Scott Gottlieb, a former deputy commissioner of the U.S. Food and Drug Administration, is President Donald Trump’s choice to lead the agency, according to an emailed statement from the White House.
Gottlieb, 44, served in several senior positions at the FDA during the George W. Bush administration. He has talked extensively about how to lower the cost of prescription drugs by modernizing the agency’s approval process and speeding cheaper generic competitors to market.
Since leaving the FDA, Gottlieb has worked as an adviser to investment firms and as a fellow at the conservative-leaning American Enterprise Institute, a Washington think tank. He has been the drug industry’s preferred choice for the FDA job and has worked as a consultant to some of its companies.
Gottlieb must be confirmed by the Senate before he takes over at the agency.
Gottlieb is a more mainstream nominee than some of the other candidates who were said to be under consideration. He’s a partner at one of the world’s largest venture capital firms, New Enterprise Associates, which has a portfolio of more than 300 businesses in the technology and health-care industries, according to its website.
Other names for the FDA post that Trump considered in the past, according to people familiar, were Jim O’Neill, a Silicon Valley investor who has suggested that drugs need to be assessed only for safety, not efficacy, before they’re approved. Another was biotech executive Balaji Srinivasan, who’s tweeted that the FDA “bears responsibility for many deaths” because it “blocked many good drugs.”
While Gottlieb has focused on easing regulations, he “understands the agency and has some respect for it,” Diana Zuckerman, president of the National Center for Health Research, said in an interview before the news that Gottlieb is the leading candidate. The center is a Washington think tank that promotes education and research on policies that benefit patients.
Consulting, Speaking Fees
The government watchdog group Public Citizen called Gottlieb’s deregulatory approach “dangerous.” He received at least $413,000 in consulting and speaking fees from medical-product companies in 2013 to 2015, Public Citizen said. Those payments came from drugmakers including GlaxoSmithKline Plc, Valeant Pharmaceuticals International Inc. and Vertex Pharmaceuticals Inc., according to the U.S. government database that tracks physician payments from drugmakers.
“Gottlieb’s appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients,” Public Citizen said in a statement.
Most of Trump’s public comments about the drug industry have focused on prices. On Tuesday, Trump tweeted that he’s working on a “new system” that will bring costs “way down.”
In past speeches, Gottlieb has indicated a link between lowering prices and speeding approval. He’s praised the FDA cancer division’s efforts in getting drugs approved faster, and suggested that other parts of the agency need to emulate its approach, particularly for rare genetic diseases.
Making drug testing more efficient could ultimately “lower the costs that need to be recouped after a drug is approved,” he said at a May 2016 conference in Washington.
In a March 6 speech at a conference in Orlando, Florida, Gottlieb also talked about overhauling the rules for complex generic drugs with which brand-name companies have been able to create “monopolies in perpetuity.” He also discussed the need to inject competition in situations where decades-old drugs are provided by one generic supplier, allowing speculators to buy the drug and jack up the price.
If the FDA can accelerate approval for older generics, “the market will basically have a self-correcting mechanism for those distorted prices on old generics,” said Alex Azar, a former Eli Lilly & Co. executive and health official under President George W. Bush, in an interview last week before Gottlieb emerged as the front-runner.
Gottlieb was trained as a physician and completed his residency in internal medicine at Mount Sinai Medical Center in New York after graduating from the Mount Sinai School of Medicine in 1999. He earned a degree in economics from Wesleyan University in 1994.
“Throughout his career, including his time at the agency, Scott has shown that he has the skills necessary to continue to lead the FDA to be patient-centered and science-focused,” said Ellen Sigal, founder and chair of Friends of Cancer Research. The group works with patients and regulators to try to accelerate the approval of promising drugs.
In his past stint at FDA, Gottlieb served as deputy commissioner for medical and scientific affairs and helped coordinate with the White House and the Department of Health and Human Services. Part of his work included facilitating talks that led to a system in which generic drug manufacturers pay a fee to help accelerate the review of their products, similar to one in place for brand-name drugs.
Gottlieb also worked at the Centers for Medicare and Medicaid Services, where he helped implement the Medicare Part D program that provided prescription drug coverage for seniors.