Scott Gottlieb (born June 11, 1972) is an American physician and investor who served as the 23rd commissioner of the Food and Drug Administration (FDA) from 2017-2019. As of June 2026, he is a senior fellow at the conservative think tank the American Enterprise Institute (AEI); a partner at the venture capital firm New Enterprise Associates (NEA); and a member of the board of directors of the pharmaceutical company Pfizer, Inc, the health insurance company UnitedHealth Group, and the gene sequencing company Illumina, Inc. Gottlieb is a contributor to cable financial news network CNBC and the CBS News program Face the Nation. An elected member of the National Academy of Medicine, he is the author of The New York Times best selling book Uncontrolled Spread on the COVID-19 pandemic and the national security vulnerabilities that it revealed.
Before becoming FDA Commissioner, he was a Clinical Assistant Professor at New York University Grossman School of Medicine, the FDA's Deputy Commissioner for Medical and Scientific Affairs, a venture partner with New Enterprise Associates (NEA) from 2007 to 2017, a member of the policy board of the Leukemia & Lymphoma Society, a senior official at the Centers for Medicare & Medicaid Services, and a member of the Federal Health Information Technology Policy Committee, which advises the United States Department of Health and Human Services on healthcare information technology.
Early life and education Gottlieb grew up in East Brunswick, New Jersey, the son of Stanley, who was a psychiatrist, and Marsha Gottlieb, who was a schoolteacher. His family is Jewish. He is a graduate of East Brunswick High School and received his bachelor's degree in economics from Wesleyan University. After completing his undergraduate education, he worked as a healthcare analyst at the investment bank Alex. Brown & Sons in Baltimore. Gottlieb attended medical school at Icahn School of Medicine at Mount Sinai and completed his residency in internal medicine at the Mount Sinai Hospital. ].
Career
FDA and CMS (2003–2007) Gottlieb worked for the U.S. Food and Drug Administration (FDA) from 2002 to 2003 and 2005 to 2007. He first served as a senior advisor to the FDA Commissioner and then as the FDA's Director of Medical Policy Development from 2002 to 2003. He helped initiate the FDA's generic drug user fee program and the Physician Labeling Rule. He worked on development of the FDA's policies related to the tentative approval of fixed-dose combination drugs for the treatment of HIV/AIDS under the PEPFAR program. He left the FDA in the spring of 2003 to become a senior advisor to the Administrator of the Centers for Medicare & Medicaid Services (CMS), where he worked on implementation of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), with its new Part D drug benefit, and helped advance the agency's coverage policies related to new medical technology.
He returned to the FDA from 2005 to 2007 as the agency's Deputy Commissioner for Medical and Scientific Affairs, where he was appointed to the Senior Executive Service and granted a top secret security clearance. He was a member of the Biodefense Interagency Working Group to help draft a strategic plan for U.S. biodefense countermeasures. He also worked on advancing a framework for the creation of a generic drug user fee program, final implementation of the physician labelling and pregnancy labelling rules, and pandemic preparedness. In that latter role, Gottlieb recused himself from parts of the planning effort on a bird flu vaccine in 2005, because he had done consulting work for GSK, whose products might be used.
Private sector (2007–2017) Gottlieb practiced internal medicine as an attending physician at New York University's Tisch Hospital in New York City. In 2007, Gottlieb became a venture partner at New Enterprise Associates (NEA), the world's largest venture capital firm by assets under management. Gottlieb served as an active investing partner in the firm's healthcare division. He served on the boards of directors of several NEA portfolio companies, including Bravo Health (a Medicare Advantage health plan) and American Pathology Partners (a specialized anatomical pathology service provider). Gottlieb remained at NEA from 2007 until his appointment to be FDA Commissioner in May 2017.
Prior to becoming FDA Commissioner, Gottlieb testified about 20 times before committees of the United States House of Representatives and the United States Senate on issues related to FDA regulation and drug competition,Gottlieb, Scott, "EpiPen Price Increases: How Regulatory Barriers Inhibit Pharmaceutical Competition", Statement before the Senate Committee on Health, Education Labor and Pensions: Subcommittee on Children and Families via AEI, October 7, 2016. drug shortages, Medicare reimbursement and healthcare reformGottlieb, Scott, MD, "Health Care Solutions: Increasing Patient Choice and Plan Innovation", Testimony before the United States House Committee on Energy and Commerce Subcommittee on Health via AEI, May 11, 2016. and medical innovation.Gottlieb, Scott, "Restoring the Trust for All Generations: Americans at or Near Retirement", Statement before the House Committee on the Budget via AEI, July 13, 2016. During congressional investigations of the rise of the price of EpiPen, Gottlieb presented testimony arguing that the generic drug industry is burdened by regulation that slows the development and review of new generic drug applications. These regulations, he argued, made it especially hard to bring forward generic equivalents of complex drugs, including hard-to-formulate medicines and drugs coupled to a device delivery system—a category of medicines that includes EpiPen. He argued that such excessive regulations "undermine the competitive opportunities that could help inspire more choice and competition, and help lower costs."
Gottlieb was an independent director at Tolero Pharmaceuticals and Daiichi Sankyo Inc. and a member of GlaxoSmithKline's product investment board, which made decisions on which drugs GSK would take forward in development. He was a senior healthcare advisor to BDO and also a partner at a merchant bank with a focus on healthcare."Scott Gottlieb {first-person bio}", forbes.com. Retrieved March 10, 2017. In 2015, he served on the board one of the investment firm's portfolio companies that was a provider of vaping products, Kure Corp. During this time, Gottlieb was a regular contributor to the Wall Street Journal editorial page and published a regular feature in Forbes related to healthcare and medical innovation, and he served on the editorial board of the Food and Drug Law Institute's publication entitled Food and Drug Policy Forum that "provides for the exchange of ideas and recommendations on state, national, and international food and drug law and policy issues" and serves as a forum for discussion of regulatory policy in the food, drug, and medical device industry.
FDA commissioner (2017–2019)
Starting in summer 2016, Gottlieb worked as an advisor to Donald Trump's presidential campaign, and then as a member of his transition team. He previously advised the 2016 presidential campaign of Wisconsin Governor Scott Walker."Ahead of Obamacare Repeal Rollout, Walker Stocks Up On Advisers Familiar With Capitol Hill", Roll Call.
He was nominated as FDA Commissioner in March 2017. In advance of confirmation, Gottlieb expressed his intention to recuse himself "for one year from any agency decisions involving about 20 health care companies he worked with" under an ethics agreement, including such companies as Vertex Pharmaceuticals, GSK, Bristol Myers Squibb,Thomas, Katie, "F.D.A. Nominee, Paid Millions by Industry, Says He'll Recuse Himself if Needed", New York Times, March 29, 2017. Retrieved May 10, 2017. and New Enterprise Associates.Adams, Ben, "Gottlieb confirmation as FDA commissioner warmly welcomed by biopharma", FierceBiotech, May 10, 2017. Retrieved May 10, 2017. Politico reported that Gottlieb was "expected to push the boundaries of FDA reviews and using new authority" to streamline approvals using the 21st Century Cures Act.Karlin-Smith, Sarah, and Brent Griffiths, "Gottlieb confirmed as FDA chief", Politico, May 9, 2017. Retrieved May 10, 2017. He testified before the Senate Committee on Health, Education, Labor and Pensions. There, Gottlieb equated the spread of opioid addiction with earlier epidemics of Ebola and Zika. Supporting the nominee and addressing the opioid crisis on the Senate floor before the confirmation vote, Majority Leader Mitch McConnell said in part, "I'm sure he'll be an ally to states that continue to struggle" with the crisis "because the FDA has a critical role to play." On May 9, 2017, he was confirmed by the Senate by a vote of 57–42, and he was sworn in on May 11, 2017.
As Commissioner, Gottlieb displayed "a collaborative management style, seeming to allay the concerns of some career employees who had balked at his industry ties," according to The New York Times. While Commissioner, Gottlieb testified before Congress 19 times.
On June 8, 2017, Gottlieb requested the market withdrawal of the opioid Opana ER, based on a risk associated with the illicit use of the product when the drug was inappropriately reformulated for abuse through injection. It was the first time the FDA sought to withdraw a product based on a risk associated entirely with the illicit use of a medical product. FDA later sought, and received, authority that Gottlieb had requested from Congress to be able to require the market withdrawal of opioid drugs when the agency had safety concerns that arose as a result of the illicit use of opioid drugs.
On July 28, 2017, Gottlieb delayed application deadlines on new tobacco products, including premium cigars and electronic cigarettes, to provide sufficient time to finalize regulations on how those products would be regulated by the FDA, and at the same time, announced that the FDA would take steps to regulate nicotine levels in combustible cigarettes to render the combustible cigarettes "minimally or non-addictive," and to regulate flavored tobacco products, including menthol cigarettes. The announcement caused shares of tobacco company Altria that day to initially decline by 19%.
Gottlieb approved the first gene therapy product in the U.S. on August 30, 2017, the drug tisagenlecleucel (KYMRIAH, Novartis Pharmaceuticals Corp.) for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
In December 2017, Gottlieb unveiled a policy to step up FDA's oversight of homeopathic drugs, which had previously gone largely unregulated. At the same time, the FDA issued a series of warning letters seeking to remove certain unsafe and violative homeopathic products from the market.
In March 2018, the FDA, under Gottlieb, initiated a rule to lower the amount of nicotine in cigarettes to make them less addictive—in "an unprecedented move by the agency… It's the boldest move yet against cigarette makers by the FDA, which only obtained permission to regulate tobacco products in 2009."
In August 2017, Gottlieb announced an initiative to accelerate the development of cell based therapies while also taking actions to crack down on what he called "unscrupulous" actors who were marketing unregulated stem cell therapy products that had caused some patients harm. Many of the companies that the FDA cited had been performing liposuction to remove fat from patients, isolating stem cells and then injecting those cells back into the same patients to treat various ailments. In May 2018, Gottlieb asked federal courts on opposite sides of the country to permanently stop two stem cell companies from operating after reports of patients being blinded by their treatments and released new guidelines on how the FDA would set enforcement priorities.