Scott Gottlieb will be the new FDA commissioner.
The U.S. Senate voted 57 to 42 on Tuesday to confirm Gottlieb, a physician and venture capitalist, to lead the regulatory agency. He succeeds former FDA commissioner Robert Califf, who stepped down in January after President Donald Trump took office.
Gottlieb is already familiar with the agency he will oversee. From 2005 to 2007, he worked as the FDA’s deputy commissioner of medical and scientific affairs under President George W. Bush. After serving at the FDA, he went into the business world, becoming a venture partner at New Enterprise Associates. In his post-FDA career, he wasn’t afraid to criticize his former employer, penning op-eds critical of the agency’s speed on drug approvals and its rules on off-label drugs and generic drugs.
But some public interest groups viewed Gottlieb with skepticism. Public Citizen slammed President Trump’s nomination of Gottlieb, saying that his venture capital background creates too many conflicts of interest for someone whose job would be to regulate life science companies, including those in which he had business or investment relationships. In his confirmation hearings, Gottlieb said he would recuse himself for one year from making FDA decisions on companies in which he had a business relationship.
Gottlieb’s business ties also sparked concerns for some senators. Last month, a vote by the Senate’s Health, Education, Labor & Pensions was postponed to give senators more time to review Gottlieb’s written responses to questions about his financial ties to industry. The committee ultimately approved Gottlieb’s nomination in a vote that fell largely along party lines.
Among the names floated for nomination as FDA commissioner, Gottlieb’s emerged as the early favorite of many in the pharmaceutical industry. Trump’s pledges to slash drug prices and FDA regulations, and speed up the process of regulatory review, sparked concerns about upheaval and uncertainty at an agency that regulates products accounting for 20 percent of U.S. consumer spending. Gottlieb said during his confirmation hearings that there are opportunities to streamline the FDA, but he also emphasized that the agency needs to uphold standards of safety and efficacy.
Photo by the U.S. Senate.