Scott Gottlieb’s nomination to the top post of the FDA is on its way to the full U.S. Senate.
The Senate Health, Education, Labor & Pensions Committee voted 14-9 on Thursday to approve Gottlieb’s nomination to become FDA commissioner. All of the Republicans on the committee voted for Gottlieb, along with two Democrats, Sen. Sheldon Whitehouse of Rhode Island and Sen. Michael Bennet of Colorado.
The vote was originally scheduled for Wednesday morning. But Sen. Lamar Alexander, a Republican from Tennessee and chairman of the committee, postponed the vote one day, citing scheduling issues. Sen. Patty Murray of Washington, the committee’s ranking Democrat, said that Gottlieb’s written responses to financial questions were received just 45 minutes prior to the committee’s Wednesday meeting and the members needed more time to review them. Those responses were not made public, but Gottlieb’s answers apparently did not persuade Murray to vote yes.
Gottlieb would bring to the FDA a resume that includes a mix of clinical, regulatory, and business perspectives. A physician by training, he has also worked at the FDA. During George W. Bush’s presidency, Gottlieb served at the FDA as deputy commissioner of medical and scientific affairs, between 2005 and 2007. He later went on to become a venture partner at New Enterprise Associates.
At the outset of his administration, President Trump said he wanted to slash FDA regulations and speed up the process for approving new drugs and medical devices. He also signaled openness to nominating an outsider for the regulator’s top spot, a post traditionally held by a physician. Gottlieb’s name emerged in the mix of potential candidates, among several individuals whose backgrounds included both clinical and investing experience.
Many pharmaceutical executives, who feared that someone unfamiliar with the life sciences industry could impose radical changes, favored Gottlieb for the FDA post. Before Thursday’s vote, Alexander noted that Gottlieb’s nomination had the support of former FDA commissioners Robert Califf, Margaret Hamburg, and Scott McClellan.
Gottlieb hasn’t been afraid to speak out about his former (and prospective) employer. He has penned several op-eds criticizing the slowness of FDA drug approvals and its rules governing generic drugs, among other pharma issues. In a three-hour committee hearing earlier this month to consider his nomination, Gottlieb spoke about streamlining FDA regulations. But he also emphasized that the FDA must uphold standards of safety and efficacy for the products it regulates.
Scott Gottlieb photo by the U.S. Senate.