medical school, Sharfstein read a New York Times article about George H.W. Bush’s policy forbidding abortion counseling in federally-funded clinics. “The AMA [American Medical Association] always seemed to support the candidates I was fighting against,” Sharfstein said. He researched the subject, and he and his psychiatrist father, Steven S. Sharfstein, wrote an article analyzing the American Medical Association’s campaign contributions. They concluded that when [the AMA] gave money they didn’t care about the person’s public health position,” Sharfstein said. The article was published in the New England Journal of Medicine in 1994.
In 1997, the younger Dr. Sharfstein appeared in the New England Journal of Medicine once again, this time protesting a Pfizer marketing event that offered doctors free alcohol and billiards games. “Attending such an event is unethical, according to the guidelines of the American Medical Association’s council on ethical and judicial affairs,” he wrote.
Pfizer responded to the Journal, saying it had shown three informative slide presentations to the doctors, but admitted the event "created a poor impression."
After medical school, Sharfstein stayed in Boston to do a residency in pediatrics at Boston Children’s Hospital and Boston Medical Center, which he finished in 1999. He completed a fellowship in general academic pediatrics at Boston University in 2001. He made headlines again while still a 28-year-old pediatric fellow when he co-authored a 2001 report calling poor housing conditions a health risk for children.
Capitol Hill Aide
After his fellowship, Sharfstein went to Washington, D.C., where from 2001 until the end of 2005 he was an investigator and health-policy adviser on the House Government Reform and Oversight committee, led by Rep. Waxman. He worked on projects related to scientific integrity, HIV/AIDS, FDA oversight, public health preparedness and other health topics, according to his official biography. He also worked toward giving the FDA authority to regulate the tobacco industry, a favorite Waxman cause. “A bill along those lines seems poised for passage next session,” the Wall Street Journal reported in December 2008.
Sharfstein helped pass a bill classifying colored contact lenses as “medical devices” instead of “cosmetics.” The bill reversed an FDA decision after a number of people went blind because of wearing the lenses.
In 2005, Baltimore Mayor Martin O’Malley (D) appointed Sharfstein the city’s commissioner of health. He was reappointed in 2008 by Mayor Sheila Dixon (D).
During his headline-making tenure as health commissioner, Sharfstein famously limited the sales of over-the-counter cough-and-cold medicines to small children. His 2007 investigation into the drugs’ safety garnered national media attention.
Sharfstein was a health policy adviser to the 2008 Obama campaign and was asked to be a part of the transition team, investigating policies at the Health and Human Services Department. He focused on the FDA.
Sharfstein lives in Baltimore with his wife and two children. He is a fan of the NPR show Wait, Wait, Don’t Tell Me. “One of my life's ambitions is to be a contestant on the show," he told the Baltimore Sun.
The Issues
The troubled FDA is under Congressional investigation for a variety of issues, including its approval of lucrative drugs that were later recalled, and its handling of contaminated products from China, including milk products and the blood-thinning drug Heparin.
"The principal challenge for the agency is to reestablish its credibility," Sharfstein said while heading the FDA review for the Obama transition team. "When the agency loses credibility, you have a crisis that affects people and undermines confidence in the overall regulatory system, and that's not good for anybody."
Sharfstein works with FDA Commissioner Margaret A. Hamburg to try to reinstill confidence in the agency, which could mean a major overhaul.
Peter J. Pitts, a former FDA associate commissioner who is president of the Center for Medicine in the Public Interest, told the New York Times that the selections of Hamburg and Sharfstein could be a sign that the Obama administration wants to split the FDA into two parts.
“I think Dr. Hamburg will become the commissioner of food, since she’s a safety and security person,” Mr. Pitts told the Times, “and then Dr. Sharfstein would slide into the F.D.A., which would become the Federal Drug Administration.”
Reviewing FDA Approvals
Under Hamburg and Sharfstein, the FDA asked the Institute of Medicine to review their approval process for medical devices, an unprecented move.
In September 2009, Sharfstein announced that the approval of a medical device from the New Jersey company ReGen was improperly influenced by four New Jersey lawmakers and by the previous FDA director Andrew C. von Eschenbach. All four New Jersey lawmakers, Sens. Robert Menendez (D) and Frank R. Lautenberg (D) and Reps. Frank Pallone, Jr., (D) and Steven R. Rothman (D), had received large campaign contributions from ReGen within months of pushing for the device's approval.
“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Sharfstein told reporters. He said the FDA would review the device anew.
"The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct," The New York Times reported at the time.
Tobacco Regulation
Early in the Obama administration, the Senate approved a bill giving the FDA oversight of tobacco products, including the power to regulate how much addictive nicotine is added to cigarettes.
In one of the first moves to regulate tobacco, the FDA banned chocolate-, vanilla- and clove-flavored cigarettes that are believed to encourage children to take up smoking.
In November 2009 the FDA asked the makers of caffeinated alcoholic drinks, which are popular among college students, to prove that the drinks were safe.
Childhood Vaccines
Though Sharfstein has a reputation as a drug-industry watchdog, he is a strong supporter of childhood vaccinations. Critics say childhood immunizations could be linked to autism, but no medical studies have supported that theory. Sharfstein has called vaccination crucial to the public health. He testified against a 2008 bill in the Maryland legislature that would have cut children’s flu vaccinations by 75 percent, the Wall Street Journal reported.
Children’s Cough-and-Cold Medicine
Sharfstein came onto the national scene with a 2007 investigation into the safety of over-the-counter cold medicines for young children, which caused major companies to pull drugs from the shelves. Cold medicine had been linked to the deaths of four Baltimore children, and Sharfstein knew there was no medical evidence that cough and cold medicines helped children six years of age and younger.
"This has been on my radar since medical school," Sharfstein told Governing Magazine. "Because what we were taught in school and what pediatricians were practicing in the field was so different."
He launched an investigation into cough-and-cold medicine safety for children that provoked concern in parents all over the country. As a result, the pharmaceutical industry voluntarily removed medicines marketed as safe for children under the age of two from stores.
Sharfstein and a group of Baltimore pediatricians petitioned the FDA for new warning labels on non-prescription childrens’ drugs including nasal decongestants, antihistamines and combination cough-and-cold products. This summer, the FDA announced that it would look into creating rules for the drugs. Sharfstein also published a 2007 New England Journal of Medicine article on the risks of over-the-counter cough and cold medicines in young children.
As Baltimore commissioner, Sharfstein also sought to eliminate lead in childrens’ jewelry.
The Network
The Wall Street Journal said Sharfstein has “a powerful patron in Rep. Henry Waxman.” Sharfstein was a staffer for Waxman (D-Cal.) when the Congressman was running the House Government Reform and Oversight Committee. In November 2008, Waxman ousted Rep. John Dingell (D-Mich.) to become chairman of the House Energy and Commerce Committee.
Waxman’s longtime chief of staff, Phil Schiliro, will be Obama's chief of legislative affairs.
Sharfstein’s father, Steven S. Sharfstein, runs Sheppard Pratt, which is the largest system of psychiatric hospitals in Maryland, and lectures at Johns Hopkins University. He was president of the American Psychiatric Association from 2005 to 2006. The elder Dr. Sharfstein has long been interested in the intersection of psychiatry and public health. During the Carter administration, he worked closely with Rosalynn Carter on the Mental Health Systems Act of 1979. In addition to a medical degree, Steven Sharfstein has a master’s degree in public administration from the Kennedy School of Government at Harvard University.
Campaign Contributions
Sharfstein has not made any political contributions according to the Center for Responsive Politics. His father, Steven, has long supported Democratic candidates and gave $2,300 to
Hillary Rodham Clinton early in her 2008 presidential campaign.
