Scott Gottlieb, President Donald Trump's pick to lead the FDA, told lawmakers April 5 that his "unique" experience working as a venture capitalist, industry consultant and a medical product company board member made him the perfect candidate to take the agency's helm.
But he also said those industry ties and his outspokenness on political matters would not prevent him from upholding the FDA's "gold standard" of ensuring that drugs, vaccines and medical devices are safe and effective before the agency allows them to enter the U.S. market.
Gottlieb, a physician and a former FDA deputy commissioner whom Trump nominated March 10, is a partner specializing in healthcare investments at New Enterprise Associates — one of the world's largest and most active venture capital firms — and is a managing director of investment banking at T.R. Winston & Co.
He has served on several biopharmaceutical company boards and is a member of GlaxoSmithKline PLC's product advisory board.
But Gottlieb said that if he was confirmed as FDA commissioner — a job for which many in industry have said he is perfectly suited and is expected to easily win — he would resign from those positions and recuse himself for one year from decisions involving companies in which he was invested. He also plans to divest his interests in the companies.
Sen. Patty Murray, D-Wash., ranking member on the Senate Health, Education, Labor and Pensions Committee, however, raised concerns about Gottlieb's "unprecedented financial entanglements" with the industries he would regulate as FDA commissioner and said she struggled with how he would ensure that his views would not be shaped by his investments.
Murray noted the companies Gottlieb invested in have more than 60 drugs that could come before the FDA for evaluation, and the businesses he has worked for have interests in more than 120 medicines currently in clinical testing.
"I recognize the importance of bringing impartiality to this position," Gottlieb told the committee. "I recognize that someone could look at my background and have these questions.
"I am going to be cognizant of trying to make sure I preserve the integrity of my role and do nothing in exercising my obligations, if I'm confirmed into this role, that would besmirch the agency and reduce people's confidence in the agency's mission."
"This is exceedingly important to me," Gottlieb said. "I get it. I know why people care. The FDA's decisions are literally matters of life and death, and I don't want to do anything in my conduct to reduce people's confidence in the agency's mission."
But as someone who has moved in the regulatory and industry worlds, Gottlieb said he was "uniquely suited," because he understands the FDA's mission of protecting and promoting public health, while also knowing "how companies have tried to game the process."
"What I want is a framework in place that prevents those kinds of things from happening so people can't use the regulatory process as a commercial arbitrage to gain unfair advantages," Gottlieb said.
"I think that's where my work does inform some of these issues," he said.
Gottlieb said he was eager to "earn and keep the public's trust."
Opioids crisis needs Ebola-like attention
Several members on the Senate HELP Committee quizzed Gottlieb on how he would address some of the FDA's most pressing issues, particularly the role the agency plays in the opioids epidemic plaguing the U.S.
"This is a public health emergency in the order of Ebola and Zika, and I think we need to treat it that way," Gottlieb said. "It's a public health crisis that's going to require dramatic action."
He pledged to make the job of tackling the crisis his "highest and most immediate priority."
Science vs. politics
Democrat Sen. Chris Murphy, who introduced Gottlieb at the hearing, noting he is one of his Connecticut constituents, also said he was concerned about whether the FDA candidate could keep his "deep" political views, which includes public opposition to the Affordable Care Act, out of his work.
The lawmaker also said he was worried Gottlieb would be pressured by Trump not to follow science-based evidence.
"You are going to be working for a president who has been a frequent critic of vaccinations and also suggested he may convene a political commission looking into the connection of vaccines and autism," Murphy said.
But Gottlieb said that after "one of the most exhaustively studied questions in scientific history," he agreed with the conclusion from the National Academy of Medicine and other "esteemed" bodies that "there is no link."
"At some point we have to accept no for the answer," he said.
Gottlieb said he would not be shy about expressing his "unvarnished" opinion and scientific advice, including to his bosses, and would keep politics out of FDA decisions.