Scott Gottlieb

This article is about the American physician. For the drummer, see Scott Gottlieb (musician).

Scott Gottlieb
File:Scott Gottlieb official portrait.jpg
Commissioner of Food and Drugs
Incumbent
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 and investor who serves as commissioner of the Food and Drug Administration (FDA). 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, the FDA Deputy Commissioner for Medical and Scientific Affairs, an investing partner at the venture capital firm New Enterprise Associates, and a member of the policy board of the Leukemia and Lymphoma Society.

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 was married in a Jewish wedding ceremony.

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. 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. 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. 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.

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. 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. 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, healthcare reform, and medical innovation. 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 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 equivalents 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, with the difference being split among various players along the pharmaceutical supply chain but not benefiting patients who are sometimes forced to pa the full list price. 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 obtain FDA approval for generic equivalents of 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". 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 generic, functionally equivalent alternatives to EpiPen. The agency recently approved the first generic version of EpiPen. 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.

FDA Commissioner (2017 - Present)

File:Commissioner Gottlieb at the National Press Club (37511745444).jpg

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. 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. In early March 2017, news of the nomination plan emerged. 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, New Enterprise, TR Winston, MedAvante and Glytec. The nominee testified before Committee on Health, Education, Labor and Pensions (HELP). There, Gottlieb equated the spread of opioid addiction with the previous epidemics of Ebola and Zika virus. 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. On May 9, 2017, Gottlieb was confirmed by the Senate by a vote of 57–42.

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", causing shares of tobacco company Altria that day to initially decline by 19%. 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." 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." 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. 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." After the ban was announced, the Washington Post commented in an editorial “In fact, the 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.” The Washington Post noted that in addition to a proposed ban on menthol in cigarettes and flavors in cigars, declaring, “I will not allow a generation of children to become addicted to nicotine through e-cigarettes,” FDA Commissioner Scott Gottlieb announced “most flavored e-cigarette liquids would be banned from stores unless they have stringent age-verification measures in place. Fruity and creamy flavors that appeal to children will disappear from open convenience store shelves. Users will have to enter specialized vaping shops or tobacco stores to get flavors other than mint, menthol and tobacco. Other stores can sell additional flavors but only if they have separate, age-controlled rooms dedicated to their sale. Web sales, too, will require more extensive age-checking measures.”

As FDA Commissioner, Gottlieb has also advanced initiatives on addressing drug pricing "in ways that the agency hasn't done before" according to the Wall Street Journal. He committed to make fighting the crisis of opioid addiction one of his highest priorities as Commissioner. 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." 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." In May 2018 Gottlieb launched a major crack down on allegedly rogue stem cell clinics, asking 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 in the new space while also helping to advance development of effective products. 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. 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." 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. Last year, he pulled an opioid off the market because its addictive properties outweighed its painkilling benefits, and this year he addressed high drug prices by approving more generic versions and cracked down on e-cigarette makers and questionable stem-cell clinics." In naming Gottlieb as one of its "50 Politicos for 2018" the publication Politico noted that "The Food and Drug Administration commissioner wants to regulate tobacco, crack down on rogue stem cell clinics and strictly limit the salt in your food. He has gone after powerful pharmaceutical companies when they don’t play by the rules and has kept in place Obama-era requirements for calorie counts and Nutrition Facts... 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."

Other Professional Activities

Gottlieb was a member of the Public Policy Committee to the Society of Hospital Medicine and was an adviser to the National Coalition for Cancer Survivorship. He has been a venture partner at New Enterprise Associates since 2007 and was an independent director at Tolero Pharmaceuticals and Daiichi Sankyo Inc. and a member of GlaxoSmithKline's product investment board. 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. 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. He has served as an advisor to Cancer Commons.

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. He is a regular contributor to the editorial page of the Wall Street Journal and writes regularly for Forbes. In his various writings, Gottlieb was a frequent and early critic of the 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 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. 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". Gottlieb also appears regularly on CNBC and Fox News.

Personal life

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

External links

• Biography at FDA
• Appearances on C-SPAN
• Scott Gottlieb on Twitter

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