Scott Gottlieb (born June 11, 1972) is an American physician and investor who previously served as the 23rd commissioner of the Food and Drug Administration (FDA) from May 2017 until April 2019.

He is presently a senior fellow at the conservative think tank the American Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA),[1][2] and a member of the board of directors of drug maker Pfizer, Inc and gene sequencing company Illumina, Inc.[3] [4] Gottlieb is a contributor to cable financial news network CNBC and the CBS News program Face the Nation.

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.

[12][13] 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.

"[18] Gottlieb was an independent director at Tolero Pharmaceuticals[23] and Daiichi Sankyo Inc.[24] and a member of GlaxoSmithKline's product investment board, which made decisions on which drugs GSK would take forward in development.

[36] 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.

[42] 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.

[44] On June 8, 2017, Gottlieb requested[45] 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.

[50] 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.

[58] 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.

[59] Gottlieb also announced an initiative to accelerate development of FDA regulated cell and gene therapies in anticipation of a surge of new applications for commercial products.

Among other things, Gottlieb said the FDA would add 50 additional reviewers to its staff, and issue new guidance documents that would lay out the pathway for development of different kinds of products such as gene therapies for inherited blood disorders and neurodegenerative diseases.

[61][62] In September 2018, citing an epidemic of use of electronic cigarettes by teenagers, Gottlieb announced that the FDA would seek to ban flavors in e-cigs as a way to reduce their appeal to youth.

with The Washington Post editorializing that the new rules "represent an extraordinary step in the fight against nicotine addiction, one that, if successful, would become one of the nation's greatest public-health victories.

Gottlieb also called into question the motives behind the decision by Altria to take a minority stake in Juul and accused the manufacturer of reneging on commitments and representations it had made to FDA.

"[71] In November 2018, the FDA implemented a new framework, in collaboration with the Department of Defense, to expedite the development of medical products intended to support American soldiers on the battlefield.

[73][74] The episode exposed an unusual "turf war" that pitted Gottlieb and the FDA against Pentagon officials[75] and "puts on public display an internal rift within the administration and in Republican congressional ranks.

He undertook a series of new steps to rationalize prescribing as a way to reduce exposure to opioid drugs in order to cut the rate of new addiction.

[82] Under Gottlieb's leadership, "The FDA stirred up a hornet's nest with an unprecedented request to Endo International to remove voluntarily its opioid pain medication, a tamper-resistant reformulation of Opana ER (oxymorphone hydrochloride), from the market.

[88][89][90] At the time of his resignation, Politico observed, "FDA leaders have typically focused much of their attention on a handful of medical topics, but Gottlieb has been active and aggressive on many issues as commissioner without hewing to a strictly conservative or liberal ideology.

"[91] Gottlieb was called "an unusually activist regulator in the Trump administration whose agenda touched everything from tobacco to trans-fats," and he "wasn't afraid to speak on topics normally seen as a third rail for a FDA commissioner, including drug pricing… His most high-profile advocacy came in the area of youth smoking, where he aggressively pressed e-cigarette manufacturers and retailers to halt marketing to teens.

"[92] At the same time, other reports observed that Gottlieb left the FDA with some of his signature tobacco policies still awaiting full implementation, including his plans to ban menthol in cigarettes.

He sought and received money from Congress to hire dozens of more staff to inspect 100,000 packages per year that had been flagged as suspicious by customs agents, up from a prior capacity of roughly 40,000.

[115][116][117] On February 12, 2020, Gottlieb testified before the Senate Committee on Homeland Security and Governmental Affairs on preparedness for the novel coronavirus and future pandemic threats.

[118][119] On March 29, 2020, Gottlieb and several public health experts published "National Coronavirus Response: A Road Map to Reopening", providing specific actions for navigating through the current COVID-19 pandemic in the United States.

In that op-ed, Gottlieb called for a pathway toward federal legalization of cannabis that would allow, among other reforms, easier access to the compound for research while exerting stricter and more uniform regulation over products.

[140][141] In a separate editorial writing in The Washington Post, Gottlieb called on Congress and the FDA to create a framework for the legal sale of regulated Cannabidiol (CBD), a chemical found in cannabis plants that is used to treat certain medical conditions.

"[145] In an Op Ed in the Washington Post in 2024 Gottlieb called for stricter federal regulation of high-risk laboratory research, and he was among those during the Covid pandemic who argued that the virus may have been the result of a lab leak.