Scott Gottlieb

Gottlieb worked for the U.S. Food and Drug Administration (FDA) from 2002 to 2003 and 2005 to 2007.[10] 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.[11] 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.[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. 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.[14]

Gottlieb practiced internal medicine as an attending physician at New York University's Tisch Hospital in New York City.[15]

In 2007, Gottlieb became a venture partner at New Enterprise Associates (NEA), the world's largest venture capital firm by assets under management.[16] 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,[17] healthcare reform[18] and medical innovation.[19] 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."[17]

He was an independent director at Tolero Pharmaceuticals[20] and Daiichi Sankyo Inc.[21] and a member of GlaxoSmithKline's product investment board, which made decisions on which drugs GSK would take forward in development.[22] 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.[23] In 2015, he served on the Board of Directors of Kure Corp, a provider of vaping products.[24] 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.[11][25][26]

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.[27]

He was nominated as FDA Commissioner in March 2017.[28][29][30] 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,[31] and New Enterprise Associates.[32] 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] He testified before the Senate Committee on Health, Education, Labor and Pensions.[34] There, Gottlieb equated the spread of opioid addiction with earlier epidemics of Ebola and Zika.[35][36] 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." On May 9, 2017, he was confirmed by the Senate[32] by a vote of 57–42,[37] and he was sworn in on May 11, 2017.[38]

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.[39] While Commissioner, Gottlieb testified before Congress 19 times.[40]

On June 8, 2017, Gottlieb requested[41] 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.[42]

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,"[43] causing shares of tobacco company Altria that day to initially decline by 19%.[44]

Gottlieb approved the first gene therapy product in the U.S. on August 30, 2017.[45]

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.[46]

In March 2018, the FDA, under Gottlieb, initiated a rule to lower the amount of nicotine in cigarettes to make them less addictive—in "an unprecedented move by the agency… It's the boldest move yet against cigarette makers by the FDA, which only obtained permission to regulate tobacco products in 2009."[47][48][49][50]

In August 2017, Gottlieb announced an initiative to accelerate the development of cell based therapies while also taking actions to crack down on what he called "unscrupulous" actors who were marketing unregulated stem cell therapy products that had caused some patients harm. Many of the companies that the FDA cited had been performing liposuction to remove fat from patients, isolating stem cells and then injecting those cells back into the same patients to treat various ailments.[51] 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.[52]

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.[53]

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.[54] 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.[55] 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."[56] That policy was formally unveiled in March 2019. 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.[57]

Gottlieb pursued policies to address barriers to the approval of complex generic drugs, including generic, functionally equivalent alternatives to EpiPen.[58][59][60] Under his leadership, in August 2018, the FDA approved the first generic competitor of EpiPen,[61] 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."[62]

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.[63] 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.[64][65] The episode exposed an unusual "turf war" that pitted Gottlieb and the FDA against Pentagon officials[66] and "puts on public display an internal rift within the administration and in Republican congressional ranks."[67]

Gottlieb advanced initiatives on addressing drug pricing,[68] "in ways that the agency hasn't done before."[69] 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.[70]

He also committed to make fighting opioid addiction one of his highest priorities as Commissioner.[71] He announced that the FDA would pursue a comparative approval standard[72] for new opioids seeking to come to market, arguing that new opioid painkillers should show advantages over existing opioid drugs to win FDA approval. 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.[73] 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."[74]

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.[75]

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.[76][77]

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.[78]

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.[79][80][81] 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, while garnering criticism from several of the targeted businesses like tobacco companies and the fast-growing e-cigarette industries."[82]

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."[83] 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.[84]

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.[85] Under the policy, the FDA would reserve the right to push companies to comply or remove their products from shelves.

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.[86][87]

While commissioner, Gottlieb undertook a substantial expansion of the FDA's interdiction activities inside the international mail facilities, to expand the agency's ability to intercept opioids being shipped through the mail from places like China. 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.[88] The FDA also launched a new collaboration with Customs and Border Protection to step up joint inspectional activities.[89][90][91]

Upon leaving the FDA, Gottlieb returned to the American Enterprise Institute.[92][93] In May 2019, he returned to New Enterprise Associates as a partner in the firm's healthcare practice, and serves on the board of two NEA portfolio companies, Aetion, Inc. and Tempus Labs, Inc.[1][2][94] Gottlieb was elected as an independent member of the board of directors of Pfizer, Inc. in June 2019.[95][96] He joined the Illumina, Inc. board of directors in February 2020[4] and the National Resilience, Inc. board of directors in November 2020, where he was one of the original venture investors.[97][98] He is also a member of the boards of trustees of the Mount Sinai Health System[99] and Wesleyan University.[100]

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.[101][102][103] 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.[104][105] 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.[106] 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.[107] He has also advised Connecticut Governor Ned Lamont as a member of the Reopen Connecticut Advisory Group.[108] On November 20, 2020, it was announced that Gottlieb would serve on Montana's Governor-elect Greg Gianforte's COVID-19 task force.[109]