Sharfstein Leaving FDA for State Government Job

The U.S. Food and Drug Administration (FDA) is losing one of its key leaders. Deputy Commissioner Joshua Sharfstein reportedly is leaving the agency to take the top public health job in the state of Maryland.

Maryland Gov. Martin O’Malley confirmed Sharfstein’s appointment as secretary of health and mental hygiene and said he would begin his new position on Jan. 12. “Dr. Sharfstein will bring to the position the expertise and professionalism needed to continue the progress we’ve made for the people of Maryland,”O’Malley said in announcing Sharfstein’s appointment.

Sharfstein replaces John Colmers, who has led the Old Line State’s health agency since 2007. The governor credited Colmers and his own administration for expanding healthcare coverage to nearly 243,000 Maryland residents over the last three years. During Colmers’ tenure, Maryland also recorded the lowest infant mortality rate and increased access to dental care for low-income children through the Deamonte Driver project.

Sharfstein said Colmer’s accomplishments will give him a “terrific foundation” for further progress. “It is a special honor to serve my state at such a critical time for healthcare and public health,” he said in prepared remarks.

FDA officials, meanwhile, moved quickly to replace Sharfstein, if only temporarily. Authorities named John Taylor, former director of the Office of Enforcement and a counselor to FDA Commissioner Margaret Hamburg, as FDA Deputy Commissioner for the next 60 days. Officials plan to decide over the next two months whether Sharfstein’s position should be filled (and if so, how to fill it).

The FDA, however, had no official comment onSharfstein’s resignation.

David Nexon, senior executive vice president of the Advanced Medical Technology Association, called Sharfstein “a dedicated public servant who brought energy, intelligence and a commitment to public health to the FDA.”

“We wish him well in his new position and know he will make Maryland a healthier place for all its citizens,” Nexon told Medical Product Outsourcing.

A doctor and researcher, Sharfstein was public health director for Baltimore, Md., before he became the second in command at the FDA. He also had worked on Capitol Hill for U.S. Rep. Henry Waxman (D-Calif.) as an aide. He started his tenure at the FDA in March 2009 and immediately focused on investigating the December 2008 approval of the Menaflex Collagen Scaffold for repairing and reinforcing meniscal tissue in the knee. The surgical mesh, manufactured by Hackensack, N.J.-based ReGen Biologics Inc., is designed to stimulate the growth of new meniscal tissue in damaged knees.

At the end of Sharfstein’s investigation in 2009, the FDA decided to revamp the approval process for Menaflex as well as the agency’s approval standards for all medical devices. The FDA approved Menaflex under a fast-track approval process known as 510(k). Last year, FDA officials unveiled proposed changes to the 510(k) program and announced that it was revoking approval for the Menaflex Scaffold, claiming it should not have been cleared by the agency.

Sharfstein’s stint at the FDA was brief, but productive. He not only helped shape the leadership but also pushed for stronger safety standards for medical devices and better compliance by pharmaceutical firms. With both he and FDA Commissioner Dr. Margaret Hamburg at the helm, the agency has become more aggressive in regulatory matters, issuing more warning letters to companies for manufacturing and marketing violations with less negotiation time. The FDA also has begun targeting individual employees of drug companies in criminal and civil investigations, including company lawyers.

John Manthei, a partner at global law firm Latham & Watkins LLC called Sharfstein’s resignation a key loss for the FDA and said agency officials must decide on the kind of role they want his replacement to undertake. “Josh has been very active and he’s been a key player at the FDA for the last few years,” Manthei told MPO. “I think it’s going to be interesting to see the kind of role his replacement is going to play. Is the person going to continue to drive policy as Josh did, or will this person work toward implementing the policies that have been set forth by the agency over the last few years? It’s going to be interesting to see what is decided.”