Senate approves Gottlieb as FDA chief

The U.S. Senate voted 57-42 yesterday to confirm Dr. Scott Gottlieb as commissioner of the FDA.

Gottlieb, 44, is a former FDA deputy commissioner who has advocated a loosening of requirements needed for approval of new medical products. He is also a resident fellow at the conservative American Enterprise Institute think tank, a partner at venture capital firm New Enterprise Assoc., and sits on the boards of multiple healthcare companies. The Senate Health, Education, Labor & Pensions Committee approved Gottlieb on a 14-9 vote last month.

Democrats who opposed the nomination criticized Gottlieb for being too cozy with the medical device and drug industries.

“It is inappropriate for the FDA commissioner to have had such close financial ties with the pharmaceutical industry,” Sen. Joe Manchin  (D-W.Va.) said in prepared remarks.

Mark Leahey, president & CEO of the Medical Device Manufacturers Assn., said the group “looks forward to working with [Gottlieb] to achieve our common goals of improving patient care and spurring medical technology innovation.”

“While the regulatory environment has improved over the years, we know that there is more work to do to establish reasonable and predictable pathways for the next generation of medical devices. Patients and providers continue to search for solutions to the pressing needs facing the health care system, and med tech innovators are working to develop the cures and therapies that they desperately need,” Leahey said in a prepared statement. “MDMA and our members are committed to working closely with Dr. Gottlieb to ensure that the United States remains the global leader in medical technology innovation, and that our industry can build upon our proud track record of alleviating human suffering and saving lives.”

AdvaMed president & CEO Scott Whitaker said Gottlieb’s experience at the FDA and the Centers for Medicare & Medicaid Services “make him uniquely qualified to lead this vital agency.”

“Dr. Gottlieb recognizes the crucial role of medical technology in solving some of our nation’s most daunting health care challenges and the importance of a strong, efficient and predictable FDA in ensuring continued patient access to safe and effective medical innovations,” Whitaker said. “We look forward to working with Commissioner Gottlieb and his team on efforts to improve the FDA review process as well as reauthorization of the Medical Device User Fee Act and implementation of the 21st Century Cures Act.”