Scott Gottlieb facts for kids

Quick facts for kids Scott Gottlieb
Gottlieb in 2017
23rd Commissioner of Food and Drugs
In office May 11, 2017 – April 5, 2019
President	Donald Trump
Deputy	Anna Abram
Preceded by	Robert Califf
Succeeded by	Norman Sharpless
Personal details
Born	(1972-06-11) June 11, 1972 (age 52) East Brunswick, New Jersey, U.S.
Political party	Republican
Education	Wesleyan University (BA) Mount Sinai School of Medicine (MD)

Scott Gottlieb (born June 11, 1972) is an American physician, investor, and author who 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), a member of the board of directors of drug maker Pfizer, Inc and gene sequencing company Illumina, Inc. and 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, Gottlieb 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. His forthcoming book, The Miracle Century: Making Sense of the Cell Therapy Revolution, traces the scientific achievements that propelled progress in cell therapies.

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. He was previously a resident fellow at AEI from 2007 to 2017, prior to joining the FDA as Commissioner in May 2017.

Early life and education

Gottlieb grew up in East Brunswick, New Jersey, the son of Stanley, who is a psychiatrist, and Marsha Gottlieb. He 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. He is Jewish.

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 key parts of the planning effort on a bird flu vaccine in 2005, because he had done consulting work for companies 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.

In 2016, Gottlieb testified before committees of the United States House of Representatives and the United States Senate on issues related to FDA regulation of drug prices, healthcare reform and medical innovation. During congressional investigations of the rise of the price of EpiPen, Gottlieb presented testimony arguing that generic drug companies set prices according to market demand, and 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 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."

He 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 T.R. Winston, a Los Angeles-based merchant bank with a focus on healthcare. Gottlieb 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)

Gottlieb speaks at the National Press Club in 2017

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.

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, and New Enterprise Associates. 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. 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.

Gottlieb approved the first gene therapy product in the U.S. on August 30, 2017.

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 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, while helping to advance development of effective products.

Gottlieb pursued policies to address barriers to the approval of complex generic drugs, including generic, functionally equivalent alternatives to EpiPen. Under his leadership, in August 2018, the FDA approved the first generic competitor of EpiPen, and later, in January 2019, the agency approved a generic competitor to the asthma drug Advair. Of the agency's more than 1,000 generic approvals in 2018, about 14 percent were for "complex generic drugs," or drugs that are particularly difficult to "genericize."

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. Gottlieb had fought to maintain FDA control over the review and approval of medical products intended to support the war fighter after the Pentagon had sought to acquire that authority for itself as part of the National Defense Authorization Act. "I'm fully committed to trying to expedite products for the war fighter, and ... if they pass the language that has been put forward — the alternative language — we will commit to very quickly putting in place the implementing guidance to stand up that process," Gottlieb said as the Pentagon's version of the provision was moving through the House and the Senate. Ultimately, the compromise was to retain the authority with the FDA but for the FDA to commit to offer products intended for the battlefield a higher priority of review, reflecting the compromise provision that Gottlieb had put forward. The episode exposed an unusual "turf war" that pitted Gottlieb and the FDA against Pentagon officials and "puts on public display an internal rift within the administration and in Republican congressional ranks."

Gottlieb advanced initiatives on addressing drug pricing, "in ways that the agency hasn't done before." In December 2018, Gottlieb announced a plan to transition the biologicals currently regulated as drugs, including insulin, to be regulated under the Public Health Services Act as a way to open up these drugs to competition from lower cost biosimilars.

In February 2019, Gottlieb took action to curtail the marketing of 17 dietary supplements that were making unlawful and unproven medical claims to treat Alzheimer's disease and, at the same time, unveiled a set of policy steps to strengthen the FDA's oversight of dietary supplements that was billed as the most significant modernization of the agency's regulation of supplements in 25 years.

In Spring 2019, Gottlieb took a series of actions to create a new framework for the development and FDA oversight of artificial intelligence medical devices. The stated goal was to allow products that sought to make regulated medical claims to come to the market through a predictable, negotiable regulatory process.

In March 2019, Gottlieb pressed for the market withdrawal of certain cosmetics because they were found to contain asbestos, at the same time that he announced a set of new proposals to strengthen oversight of the cosmetics industry, winning praise from legislators who had been pressing for similar reforms.

On March 5, 2019, Gottlieb announced his resignation as FDA Commissioner, effective in about a month. He said that he wanted to spend more time with his family. 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. It’s an approach that’s won him praise from many in the health sector."

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…".

On March 27, 2019, Gottlieb advanced a new federal rule stipulating, for the first time, that centers that provide mammograms to screen for breast cancer will have to tell women whether they have dense breast tissue, which can increase the risk of cancer and mask tumors. The rule marked the first changes proposed in 20 years to the FDA's regulations on mammography.

While commissioner, Gottlieb undertook a substantial expansion of the FDA’s interdiction activities inside the international mail facilities. 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. The FDA also launched a new collaboration with Customs and Border Protection to step up joint inspectional activities.

Private sector (2019–present)

Upon leaving the FDA, Gottlieb returned to the American Enterprise Institute. In May 2019, he returned to New Enterprise Associates as a partner in the firm's healthcare practice, where he helped lead the firm's investments in National Resilience, Comanche Biopharma, and Xaira Therapeutics; and joined the board of two additional NEA portfolio companies, Aetion, Inc. and Tempus AI. Gottlieb was elected as an independent member of the board of directors of Pfizer, Inc. in June 2019. He joined the Illumina, Inc. board of directors in February 2020 and the National Resilience, Inc. board of directors in November 2020, where he was one of the original venture investors. He is also a member of the boards of trustees of the Mount Sinai Health System and Wesleyan University. Gottlieb is a regular contributor to the Journal of the American Medical Association's Health Forum.

With the advent of the COVID-19 reaching the United States and a great deal of misinformation being presented or correct information not being presented, Gottlieb has spoken out with public information on the virus on many venues. 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. 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. Since April 2020, Gottlieb has advised several governors on the COVID-19 pandemic. He joined Maryland Governor Larry Hogan's COVID-19 response team and Massachusetts Governor Charlie Baker's COVID-19 advisory board. He has also advised Connecticut Governor Ned Lamont as a member of the Reopen Connecticut Advisory Group. On November 20, 2020, it was announced that Gottlieb would serve on Montana's Governor-elect Greg Gianforte's COVID-19 task force. Gottlieb was criticized by Substack author Alex Berenson for contacting Twitter; Berenson alleged it was to get him removed from the platform.

Other professional activities

Gottlieb was a member of the Public Policy Committee to the Society of Hospital Medicine and an editorial board member of the journal Value Based Cancer Care. He served as an adviser to the National Comprehensive Cancer Network, the National Coalition for Cancer Survivorship. He is also a member of the advisory board to the Milken Institute's FasterCures and the National Institute for Health Care Management (NIHCM). Before first joining the FDA, and in between each of his three tours of government service, Gottlieb was a fellow at the American Enterprise Institute.

Writing

Gottlieb was a staff writer of the British Medical Journal (The BMJ) from 1997 to 2005 and a senior editor of the Pulse section of the Journal of the American Medical Association (JAMA) from 1996 to 2001. He is a Contributor to the Journal of the American Medical Association's Health Forum and a regular contributor to the editorial page of The Wall Street Journal and The Washington Post and wrote regularly for Forbes. In 2020 and 2021, Gottlieb authored a weekly column for the editorial page of the Wall Street Journal. Many of his articles have addressed the intersection of public policy and the practice of medicine. Gottlieb was a frequent and early critic of the Patient Protection and Affordable Care Act. He wrote an editorial in The Wall Street Journal, on the day of the health plan's launch, predicting the ensuing problems with the healthcare.gov website. Gottlieb argued that studies showed some patients who received Medicaid had worse outcomes, including death, when they had certain conditions like head and neck cancer, compared to patients who had no insurance coverage at all. He observed that in these cases, uninsured patients had access to newer medicines through free patient assistance programs, whereas federal law prevented Medicaid patients from getting access to these free drug programs because they were enrolled in Medicaid. As a result, Medicaid patients depended on whether or not these newer and typically costlier medicines were covered by their state Medicaid programs, which, in the cases Gottlieb cited, were not available. Critics said that his article was based on "a classic misunderstanding: confusing correlation for causation," a limitation explicitly mentioned in papers he cited.

In January 2020, Gottlieb wrote several articles warning about the spread of COVID-19 in the United States. On January 23, Gottlieb wrote an Op-Ed titled "What must be done to head off the coronavirus threat" in The Washington Post. On January 27, Gottlieb wrote an Op-Ed titled "We need to prepare for US outbreak of Wuhan coronavirus." and on January 28, Gottlieb and Luciana Borio wrote an opinion which appeared in the editorial opinion of The Wall Street Journal entitled "Act Now to Prevent an American Epidemic."

Gottlieb examined the systemic shortcomings of the U.S. response to the COVID-19 pandemic in his new book, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic, which was released on September 21, 2021 by HarperCollins. Uncontrolled Spread debuted at No.5 on The New York Times Best Seller list for Hardcover Nonfiction and at No.6 for Combined Print & E-Book Nonfiction. The book also debuted at No.9 on The Wall Street Journal Best Seller list for Hardcover Nonfiction and No.8 on the Publishers Weekly hardcover Nonfiction Best Seller list.

Recognition

• Fortune magazine identified Gottlieb as one of its 2018 "The World's 50 Greatest Leaders," ranking him number 6. The magazine stated "Gottlieb has gotten credit for being transparent about FDA steps—and, more important, for using his bully pulpit without being a bully." Fortune magazine selected Gottlieb again in its 2019 survey, ranking him number 50 among its "World's 50 Greatest Leaders."
• Time magazine named Gottlieb one of its "50 People Transforming Healthcare in 2018," noting that "Gottlieb gained supporters for grounding his tough policies in scientific evidence."
• In naming Gottlieb as one of its "50 Politicos for 2018," the publication Politico noted that "This isn't the Scott Gottlieb many people had expected. As a Bush administration official, the physician was an avowed free-marketer, leading liberals to worry he would aggressively try to dismantle the FDA's vast regulatory apparatus. But since his confirmation, as counterparts at other federal agencies have focused on overturning or undermining the rules they inherited, Gottlieb has struck a genuine balance at the FDA."
• In naming Gottlieb the "Most Influential Physician Executive and Leader" in its 2018 annual survey of 50 physician executives, Modern Healthcare noted that "an unprecedented level of transparency and public disclosure has garnered support from across the industry." In 2019, Modern Healthcare again named Gottlieb the most influential physician executive and leader, noting "Gottlieb accomplished a rare feat during his two-year tenure as head of the Food and Drug Administration—he earned praise from Republicans and Democrats alike." Modern Healthcare observed "although he stepped down in April, stakeholders hope the former commissioner's endeavors will live on and influence future agency heads."
• Modern Healthcare also named Gottlieb nineteenth in its survey of the 100 most influential people in healthcare, in 2018, fifty-fifth in 2019, and fifty-fourth in 2021.
• In October 2018, Gottlieb was elected a member of the National Academy of Medicine.
• The American Medical Association presented Gottlieb with its 2019 Dr. Nathan Davis Award for Outstanding Government Service.
• In September 2019, Gottlieb received Cancer Research Leadership Award from Friends of Cancer Research in recognition of his leadership in the regulatory and scientific innovations.
• Gottlieb was recognized on Modern Healthcare's list of 50 Most Influential Clinical Executives for 2020. The magazine stated that Gottlieb "has maintained a high—and influential—profile. During the COVID-19 pandemic, he has been active in the media—both traditional and social—talking about a host of challenges facing the nation, from the supply chain to the importance of a test-trace-isolate protocol."
• Medical Marketing & Media (MM&M) and PRWeek recognized Gottlieb on their 2020 Health Influencer 50 list, ranking him number 4. They noted that "In a year that will likely be remembered for medical misinformation and the proliferation of science-deniers, Dr. Scott Gottlieb continues to stand out as one of the clearest and most direct communicators of all things health-related."
• Gottlieb was named one of "Washington's 2021 Most Influential People" by Washingtonian.
• In May 2021, Gottlieb received an honorary Doctor of Science degree from Wesleyan University in recognition of his achievements in dealing with "drug pricing, as well as his willingness to speak up and educate others on the nature of the COVID-19 virus." In 2022, he was inducted into the East Brunswick High School "Hall of Fame," where he graduated in 1990.
• Gottlieb was recognized by Modern Healthcare as one of 2021's 100 Most Influential People in Healthcare.
• Mediaite recognized Gottlieb on their Most Influential in News Media 2021 list, ranking him number 24. They noted that Gottlieb "established himself as one of the most valuable experts to follow on the Covid-19 pandemic in 2021. Gottlieb's regular appearances on the CBS Sunday show Face the Nation, as well as CNBC's Squawk Box, were refreshing in their honesty and sharp analysis. Unlike many in the Covid pundit class, Gottlieb did not shy away from challenging orthodoxy. He also called out both sides of the aisle, blaming his former boss for politicizing Covid while blaming the Biden administration for its mixed messaging surrounding the pandemic."
• Gottlieb was named one of Washington, D.C.'s 500 Most Influential People Shaping Policy in 2022 and 2023 by Washingtonian.
• FiercePharma named Gottlieb one of "The 22 most influential people in the fight against COVID-19," noting that Gottlieb "emerged as an important and trusted voice" and "Through the pandemic, Gottlieb has been a vocal advocate of science and an eager educator explaining complex concepts about the virus, vaccines and treatments."
• He was the 2024 recipient of The Mount Sinai School of Medicine Alumni Special Recognition Award

Personal life

Gottlieb is a survivor of Hodgkin lymphoma. He is married and has three daughters.