Scott Gottlieb

Scott Gottlieb
Commissioner of Food and Drugs
Assumed office
May 11, 2017
President Donald Trump
Deputy Rachel Sherman
Preceded by Robert Califf
Personal details
Born (1972-06-11) June 11, 1972
East Brunswick, New Jersey,
U.S.
Political party Republican
Education Wesleyan University (BA)
Mount Sinai Medical Center
(MD)

Scott Gottlieb (born June 11, 1972) is an American physician who serves as commissioner of the Food and Drug Administration (FDA).[1][2][3][4] Prior to assuming his current 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, an internist at Tisch Hospital[5], the FDA Deputy Commissioner for Medical and Scientific Affairs[6], an investing partner at the venture capital firm New Enterprise Associates[7], and a member of the policy board of the Leukemia and Lymphoma Society.[7]

Early life and education

Gottlieb grew up in East Brunswick, New Jersey, the son of Stanley, who is a psychiatrist, and Marsha Gottlieb.[8] 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 was married in a Jewish wedding ceremony.[9]

Career


FDA Deputy Commissioner for Medical and Scientific Affairs (2005 - 2007)

Gottlieb worked for the federal government of the United States in the Food and Drug Administration (FDA) from 2005 to 2007.[10] He helped initiate the early development of the FDA's generic drug user fee program and the agency's release of the Physician Labeling Rule. He also 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 during his appointment as the FDA's Deputy Commissioner for Medical and Scientific Affairs. He was also a member of the White House Biodefense Interagency Working Group, which was convened after the September 11 attacks to help draft a strategic plan for the development of U.S. biodefense countermeasures. While working for the FDA, Gottlieb recused himself from working on planning for a possible bird flu because he had done consulting work for companies whose products may be used to combat the bird flu.[11] Before becoming the FDA's Deputy Commissioner, Gottlieb served as a senior advisor to the FDA Commissioner and as the FDA's Director of Medical Policy Development.[12] In 2013, Gottlieb was appointed by Senate Minority Leader Mitch McConnell to serve as a member of the Federal Health IT Policy Committee which advises the U.S. Department of Health and Human Services and is responsible for making recommendations on the meaningful use standards as part of the HITECH Act.[13]

New Enterprise Associates (2007 - 2017)

Following his departure from the Food and Drug Administration in 2007, Gottlieb became a partner at New Enterprise Associates (NEA), the largest venture capital firm in the world in 2007, by assets under management.[14] NEA is a US-based firm specialising in global venture funding of companies in the technology and healthcare sectors at various stages of development, and has raised the largest venture funds in history several times, including funds of over $2 billion in 2006 and 2009.[15] Gottlieb served as an active investing partner in the firm's healthcare division until his appointment as FDA Commissioner in 2017 following his work for President-elect Donald Trump's transition team in 2016 and nomination for the position in 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[16], healthcare reform[17], and medical innovation.[18] During congressional investigations of the precipitous rise of the price of the life-saving drug EpiPen, Gottlieb presented testimony arguing that generic drug companies appropriately set prices according to market demand, and that, in fact, the generic drug industry is excessively burdened by regulation including through "price setting". These regulations, he argued, made it especially hard to bring forward generic copies of complex drugs, including drugs coupled to a device delivery system -- a category of medicines that includes EpiPen. He also addressed the price of EpiPen specifically in his testimony by suggesting that the drug price was being 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. Gottlieb refers 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. Those rebates, he has argued, are not benefiting patients, but instead, benefit a series of middlemen involved in the drug supply chain.[19] His testimony also argued that patients are adversely affected by drug regulations enforced by the FDA upon generic drug manufacturers that make it difficult to pursue generic copies of complex drugs like drug device combinations, such as EpiPen, and that such excessive regulations "undermine the competitive opportunities that could help inspire more choice and competition, and help lower costs".[16] Since joining the FDA as the agency's Commissioner, Gottlieb has pursued new policies to address these barriers to the approval of complex generic drugs, like copies of EpiPen.[20][21][22] The agency recently approved the first generic version of EpiPen.[23] Gottlieb also served on the editorial board of the Food and Drug Law Institute's publication entitled "Food and Drug Policy Forum", which is an electronic publication that "provides for the exchange of ideas and recommendations on cutting-edge state, national, and international food and drug law and policy issues" and serves as a vector for discussion of regulatory policy in the food, drug, and medical device industry during his tenure at NEA, before being appointed FDA commissioner.[12][24][25]

FDA Commissioner (2017 - Present)

Gottlieb speaks at the National Press Club in 2017

In 2016, members of President-elect Donald Trump's transition team said Trump was considering Gottlieb to head the FDA as its Commissioner.[26] Gottlieb worked as an advisor to, and then a member of Trump's transition starting in the summer of 2016. He was previously a senior advisor to the 2016 presidential campaign of Wisconsin Governor Scott Walker.[27] In early March 2017, news of the nomination plan emerged.[2]

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, Cell Biotherapy, GSK, Bristol-Myers Squibb,[28] New Enterprise, TR Winston, MedAvante and Glytec.[29] The nominee testified before Committee on Health, Education, Labor and Pensions (HELP).[30] There, Gottlieb equated the spread of opioid addiction with the previous epidemics of Ebola and Zika virus.[31][32] 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.[33] On May 9, 2017, Gottlieb was confirmed by the Senate[29] by a vote of 57–42.[34]

On July 28, 2017, Gottlieb delayed application deadlines on newly deemed 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",[35] causing shares of tobacco company Altria that day to initially decline by 19%.[36] The New York Times called the action a "marked departure from the White House's rejection of evidence on climate change and its stated zeal for deregulation," noting that "The Food and Drug Administration is turning out to be the odd agency defying corporate interests."[35] In an editorial, the editors of the Washington Post called the action "one of the most important public-health initiatives of the century" and "an ambitious long-term strategy to finally end tobacco's cycle of addiction and death, a scourge that has taken the lives of millions of Americans over centuries of cultivation and consumption."[37] 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.[38]

As FDA Commissioner, Gottlieb has advanced initiatives on addressing drug pricing[39] "in ways that the agency hasn't done before" according to the Wall Street Journal.[40] He committed to make fighting the crisis of opioid addiction one of his highest priorities as Commissioner.[41] 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."[42] In December 2017 Gottlieb unveiled a policy to step up FDA's oversight of homeopathic drugs, which had previously gone largely unregulated by the agency, to "target products posing the greatest safety risks, including those containing potentially harmful ingredients or being marketed for cancer, heart disease and opioid and alcohol addictions."[43] In a front-page profile, the New York Times noted that Gottlieb "Goes Against the Administration Stereotype" by displaying "a collaborative management style, seeming to allay the concerns of some career employees who had balked at his industry ties." Fortune Magazine identified Gottlieb as one of "The World's 50 Greatest Leaders" in 2018 for its annual survey, ranking him number 6.[44] The magazine noted that "Gottlieb has gotten credit for being transparent about FDA steps—and, more important, for using his bully pulpit without being a bully."

Other Professional Activities

Gottlieb was a member of the Public Policy Committee to the Society of Hospital Medicine[45] and was an adviser to the National Coalition for Cancer Survivorship. He has been a venture partner at New Enterprise Associates since 2007[24] and was an independent director at Tolero Pharmaceuticals[46] and Daiichi Sankyo Inc.[47] and a member of GlaxoSmithKline's product investment board.[48] 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.[49]

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.[7] He has served as an advisor to Cancer Commons.[50]

Writing

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.[51]

He is a regular contributor to the editorial page of the Wall Street Journal and writes regularly for Forbes.[52] In his various writings, Gottlieb was a frequent and early critic of the Affordable Care Act.[53] 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.[54]

Gottlieb wrote another editorial in the Wall Street Journal arguing 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.[55] 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".[56][57][58]

Gottlieb also appears regularly on CNBC[59] and Fox News.[60]

Personal life

Gottlieb is a survivor of Hodgkin's lymphoma.[1] He is married and has three daughters.[8]

References

  1. 1 2 LaMotte, Sandee (April 4, 2017). "Scott Gottlieb: Conflicts surround Trump's FDA pick". CNN. Retrieved 3 May 2017.
  2. 1 2 Neel, Joe (March 10, 2017). "Trump To Nominate Dr. Scott Gottlieb To Head Food And Drug Administration". NPR. Retrieved March 10, 2017.
  3. ↑ Thomas, Katie, "F.D.A. Official Under Bush Is Said to Be Trump’s Choice to Lead Agency", New York Times, March 10, 2017. Retrieved 2017-03-10.
  4. ↑ Cunningham, Paige Winfield, "Trump expected to pick Scott Gottlieb to head FDA", Washington Examiner, March 10, 2017. Retrieved March 10, 2017.
  5. ↑ Dalzell, Michael D. (2011). "A Conversation With Scott Gottlieb, MD: The impact of health care reform on access to biologics, health policy, and managed care". Biotechnology Healthcare. 8 (3): 19–22. PMC 3278114. PMID 22479219.
  6. ↑ "Deputy Commissioners". FDA. Retrieved September 10, 2016.
  7. 1 2 3 "Scott Gottlieb". American Enterprise Institute. Retrieved September 10, 2016.
  8. 1 2 Straehley, Steve; Wallechinsky, David (April 24, 2017). "Commissioner of the Food and Drug Administration: Who Is Scott Gottlieb?". AllGov. Retrieved May 3, 2017.
  9. ↑ "Allyson Nemeroff, Scott Gottlieb". The New York Times. June 13, 2004. Retrieved January 13, 2017.
  10. ↑
  11. ↑ Morrow, Brendan (March 10, 2017). "Scott Gottlieb: 5 Fast Facts You Need to Know". Heavy. Retrieved 3 May 2017.
  12. 1 2 "Dr. Scott Gottlieb". intelligencesquaredus.org. 1 March 2016. Retrieved January 13, 2017.
  13. ↑ "Health IT Policy Committee - FACA". healthit.gov. Retrieved January 13, 2017.
  14. ↑ "NEA Venture Partner Scott Gottlieb, M.D., Nominated to be FDA Commissioner". nea.com. March 11, 2017. Retrieved September 22, 2018.
  15. ↑ Dan Primack (November 7, 2011). "NEA: The VC World's best-kept secret". Fortune. Archived from the original on April 3, 2015. Retrieved September 22, 2018.
  16. 1 2 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.
  17. ↑ 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.
  18. ↑ 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.
  19. ↑ Gottlieb, Scott. "How Congress Can Make Drug Pricing More Rational". Forbes. Retrieved 2018-09-30.
  20. ↑ 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 2018-09-30.
  21. ↑ 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 2018-09-30.
  22. ↑ Commissioner, Office of the. "FDA Voices: Perspectives From FDA Experts". www.fda.gov. Retrieved 2018-09-30.
  23. ↑ Commissioner, Office of the. "Press Announcements - FDA approves first generic version of EpiPen". www.fda.gov. Retrieved 2018-09-30.
  24. 1 2 "Scott Gottlieb, MD - NEA - New Enterprise Associates". nea.com. Retrieved January 13, 2017.
  25. ↑ "Food and Drug Law Institute". National Health Council. Retrieved September 22, 2018.
  26. ↑ "Trump considering Dr. Scott Gottlieb to head FDA". December 12, 2016. Retrieved January 13, 2017 – via Reuters.
  27. ↑ "Ahead of Obamacare Repeal Rollout, Walker Stocks Up On Advisers Familiar With Capitol Hill", Roll Call.
  28. ↑ 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.
  29. 1 2 Adams, Ben, "Gottlieb confirmation as FDA commissioner warmly welcomed by biopharma", FierceBiotech, May 10, 2017. Retrieved May 10, 2017.
  30. ↑ Siegel, Dr. Marc, "A vote for Scott Gottlieb and medical discovery", Fox News, April 7, 2017. Retrieved May 10, 2017.
  31. ↑ "FDA nominee says nation's opioid crisis is as serious as Ebola, Zika threats". Washington Post. Retrieved July 15, 2017.
  32. ↑ Anna Edney (April 5, 2017). "Opioid Epidemic Is FDA's Top Priority, Says Pick to Head Agency". Bloomberg. Retrieved July 27, 2017.
  33. ↑ Karlin-Smith, Sarah, and Brent Griffiths, "Gottlieb confirmed as FDA chief", Politico, May 9, 2017. Retrieved May 10, 2017.
  34. ↑ Thomas, Katie (May 10, 2017). "Senate Confirms Scott Gottlieb to Head F.D.A." The New York Times. p. A13. Retrieved July 29, 2017.
  35. 1 2 Chon, Gina (July 28, 2017). "A Rare Victory for Science in an F.D.A. Move" – via NYTimes.com.
  36. ↑ 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.
  37. ↑ Board, Editorial (August 4, 2017). "The FDA just unveiled one of the most important public-health initiatives of the century". The Washington Post. Retrieved August 5, 2017.
  38. ↑ "FDA chief calls youth e-cigarettes an 'epidemic'". www.washingtonpost.com. Retrieved 2018-10-01.
  39. ↑ Anna Edney. "Drug Prices Become Target for FDA as Chief Expands Purview". Bloomberg. Retrieved July 27, 2017.
  40. ↑ Grant, Charley (May 25, 2017). "The Latest Drug Pricing Threat: The FDA" – via www.wsj.com.
  41. ↑ McGinley, Laurie. "FDA commissioner Gottlieb calls for 'more forceful steps' to curb opioid epidemic". The Washington Post. Retrieved July 27, 2017.
  42. ↑ "In its first big move under Gottlieb, FDA targets Endo International's Opana ER". BioWorld. Retrieved July 27, 2017.
  43. ↑ McGinley, Laurie (December 18, 2017). "FDA takes more aggressive stance toward homeopathic drugs". Retrieved December 26, 2017 – via www.WashingtonPost.com.
  44. ↑ Fortune Magazine, April 19, 2018
  45. ↑ Medicine, Society of Hospital. "Public Policy Committee - Society of Hospital Medicine". hospitalmedicine.org. Retrieved January 13, 2017.
  46. ↑ "Board of Directors". toleropharma.com. Retrieved January 13, 2017.
  47. ↑ "Company Daiichi Sankyo, Inc". us-companies.info. Retrieved January 13, 2017.
  48. ↑ "Scott Gottieb's LinkIn profile". Retrieved 7 February 2018.
  49. ↑ "Scott Gottlieb {first-person bio}", forbes.com. Retrieved March 10, 2017.
  50. ↑ "Emeritus Advisory Board". Retrieved March 10, 2017.
  51. ↑ "11 Numbers to Know About Scott Gottlieb". U.S. News & World Report. Kaiser Health News. March 14, 2017. Retrieved May 3, 2017.
  52. ↑ Gottlieb, Scott. "Scott Gottlieb - Medical Innovation". forbes.com. Retrieved January 13, 2017.
  53. ↑ Gottlieb, Scott (May 12, 2009). "How ObamaCare Will Affect Your Doctor". Retrieved December 26, 2017 – via www.WSJ.com.
  54. ↑ Astrue, Scott Gottlieb And Michael. "Gottlieb and Astrue: ObamaCare's Technology Mess". WSJ.com. Retrieved December 26, 2017.
  55. ↑ "Medicaid is worse than no coverage at all".
  56. ↑ Medicaid Worsens Your Health? That’s a Classic Misinterpretation of Research, By AARON E. CARROLL and AUSTIN FRAKT, JULY 3, 2017
  57. ↑ 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
  58. ↑ Are Medicaid patients more likely to die than uninsured, as Heritage Action CEO says? By Amy Sherman, Politifact, June 28, 2017
  59. ↑ Gottlieb, Scott (August 29, 2016). "Former FDA official explains why drug makers charge outrageous prices". cnbc.com. Retrieved January 13, 2017.
  60. ↑ "Dr. Scott Gottlieb". foxnews.com. January 13, 2017. Retrieved January 13, 2017.
Political offices
Preceded by
Robert Califf		 Commissioner of Food and Drugs
2017–present		 Incumbent
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