Sharfstein to leave spot at FDA

FDA Deputy Commissioner Joshua Sharfstein is leaving the agency and taking the top public-health job for the state of Maryland. Maryland Gov. Martin O'Malley intends to make the official announcement of the new head of Department of Health and Mental Hygiene today, the Baltimore Sun notes, citing a spokesman for the governor.

O'Malley offered the job to him two weeks ago after John Colmers said 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, as quoted by the Washington Post. "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."

When Sharfstein's name was announced as Obama's choice for deputy commissioner, industry insiders were reportedly nervous. He once served as an investigator for Henry Waxman, serving as the go-to guy on many public health issues, including off-label drug marketing and pharma gifts to physicians. And as Baltimore Health Commissioner, he pressed the FDA to re-evaluate the safety of cough and cold meds for kids.

Sharfstein's planned departure was first reported by CQ HealthBeat, which reminds readers that Sharfstein led the Obama transition team that remolded the FDA. The agency had drawn criticism during the George W. Bush administration for being too close to industry, CQ adds. Indeed, the Journal notes that since his arrival in late March 2009, when he was briefly acting commissioner, Sharfstein has shaken up several divisions of the agency, notably drugs and medical devices, pushing for stronger safety standards and better compliance.

As Mass Device points out, Sharfstein helmed a probe into the watchdog's controversial 2008 clearance of ReGen Biologics' Menaflex knee implant. That probe led to the agency's decision to put the device through its paces again, which in turn prompted the rescission of the clearance.

As Maryland's health secretary, Sharfstein will oversee a $9 billion budget which includes the Medicaid program, the Baltimore Sun reports. The new secretary will work to implement the Obama healthcare overhaul, an issue that O'Malley is prioritizing, the paper adds.

- see the Washington Post story
- check out the report from Mass Device
- get more from the WSJ
see the Baltimore Sun story
- check out the CQ Healthbeat report