The Senate on Tuesday confirmed Scott Gottlieb, President Trump’s nominee to lead the Food and Drug Administration (FDA).
Gottlieb, a former FDA director and deputy commissioner under former President George W. Bush, was confirmed in a 57-42 vote. He will replace Robert Califf, the acting FDA chief who was appointed last year by former President Barack Obama.
“As a practicing physician with a wealth of policy experience, Dr. Gottlieb has the necessary qualifications to lead the FDA at this critical time,” Senate Majority Leader Mitch McConnell (R-Ky.) said Tuesday on the Senate floor.
“Not only has he worked in hospitals, interacted directly with those affected by disease and treatment, but he also has developed and analyzed medical policies in both the public and private sectors,” McConnell added.
Democrats had raised concerns about Gottlieb’s financial ties to the industries he will be charged with regulating.
Gottlieb has invested in or consulted for dozens of healthcare companies since leaving the FDA, but committed to untangling those financial ties before taking over the agency. He signed an ethics disclosure agreeing he would recuse himself for one year from any decisions about 20 health companies he has worked with, including GlaxoSmithKline and Bristol-Myers Squibb.
Republicans, including Senate Health, Education, Labor and Pensions Committee chairman Lamar Alexander (R-Tenn.), view Gottlieb’s work with industry as an asset.
During his confirmation hearing, Gottlieb vowed to make the opioid epidemic the FDA’s top priority, calling it “the biggest crisis facing the agency.” He also wants to prioritize streamlining approvals of generic drugs in order to help bring down drug costs.
The most vocal opponent of Gottlieb’s confirmation was Sen. Edward Markey (D-Mass.), who said he fears that Gottlieb is too close to pharmaceutical companies that sell and promote opioids. In particular, Gottlieb was a paid expert witness for Cephalon when the company was sued for improperly marketing fentanyl, a powerful opioid that is now linked to hundreds of overdose deaths.
“We need FDA to be a tough cop on the beat, not a rubber stamp approving the latest big pharma painkillers,” Markey said during a floor speech Tuesday.
Moving forward, the new FDA chief will be tasked with taking a look at Obama regulations for electronic cigarettes and requirements for calorie counts on restaurant menus, as well as approvals for genetically engineered animals.
During the Obama administration, the FDA exerted its authority granted by Congress to regulate all tobacco products, including cigars and e-cigarettes, but it is unclear if Gottlieb will bend to industry pressure and roll back the regulations.
Sen. Sherrod Brown (D-Ohio) raised concerns about investments Gottlieb has made in the e-cigarette industry.
“His job is to police big tobacco, to stand between these multi-million dollar marketing executives and the 15-year-olds who are attracted to these products,” Brown said Tuesday on the Senate floor. “And he’s invested in these companies in the past. So can we really trust him?”
Sen. Maggie Hassan (D-N.H.) also raised “serious concerns” about Gottlieb’s views on women’s health issues.
Gottlieb has a “record of putting politics ahead of science when it comes to women’s health,” Hassan said Tuesday on the floor.
“I’m concerned under his leadership the FDA will play political games with women’s health once again,” she said.
Lydia Wheeler contributed.