Gottlieb leaving FDA to rejoin think tank

Scott Gottlieb, deputy commissioner for medical and scientific affairs at FDA, is leaving the agency to rejoin the American Enterprise Institute on January 16. Commissioner Andrew von Eschenbach praised Gottlieb for “serving the public health with tireless dedication,” noting his instrumental role in advancing the agency’s critical path initiative and improving risk communications to patients and providers. Gottlieb was briefly a resident fellow at the center-right Washington think tank before rejoining the FDA in July 2005. He had previously served at the agency as senior adviser to the administrator for medical technology, from 2003-2004, and as director of medical policy development in 2004. He also worked at the Center for Medicare and Medicaid Services as senior adviser to the administrator in 2004. Gottlieb frequently served as the voice of the agency on policy issues in the absence of a permanent commissioner, most recently outlining the agency’s drug safety initiatives, calling for increased PDUFA fees for pharmaceutical companies and questioning the prosecutions of companies for distribution of information on off-label drug uses. He helped develop the new drug and biologic products labeling rule and expanded access rules to help patients with life-threatening conditions gain access to developmental drugs. He is also renown for his understanding of the healthcare industry, honed as a past author of the Forbes/Gottlieb Medical Technology Investor newsletter, the Gilder Biotech Report and as a healthcare analyst for Alex Brown & Sons.