A Medical Device Daily

Scott Gottlieb, MD, deputy commissioner for medical and scientific affairs at the FDA, this week said that he will leave the agency in mid-January to return to the American Enterprise Institute (Washington), a “think tank” where he was previously a resident fellow.

Gottlieb joined the FDA in July 2005 and since that time has worked on a number of significant policy initiatives, including efforts to improve the advisory committee process and to make the agency’s approaches regarding communication of risk information to the public more effective.

Gottlieb also helped to implement new regulations and policies, including the new drug and biologic products labeling rule and the expanded access rules to help patients with life-threatening conditions gain access to drugs under development. An internist, Gottlieb continued to practice medicine during his tenure as a public health official.

“Throughout Scott’s tenure at both FDA and the Centers for Medicare and Medicaid Services, he has served the public health with tireless dedication,” said Andrew von Eschenbach, soon to be formal head of the agency. “Scott joined the agency at a critical time and helped to create a forward-thinking policy agenda that bolstered our efforts to transparently provide more timely information to patients and providers so they can have the tools they need to make informed medical decisions.”