It wasn’t all that long ago that Dr. Robert Califf, the Obama administration’s nominee to head the FDA, was grilled for his close ties to the pharmaceutical industry. Yesterday, it was the turn of the Trump administration’s nominee, Dr. Scott Gottlieb, to face criticism for his links to private industry.
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.
Testifying before the Senate Health, Education, Labor & Pensions Committee yesterday, Gottlieb was bombarded by questions about potential conflicts of interest stemming from his work with NEA. The nominee for FDA commissioner has invested in or consulted for more than 24 medical device and drug companies.
Sen. Chris Murphy (D-Conn.) said Democrats have “a level of discomfort” with the nomination that stems from more than his ties to industry; Gottlieb has advised Republican presidential candidates and opposed the Affordable Care Act.
“The worry about impartiality is certainly connected to the private sector experience, but it’s also to your very deep political involvement as well,” Murphy said. “The worry here is that there will be industry-supported reforms that will find a voice inside of the agency because of your connection to the industry.”
In his opening remarks, Gottlieb pledged his impartiality; he has promised to recuse himself for 1 year from participating in FDA decisions involving more than 20 companies.
“If confirmed, I’ll lead the FDA as an impartial and passionate advocate for public health. I know what’s at stake here. People’s lives are literally on the line when it comes to the decisions FDA makes, its oversight, and its enforcement of Congress’s laws. And the American people deserve to trust that the agency is led in an impartial manner – guided only by the science that informs its work – and an abiding faith to the public health. That is the mandate by which I would lead this agency, if I were fortunate enough to win your approval,” Gottlieb said.
Republicans on the committee said Gottlieb’s experience in healthcare qualifies him to lead the agency, according to The Hill.
“As to his work with companies that have to do with drugs and food, that’s not so unusual for someone who is going to be head of the FDA, and in my view, it helps to have somebody who knows something about the subject,” chairman Sen. Lamar Alexander (R-Tenn.) said.
Sen. Rand Paul (R-Ky.) asked Gottlieb if company profits would play a factor in his decisions on safety and efficacy.
“Absolutely not, Senator,” Gottlieb said.
“I think that’s important because that goes to character, and to me, your honor is on the line when you say that and we can argue back and forth but only you can say tell us that,” Paul said, according to the website.
Mark Leahey, president & CEO of the Medical Device Manufacturers Assn., said it’s “abundantly clear” that Gottlieb is qualified to lead the FDA, saying his “passion to improve healthcare would result in a more robust ecosystem for the development of medical technology innovation.”
“If approved by the Committee and the Senate, MDMA will work closely with Dr. Gottlieb to achieve our shared mission of providing safe and effective medical technologies for patients and providers in a timely manner,” Leahy said in prepared remarks.
Material from Reuters was used in this report.