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Scott Gottlieb (born June 11, 1972) is an American physician and investor who became commissioner of the Food and Drug Administration (FDA) in 2017 and announced his resignation in March 2019. Prior to assuming that position, he was a clinical assistant professor at New York University School of Medicine, a resident fellow at the conservative think tank the American Enterprise Institute, the FDA Deputy Commissioner for Medical and Scientific Affairs, a venture partner with New Enterprise Associates, and a member of the policy board of the Leukemia and Lymphoma Society.

Scott Gottlieb
Scott Gottlieb official portrait.jpg
23rd Commissioner of Food and Drugs
Assumed office
May 11, 2017
PresidentDonald Trump
DeputyAmy Abernethy
Preceded byRobert Califf
Personal details
Born (1972-06-11) June 11, 1972 (age 46)
East Brunswick, New Jersey, United States
Political partyRepublican
EducationWesleyan University (BA)
Mount Sinai Medical Center
(MD)

Contents

Early life and educationEdit

Gottlieb grew up in East Brunswick, New Jersey, the son of Stanley, who is a psychiatrist, and Marsha Gottlieb.[1] 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.[2]

CareerEdit

FDA and CMS (2003-2007)Edit

Gottlieb worked for the US Food and Drug Administration (FDA) from 2002 to 2003 and 2005 to 2007.[3] He first served as a senior advisor to the FDA Commissioner and as the FDA's Director of Medical Policy Development.[4] 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 was appointed to the Senior Executive Service and granted a top secret security clearance while serving as Deputy Commissioner for Medical and Scientific Affairs from 2005 to 2007. He was a member of the Biodefense Interagency Working Group to help draft a strategic plan for U.S. biodefense countermeasures.

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.[5]

Private Sector (2007-2017)Edit

Gottlieb practiced internal medicine as an attending physician at New York University's Tisch Hospital in New York City.[6]

In 2007 Gottlieb became a venture partner at New Enterprise Associates (NEA), the world's largest venture capital firm by assets under management.[7] Gottlieb served as an active investing partner in the firm's healthcare division. He served on the boards of directors of 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,[8] healthcare reform[9] and medical innovation.[10] 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."[8] He also suggested that the EpiPen price was viewed unfairly because the list price of the drug doesn't account for rebates or discounts, and that much of the actual price paid by the purchaser is not forwarded to the manufacturer or patients. Gottlieb referred to the money received by the manufacturer of the drug as the "real" price, $274 for an EpiPen 2-pak vs. the $600 "list" price, with the difference split among various players along the pharmaceutical supply chain rather than benefiting patients by lowering their out-of-pocket costs.

He was an independent director at Tolero Pharmaceuticals[11] and Daiichi Sankyo Inc.[12] and a member of GlaxoSmithKline's product investment board.[13] 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.[14] In 2015 he served on the Board of Directors of Kure, Corp, a provider of e-juices and vaping pens.[15]

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.[4][16][17]

FDA Commissioner (2017–2019)Edit

 
Gottlieb speaks at the National Press Club in 2017

Gottlieb worked as an advisor to, and then a member of Trump's transition starting in summer 2016. He previously advised the 2016 presidential campaign of Scott Walker.[18]

He was nominated as FDA Commissioner in March 2017.[19][20][21] 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,[22], and New Enterprise Associates.[23] 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.[24] He testified before the Senate Committee on Health, Education, Labor and Pensions.[25] There, Gottlieb equated the spread of opioid addiction with earlier epidemics of Ebola and Zika.[26][27] 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." 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.[28] On May 9, 2017, he was confirmed by the Senate[23] by a vote of 57–42.[29]

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.[30]

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.[31]

On July 28, 2017, Gottlieb delayed application deadlines on new tobacco products, including premium cigars and electronic cigarettes, and announced that the FDA would take steps to regulate nicotine levels in combustible cigarettes to render the combustible cigarettes "minimally or non-addictive,"[32] causing shares of tobacco company Altria that day to initially decline by 19%.[33]

Gottlieb pursued policies to address barriers to the approval of complex generic drugs, including generic, functionally equivalent alternatives to EpiPen.[34][35][36] Under his leadership, the agency approved the first generic competitor of EpiPen.[37]

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.[38]

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.[39] On November 8, 2018, it was reported that the FDA was "expected to announce a ban on the sale of most flavored e-cigarettes in tens of thousands of convenience stores and gas stations across the country", according to senior agency officials, and "the agency will also impose such rules as age-verification requirements for online sales." The reports noted that "Gottlieb also is expected to propose banning menthol in regular cigarettes. The agency has been collecting public comments on such a prohibition, which is a major goal of the public health community but is likely to be strongly opposed by the cigarette industry." It was also reported that Gottlieb would seek to ban flavors in cigars.[40] Gottlieb stated, “I will not allow a generation of children to become addicted to nicotine through e-cigarettes.” 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."[41]

Gottlieb advanced initiatives on addressing drug pricing[42] "in ways that the agency hasn't done before."[43] He committed to make fighting opioid addiction one of his highest priorities as Commissioner.[44] Under Gottlieb's leadership, "The FDA stirred up a hornet's nest with an unprecedented request to Endo International plc to remove voluntarily its opioid pain medication, a tamper-resistant reformulation of Opana ER (oxymorphone hydrochloride), from the market."[45]

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.[46]

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.[47]

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.[48]

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.[49] Editorializing on Gottlieb's resignation The Washington Post called him "One of the Trump administration’s most competent, careful and effective senior officers."

On March 13, 2019 Gottlieb moved to restrict sales of flavored e-cigarettes to try to reduce the soaring rate of teenage vaping. The agency issued a proposal requiring that stores sequester flavored e-cigarettes to areas off limits to anyone under age 18. The proposal also called for banning the sale of many flavored cigars.[50] Under the policy the FDA would reserve the right to push companies to comply or remove their products from shelves.

Other professional activitiesEdit

Gottlieb was a member of the Public Policy Committee to the Society of Hospital Medicine[51] and was an adviser to the National Coalition for Cancer Survivorship. He has also worked as a senior policy advisor to the Administrator at the Centers for Medicare & Medicaid Services, where he worked on implementation of the Medicare Prescription Drug, Improvement, and Modernization Act and the Medicare Part D drug benefit, and helped advance the agency's coverage policies related to new medical technology.[52] He has served as an advisor to Cancer Commons.[53] He was a resident fellow at the American Enterprise Institute.[52]

WritingEdit

Gottlieb is a former member of the editorial staff of the British Medical Journal (BMJ) and was a member of the editorial board of a section of the Journal of the American Medical Association (JAMA) from 1996 to 2001.[54] He is a regular contributor to the editorial page of the Wall Street Journal and writes regularly for Forbes.[55] Gottlieb was a frequent and early critic of the Patient Protection and Affordable Care Act.[56] 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.[57] Gottlieb argued that patients who received Medicaid had worse outcomes, including death, with conditions like head and neck cancer than patients who had no insurance coverage at all.[58] Critics said that his article was based on "a classic misunderstanding: confusing correlation for causation," a limitation explicitly mentioned in all the papers he cited. Politifact called it "mostly false."[59][60][61] Gottlieb appeared regularly on CNBC[62] and Fox News.[63]

RecognitionEdit

  • Fortune Magazine identified Gottlieb as one of its 2018 "The World's 50 Greatest Leaders," ranking him number 6.[64] 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."[65]
  • Time Magazine named Gottlieb one of its "50 People Transforming Healthcare in 2018"[66] 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."[67]
  • 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."[68]
  • In October 2018, Gottlieb was elected a member of the National Academy of Medicine.[69]
  • The American Medical Association presented Gottlieb with its 2019 Nathan Davis Award for Outstanding Government Service.[70]

Personal lifeEdit

Gottlieb is a survivor of Hodgkin's lymphoma.[71] He is married and has three daughters.[1]

ReferencesEdit

  1. ^ a b Straehley, Steve; Wallechinsky, David (April 24, 2017). "Commissioner of the Food and Drug Administration: Who Is Scott Gottlieb?". AllGov. Retrieved May 3, 2017.
  2. ^ "Allyson Nemeroff, Scott Gottlieb". The New York Times. June 13, 2004. Retrieved January 13, 2017.
  3. ^ "Meet Scott Gottlieb, M.D., Commissioner of Food and Drugs". FDA. Retrieved October 29, 2018.
  4. ^ a b "Dr. Scott Gottlieb". intelligencesquaredus.org. March 1, 2016. Retrieved January 13, 2017.
  5. ^ Morrow, Brendan (March 10, 2017). "Scott Gottlieb: 5 Fast Facts You Need to Know". Heavy. Retrieved May 3, 2017.
  6. ^ "Scott Gottlieb M.D." Bloomberg. Retrieved 7 March 2019.
  7. ^ "NEA Venture Partner Scott Gottlieb, M.D., Nominated to be FDA Commissioner". nea.com. March 11, 2017. Retrieved September 22, 2018.
  8. ^ a b 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.
  9. ^ Gottlieb, 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.
  10. ^ 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.
  11. ^ "Board of Directors". toleropharma.com. Retrieved January 13, 2017.
  12. ^ "Company Daiichi Sankyo, Inc". us-companies.info. Retrieved January 13, 2017.
  13. ^ "Scott Gottieb's LinkIn profile". Retrieved February 7, 2018.
  14. ^ "Scott Gottlieb {first-person bio}", forbes.com. Retrieved March 10, 2017.
  15. ^ Faux, Zeke; Lawrence, Dune; Kaplan, Jennifer (April 18, 2017). "Vaping Venture Poses Potential Conflict for Trump's FDA Nominee". www.bloomberg.com. Retrieved December 28, 2018.
  16. ^ "Scott Gottlieb, MD - NEA - New Enterprise Associates". nea.com. Archived from the original on November 21, 2016. Retrieved January 13, 2017.
  17. ^ "Food and Drug Law Institute". National Health Council. Retrieved September 22, 2018.
  18. ^ "Ahead of Obamacare Repeal Rollout, Walker Stocks Up On Advisers Familiar With Capitol Hill", Roll Call.
  19. ^ Neel, Joe (March 10, 2017). "Trump Chooses Dr. Scott Gottlieb To Head Food And Drug Administration". NPR. Retrieved March 10, 2017.
  20. ^ Thomas, Katie (March 10, 2017). "F.D.A. Official Under Bush Is Said to Be Trump's Choice to Lead Agency". New York Times. Retrieved March 10, 2017.
  21. ^ Cunningham, Paige Winfield (March 10, 2017). "Trump expected to pick Scott Gottlieb to head FDA". Washington Examiner. Retrieved March 10, 2017.
  22. ^ 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.
  23. ^ a b Adams, Ben, "Gottlieb confirmation as FDA commissioner warmly welcomed by biopharma", FierceBiotech, May 10, 2017. Retrieved May 10, 2017.
  24. ^ Karlin-Smith, Sarah, and Brent Griffiths, "Gottlieb confirmed as FDA chief", Politico, May 9, 2017. Retrieved May 10, 2017.
  25. ^ Siegel, Marc (April 7, 2017). "A vote for Scott Gottlieb and medical discovery". Fox News. Retrieved May 10, 2017.
  26. ^ "FDA nominee says nation's opioid crisis is as serious as Ebola, Zika threats". Washington Post. Retrieved July 15, 2017.
  27. ^ Anna Edney (April 5, 2017). "Opioid Epidemic Is FDA's Top Priority, Says Pick to Head Agency". Bloomberg. Retrieved July 27, 2017.
  28. ^ Karlin-Smith, Sarah, and Brent Griffiths, "Gottlieb confirmed as FDA chief," Politico, May 9, 2017. Retrieved May 10, 2017.
  29. ^ Thomas, Katie (May 10, 2017). "Senate Confirms Scott Gottlieb to Head F.D.A." The New York Times. p. A13. Retrieved July 29, 2017.
  30. ^ Kaplan, Sheila; Thomas, Katie (February 11, 2018). "F.D.A. Chief Goes Against the Administration Stereotype". The New York Times. ISSN 0362-4331. Retrieved December 28, 2018.
  31. ^ "FDA Seems Removal of Opioid Painkiller from the Market". The Washington Post. June 8, 2017.
  32. ^ Chon, Gina (July 28, 2017). "A Rare Victory for Science in an F.D.A. Move" – via NYTimes.com.
  33. ^ Kaplan, Sheila (July 29, 2017). "F.D.A. Delays Rules That Would Have Limited E-Cigarettes on Market". The New York Times. p. A13. Retrieved July 29, 2017.
  34. ^ Commissioner, Office of the. "Press Announcements - Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices". www.fda.gov. Retrieved September 30, 2018.
  35. ^ Commissioner, Office of the. "Press Announcements - Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA's ongoing efforts to increase access to complex generic drugs". www.fda.gov. Retrieved September 30, 2018.
  36. ^ Commissioner, Office of the. "FDA Voices: Perspectives From FDA Experts". www.fda.gov. Retrieved September 30, 2018.
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  41. ^ Article, News (November 17, 2019). "The FDA's New Tobacco Rules are a Victory for Public Health". The Washington Post. Retrieved December 5, 2018.
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  45. ^ "In its first big move under Gottlieb, FDA targets Endo International's Opana ER". BioWorld. Retrieved July 27, 2017.
  46. ^ Wan, William (May 9, 2018). "FDA Seeks Injunction To Stop Two Stem Cell Companies After Patients Blinded". Washington Post. Retrieved March 5, 2019.
  47. ^ Bursztynsky, Jessica (February 11, 2019). "FDA plans to strengthen oversight of dietary supplements market". www.cnbc.com. Retrieved February 19, 2019.
  48. ^ "Statement from Congressman Frank Pallone". March 5, 2019. Retrieved March 7, 2019.
  49. ^ McGinley, Laurie; Bernstein, Lenny (March 5, 2019). "FDA Commissioner Gottlieb, who raised alarms about teen vaping, resigns". Washington Post. Retrieved March 5, 2019.
  50. ^ "F.D.A. Moves to Restrict Flavored E-Cigarette Sales to Teenagers". March 13, 2019. Retrieved March 13, 2019.
  51. ^ Medicine, Society of Hospital. "Public Policy Committee - Society of Hospital Medicine". hospitalmedicine.org. Retrieved January 13, 2017.
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  53. ^ "Emeritus Advisory Board". Retrieved March 10, 2017.
  54. ^ "11 Numbers to Know About Scott Gottlieb". U.S. News & World Report. Kaiser Health News. March 14, 2017. Retrieved May 3, 2017.
  55. ^ Gottlieb, Scott. "Scott Gottlieb - Medical Innovation". forbes.com. Retrieved January 13, 2017.
  56. ^ Gottlieb, Scott (May 12, 2009). "How ObamaCare Will Affect Your Doctor". Retrieved December 26, 2017 – via www.WSJ.com.
  57. ^ Astrue, Scott Gottlieb And Michael. "Gottlieb and Astrue: ObamaCare's Technology Mess". WSJ.com. Retrieved December 26, 2017.
  58. ^ "Medicaid is worse than no coverage at all".
  59. ^ Medicaid Worsens Your Health? That’s a Classic Misinterpretation of Research, By AARON E. CARROLL and AUSTIN FRAKT, July 3, 2017
  60. ^ Are You Better Off With Medicaid Than No Insurance? A Landmark Study Says Yes (Guest Opinion), By Jonathan Cohn, Kaiser Health News and New Republic, July 7, 2011
  61. ^ Are Medicaid patients more likely to die than uninsured, as Heritage Action CEO says? By Amy Sherman, Politifact, June 28, 2017
  62. ^ Gottlieb, Scott (August 29, 2016). "Former FDA official explains why drug makers charge outrageous prices". cnbc.com. Retrieved January 13, 2017.
  63. ^ "Dr. Scott Gottlieb". foxnews.com. January 13, 2017. Retrieved January 13, 2017.
  64. ^ Fortune Magazine, April 19, 2018
  65. ^ "The World's 50 Greatest Leaders". Fortune. Retrieved December 28, 2018.
  66. ^ "Why Dr. Scott Gottlieb Is One of the 50 Most Influential People in Health Care". Time. Retrieved January 21, 2019.
  67. ^ "Scott Gottlieb - POLITICO 50 2018". POLITICO.
  68. ^ "Gottlieb sets a new standard for FDA commissioner". Modern Healthcare. Retrieved January 21, 2019.
  69. ^ "National Academy of Medicine Elects 85 New Members". www8.nationalacademies.org. October 15, 2018. Retrieved February 26, 2019.
  70. ^ "Scott Gottlieb - Nathan Davis Award for Government Service". AMA.
  71. ^ LaMotte, Sandee (April 4, 2017). "Scott Gottlieb: Conflicts surround Trump's FDA pick". CNN. Retrieved May 3, 2017.

External linksEdit

Political offices
Preceded by
Robert Califf
Commissioner of Food and Drugs
2017–present
Incumbent