Maryland Woos Away Top Deputy at the FDA

Joshua M. Sharfstein, the second-in-command at the Food and Drug Administration, is leaving that post after less than two years to become Maryland’s top public health official, Gov. Martin O’Malley said Tuesday.

The offer from O’Malley (D) came two weeks ago after John M. Colmers told the governor that he intended to step down after four years as Maryland’s secretary of health and mental hygiene, Sharfstein said.

“It was not that I was looking to leave or was burned out,” Sharfstein said in an interview Tuesday. “I was committed to the FDA. But opportunities like this don’t come along very often. It’s a really great job at a really important moment in time, and with terrific leadership in the state.

“It was impossible to turn it down.”

The new job, which Sharfstein will start next week, touches a broad array of public health issues, including infant mortality, HIV/AIDS, substance abuse, mental health and implementation of health-care reform.

The FDA had no comment on Sharfstein’s departure, according to spokeswoman Karen Riley.

Sharfstein, 41, led the FDA transition team for the Obama administration and aimed to restore the agency’s public health mission. Critics had complained that the FDA grew too cozy with the industries it regulates during the George W. Bush administration.

Once Obama tapped him to help lead the agency, Sharfstein reviewed the FDA’s approval process for medical devices and drugs. He led an investigation into the controversial approval of a knee surgery device, which resulted in the unusual finding that the FDA had incorrectly approved the device because of political pressure.

Under Sharfstein and FDA Commissioner Margaret A. Hamburg, the FDA has stepped up enforcement, cracking down on deceptive claims by foodmakers, quality problems with over-the-counter pediatric medicines, and producers of caffeinated alcoholic beverages.

Sharfstein also tried to get the agency to do a better job of explaining its actions to the public.

Diana Zuckerman, president of the National Research Center for Women & Families, said Sharfstein “inherited a dysfunctional agency, and he made substantial progress on many fronts. His efforts have saved lives, but there’s a lot more work to be done.”

A former aide to Rep. Henry A. Waxman (D-Calif.), Sharfstein frequently represented the agency on Capitol Hill and was comfortable in the witness seat.

His departure comes at a time when the FDA is under intensified congressional scrutiny, especially in the House. Rep. Darrell Issa (R-Calif.), who will chair the House government oversight committee, has called the FDA a “broken bureaucracy.”

The FDA also is taking on additional duties under an expansive new food safety law and fulfilling a recent congressional mandate to regulate tobacco.

Sharfstein said his decision to leave has nothing to do with the political environment on Capitol Hill.

“Good oversight is important to government and was not in any way a factor,” he said.

His new job will mark a return to Maryland, and to O’Malley. Sharfstein, a Harvard-educated pediatrician who lives in Baltimore, served as the city’s commissioner of health when O’Malley was mayor.

Sharfstein drew national attention in that job for his efforts to restrict the marketing of over-the-counter pediatric cold medicines.

“I’m ecstatic,” O’Malley said of Sharfstein’s return.

Sharfstein will lead a department with a $7 billion budget and a staff of more than 8,000.