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Wikipedia

Scott Gottlieb

Scott Gottlieb (born June 11, 1972) is an American physician and investor 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),[1][2] a member of the board of directors of drug maker Pfizer, Inc,[3] a member of the board of directors of Illumina, Inc.,[4] a contributor to the cable financial news network CNBC, and a frequent guest on the CBS News program Face the Nation.[5] An elected member of the National Academy of Medicine, Gottlieb is the author of The New York Times best selling book Uncontrolled Spread[6] on the COVID-19 pandemic and the national security vulnerabilities that it revealed.

Scott Gottlieb
Gottlieb in 2017
23rd Commissioner of Food and Drugs
In office
May 11, 2017 – April 5, 2019
PresidentDonald Trump
DeputyAnna Abram
Preceded byRobert Califf
Succeeded byNorman Sharpless
Personal details
Born (1972-06-11) June 11, 1972 (age 51)
East Brunswick, New Jersey, U.S.
Political partyRepublican
EducationWesleyan University (BA)
Mount Sinai Medical Center
(MD)

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 NEA, 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 Edit

Gottlieb grew up in East Brunswick, New Jersey, the son of Stanley, who was a psychiatrist, and Marsha Gottlieb.[7] 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.[8] He is Jewish.[9]

Career Edit

FDA and CMS (2003–2007) Edit

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]

Private sector (2007–2017) Edit

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]

FDA commissioner (2017–2019) Edit

 
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]

Private sector (2019–present) Edit

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]

Other professional activities Edit

Gottlieb was a member of the Public Policy Committee to the Society of Hospital Medicine[110] 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, and Cancer Commons.[111][112] Before first joining the FDA, and in between each of his three tours of government service, Gottlieb was a resident fellow at the American Enterprise Institute.[13]

Writing Edit

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.[113] He is a regular contributor to the editorial page of The Wall Street Journal and The Washington Post and wrote regularly for Forbes.[114] Gottlieb was a frequent and early critic of the Patient Protection and Affordable Care Act.[115] 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.[116] 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.[117] Critics said that his article was based on "a classic misunderstanding: confusing correlation for causation," a limitation explicitly mentioned in papers he cited.[118][119][120]

In October 2019, Gottlieb wrote a feature for the conservative editorial page of The Wall Street Journal, where he called for a "reckoning" when it comes to the impasse between state laws legalizing cannabis and the policy of federal prohibition that outlaws cannabis but is largely unenforced. In that op-ed, Gottlieb called for a pathway toward federal legalization of cannabis that would allow, among other reforms, easier access to the compound for research while exerting stricter and more uniform regulation over products.[121][122] In a separate editorial writing in The Washington Post, Gottlieb called on Congress and the FDA to create a framework for the legal sale of regulated CBD.[123]

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.[124] On January 27, Gottlieb wrote an Op-Ed titled "We need to prepare for US outbreak of Wuhan coronavirus."[125] 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."[126]

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.[127] 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.[128][129] 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.[130]

Recognition Edit

  • 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."[131] Fortune magazine selected Gottlieb again in its 2019 survey, ranking him number 50 among its "World's 50 Greatest Leaders."[132]
  • Time magazine named Gottlieb one of its "50 People Transforming Healthcare in 2018,"[133] 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."[134]
  • 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."[135] 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."[136]
  • Modern Healthcare also named Gottlieb nineteenth in its survey of the 100 most influential people in healthcare, in 2018,[137] fifty-fifth in 2019, and fifty-fourth in 2021.[138][139]
  • In October 2018, Gottlieb was elected a member of the National Academy of Medicine.[140]
  • The American Medical Association presented Gottlieb with its 2019 Dr. Nathan Davis Award for Outstanding Government Service.[141]
  • In May 2019, Gottlieb received an honorary Doctor of Science degree from the Icahn School of Medicine at Mount Sinai for "his commitment to improving the nation's health and for his work at the FDA, expediting the approval of treatments and drugs, and battling opioid addiction and the use of e-cigarettes by youth."[142]
  • 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.[143]
  • 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."[144]
  • 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."[145]
  • Gottlieb was named one of "Washington's 2021 Most Influential People" by Washingtonian.[146]
  • In May 2021, Gottlieb received an honorary Doctor of Science degree from Wesleyan University in recognition of "his achievements in dealing with the opioid crisis, the epidemic use of electronic cigarettes, and drug pricing, as well as his willingness to speak up and educate others on the nature of the COVID-19 virus."[147]
  • Gottlieb was recognized by Modern Healthcare as one of 2021's 100 Most Influential People in Healthcare.[148]
  • 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."[149]
  • Gottlieb was named one of Washington, D.C.'s 500 Most Influential People Shaping Policy in 2022 and 2023 by Washingtonian.[150] [151]
  • 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."[152]

Personal life Edit

Gottlieb is a survivor of Hodgkin lymphoma.[153] He is married and has three daughters.[7]

References Edit

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External links Edit

  • Biography at FDA
  • Appearances on C-SPAN
  • Scott Gottlieb on Twitter
  • Homepage at AEI
  • Web Page at NEA
  • CNBC Contributor
Political offices
Preceded by 23rd Commissioner of Food and Drugs
2017–2019
Succeeded by

scott, gottlieb, this, article, about, american, physician, drummer, musician, born, june, 1972, american, physician, investor, served, 23rd, commissioner, food, drug, administration, from, 2017, until, april, 2019, presently, senior, fellow, conservative, thi. This article is about the American physician For the drummer see Scott Gottlieb musician Scott Gottlieb born June 11 1972 is an American physician and investor 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 1 2 a member of the board of directors of drug maker Pfizer Inc 3 a member of the board of directors of Illumina Inc 4 a contributor to the cable financial news network CNBC and a frequent guest on the CBS News program Face the Nation 5 An elected member of the National Academy of Medicine Gottlieb is the author of The New York Times best selling book Uncontrolled Spread 6 on the COVID 19 pandemic and the national security vulnerabilities that it revealed Scott GottliebGottlieb in 201723rd Commissioner of Food and DrugsIn office May 11 2017 April 5 2019PresidentDonald TrumpDeputyAnna AbramPreceded byRobert CaliffSucceeded byNorman SharplessPersonal detailsBorn 1972 06 11 June 11 1972 age 51 East Brunswick New Jersey U S Political partyRepublicanEducationWesleyan University BA Mount Sinai Medical Center MD 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 NEA a member of the policy board of the Leukemia amp Lymphoma Society a senior official at the Centers for Medicare amp 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 Contents 1 Early life and education 2 Career 2 1 FDA and CMS 2003 2007 2 2 Private sector 2007 2017 2 3 FDA commissioner 2017 2019 2 4 Private sector 2019 present 3 Other professional activities 4 Writing 5 Recognition 6 Personal life 7 References 8 External linksEarly life and education EditGottlieb grew up in East Brunswick New Jersey the son of Stanley who was a psychiatrist and Marsha Gottlieb 7 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 amp 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 8 He is Jewish 9 Career EditFDA and CMS 2003 2007 Edit 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 amp 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 Private sector 2007 2017 Edit 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 FDA commissioner 2017 2019 Edit Gottlieb speaks at the National Press Club in 2017Starting 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 Private sector 2019 present Edit 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 Other professional activities EditGottlieb was a member of the Public Policy Committee to the Society of Hospital Medicine 110 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 and Cancer Commons 111 112 Before first joining the FDA and in between each of his three tours of government service Gottlieb was a resident fellow at the American Enterprise Institute 13 Writing EditGottlieb 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 113 He is a regular contributor to the editorial page of The Wall Street Journal and The Washington Post and wrote regularly for Forbes 114 Gottlieb was a frequent and early critic of the Patient Protection and Affordable Care Act 115 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 116 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 117 Critics said that his article was based on a classic misunderstanding confusing correlation for causation a limitation explicitly mentioned in papers he cited 118 119 120 In October 2019 Gottlieb wrote a feature for the conservative editorial page of The Wall Street Journal where he called for a reckoning when it comes to the impasse between state laws legalizing cannabis and the policy of federal prohibition that outlaws cannabis but is largely unenforced In that op ed Gottlieb called for a pathway toward federal legalization of cannabis that would allow among other reforms easier access to the compound for research while exerting stricter and more uniform regulation over products 121 122 In a separate editorial writing in The Washington Post Gottlieb called on Congress and the FDA to create a framework for the legal sale of regulated CBD 123 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 124 On January 27 Gottlieb wrote an Op Ed titled We need to prepare for US outbreak of Wuhan coronavirus 125 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 126 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 127 Uncontrolled Spread debuted at No 5 on The New York Times Best Seller list for Hardcover Nonfiction and at No 6 for Combined Print amp E Book Nonfiction 128 129 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 130 Recognition EditFortune 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 131 Fortune magazine selected Gottlieb again in its 2019 survey ranking him number 50 among its World s 50 Greatest Leaders 132 Time magazine named Gottlieb one of its 50 People Transforming Healthcare in 2018 133 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 134 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 135 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 136 Modern Healthcare also named Gottlieb nineteenth in its survey of the 100 most influential people in healthcare in 2018 137 fifty fifth in 2019 and fifty fourth in 2021 138 139 In October 2018 Gottlieb was elected a member of the National Academy of Medicine 140 The American Medical Association presented Gottlieb with its 2019 Dr Nathan Davis Award for Outstanding Government Service 141 In May 2019 Gottlieb received an honorary Doctor of Science degree from the Icahn School of Medicine at Mount Sinai for his commitment to improving the nation s health and for his work at the FDA expediting the approval of treatments and drugs and battling opioid addiction and the use of e cigarettes by youth 142 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 143 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 144 Medical Marketing amp Media MM amp 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 145 Gottlieb was named one of Washington s 2021 Most Influential People by Washingtonian 146 In May 2021 Gottlieb received an honorary Doctor of Science degree from Wesleyan University in recognition of his achievements in dealing with the opioid crisis the epidemic use of electronic cigarettes and drug pricing as well as his willingness to speak up and educate others on the nature of the COVID 19 virus 147 Gottlieb was recognized by Modern Healthcare as one of 2021 s 100 Most Influential People in Healthcare 148 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 149 Gottlieb was named one of Washington D C s 500 Most Influential People Shaping Policy in 2022 and 2023 by Washingtonian 150 151 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 152 Personal life EditGottlieb is a survivor of Hodgkin lymphoma 153 He is married and has three daughters 7 References Edit a b Former FDA Commissioner Gottlieb Returns to NEA as Venture Investor The Wall Street Journal Retrieved June 2 2019 a b New Enterprise Associates Inc May 22 2019 NEA Welcomes Scott Gottlieb M D As Special Partner PR Newswire Press release Chevy Chase MD Cision Retrieved January 17 2023 Ex FDA chief Scott Gottlieb just joined the board of 240 billion drugmaker Pfizer Business Insider Retrieved July 5 2019 a b Dr Scott Gottlieb former US FDA Commissioner joins Illumina s Board of Directors investor illumina com Retrieved February 26 2021 How a Coronavirus Expert Shook Up CBS Face the Nation Variety Retrieved August 10 2021 Ward Myah June 4 2021 Here come the pandemic memoirs POLITICO Retrieved August 26 2021 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 Allyson Nemeroff Scott Gottlieb The New York Times June 13 2004 Retrieved January 13 2017 FDA head Scott Gottlieb a vaping opponent stepping down after 2 years The JEWISH TELEGRAPHIC AGENCY March 7 2019 Retrieved June 28 2019 Meet Scott Gottlieb M D Commissioner of Food and Drugs FDA Retrieved October 29 2018 a b Dr Scott Gottlieb intelligencesquaredus org March 1 2016 Retrieved January 13 2017 Q amp A with Scott Gottlieb MD Managed Care magazine March 10 2017 Retrieved April 1 2019 a b Scott Gottlieb American Enterprise Institute Retrieved September 10 2016 Morrow Brendan March 10 2017 Scott Gottlieb 5 Fast Facts You Need to Know Heavy Retrieved May 3 2017 Scott Gottlieb M D Bloomberg Retrieved March 7 2019 NEA Venture Partner Scott Gottlieb M D Nominated to be FDA Commissioner nea com March 11 2017 Retrieved September 22 2018 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 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 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 Board of Directors toleropharma com Retrieved January 13 2017 Company Daiichi Sankyo Inc us companies info Retrieved January 13 2017 Scott Gottieb s LinkIn profile Retrieved February 7 2018 Scott Gottlieb first person bio forbes com Retrieved March 10 2017 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 Scott Gottlieb MD NEA New Enterprise Associates nea com Archived from the original on November 21 2016 Retrieved January 13 2017 Food and Drug Law Institute National Health Council Retrieved September 22 2018 Ahead of Obamacare Repeal Rollout Walker Stocks Up On Advisers Familiar With Capitol Hill Roll Call Neel Joe March 10 2017 Trump Chooses Dr Scott Gottlieb To Head Food And Drug Administration NPR Retrieved March 10 2017 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 Cunningham Paige Winfield March 10 2017 Trump expected to pick Scott Gottlieb to head FDA Washington Examiner Retrieved March 10 2017 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 a b Adams Ben Gottlieb confirmation as FDA commissioner warmly welcomed by biopharma FierceBiotech May 10 2017 Retrieved May 10 2017 Karlin Smith Sarah and Brent Griffiths Gottlieb confirmed as FDA chief Politico May 9 2017 Retrieved May 10 2017 Siegel Marc April 7 2017 A vote for Scott Gottlieb and medical discovery Fox News Retrieved May 10 2017 FDA nominee says nation s opioid crisis is as serious as Ebola Zika threats Washington Post Retrieved July 15 2017 Edney Anna April 5 2017 Opioid Epidemic Is FDA s Top Priority Says Pick to Head Agency Bloomberg Retrieved July 27 2017 Thomas Katie May 10 2017 Senate Confirms Scott Gottlieb to Head F D A The New York Times p A13 Retrieved July 29 2017 O Donnell Jayne March 5 2019 FDA surprise Commissioner Scott Gottlieb aggressive regulator against vaping resigns USA Today p A13 Retrieved April 30 2019 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 Dr Gottlieb s Final Address to FDA FDA April 4 2019 FDA requests removal of Opana ER for risks related to abuse FDA June 8 2017 FDA Seems Removal of Opioid Painkiller from the Market The Washington Post June 8 2017 Chon Gina July 28 2017 A Rare Victory for Science in an F D A Move The New York Times 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 Commissioner Office of the November 3 2018 FDA approval brings first gene therapy to the United States FDA Retrieved November 22 2019 McGinley Laurie December 18 2017 FDA takes more aggressive stance toward homeopathic drugs Retrieved December 26 2017 via www WashingtonPost com FDA seeks to limit the addictive properties of cigarettes NBC News March 16 2018 McGinley Laurie March 15 2018 FDA takes historic step to lower nicotine in cigarettes chicagotribune com Winfield Paige March 16 2018 The Health 202 Who knew A top Trump conservative is aggressively taking on tobacco The Washington Post Retrieved April 5 2019 Cigarette nicotine levels could lower after FDA move making them less addictive USA TODAY Kaplan Sheila Grady Denise August 28 2017 F D A Cracks Down on Unscrupulous Stem Cell Clinics The New York Times ISSN 0362 4331 Retrieved February 21 2023 Wan William May 9 2018 FDA Seeks Injunction To Stop Two Stem Cell Companies After Patients Blinded The Washington Post Retrieved March 5 2019 Gottlieb Marks Detail Plans to Advance Development of Cell and Gene Therapies www raps org Retrieved February 21 2023 FDA chief calls youth e cigarettes an epidemic Washington Post Retrieved October 1 2018 FDA plans curbs on e cigarette sales over concerns about surge in teen vaping Washington Post Retrieved November 12 2018 Editorial Board November 17 2019 The FDA s New Tobacco Rules are a Victory for Public Health The Washington Post Retrieved January 17 2023 Kaplan Sheila January 4 2019 F D A Accuses Juul and Altria of Backing Off Plan to Stop Youth Vaping The New York Times ISSN 0362 4331 Retrieved October 28 2019 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 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 Commissioner Office of the FDA Voices Perspectives From FDA Experts www fda gov Retrieved September 30 2018 Commissioner Office of the Press Announcements FDA approves first generic version of EpiPen www fda gov Retrieved September 30 2018 Commissioner Office of the 2018 A year of Advancing Generic Products and Policies Laying the Foundation for 2019 www fda gov Retrieved April 28 2019 FDA and DoD formalize collaboration to advance medical products in support of American military personnel FDA Retrieved April 3 2019 FDA chief Keep defense medical approvals in our sphere The Hill November 7 2017 Retrieved April 3 2019 GOP senators say they ll oppose defense bill if Pentagon drug policy stays in Politico November 7 2017 Retrieved April 3 2019 FDA and Pentagon in Turf War over Product Approvals Washington Examiner November 7 2017 Controversy erupts over plan to let Pentagon authorize unapproved drugs for battlefield use The Washington Post Edney Anna June 5 2017 Drug Prices Become Target for FDA as Chief Expands Purview Bloomberg com Bloomberg Retrieved July 27 2017 Grant Charley May 25 2017 The Latest Drug Pricing Threat The FDA The Wall Street Journal Statement from FDA Commissioner Scott Gottlieb M D on new actions advancing the agency s biosimilars policy framework Food and Drug Administration March 24 2020 McGinley Laurie FDA commissioner Gottlieb calls for more forceful steps to curb opioid epidemic The Washington Post Retrieved July 27 2017 Statement from FDA Commissioner Scott Gottlieb M D on agency s approval of Dsuvia and the FDA s future consideration of new opioids Food and Drug Administration March 24 2020 Burton Tom March 28 2019 FDA Commissioner Calls for Tighter Standard for Approval of New Opioid Drugs The Wall Street Journal In its first big move under Gottlieb FDA targets Endo International s Opana ER BioWorld Retrieved July 27 2017 Bursztynsky Jessica February 11 2019 FDA plans to strengthen oversight of dietary supplements market www cnbc com Retrieved February 19 2019 FDA developing new rules for artificial intelligence in medicine STAT April 2 2019 Retrieved March 11 2022 Commissioner Office of the March 24 2020 Statement from FDA Commissioner Scott Gottlieb M D on steps toward a new tailored review framework for artificial intelligence based medical devices FDA Retrieved March 11 2022 Statement from Congressman Frank Pallone March 5 2019 Retrieved March 7 2019 McGinley Laurie Bernstein Lenny March 5 2019 FDA Commissioner Gottlieb who raised alarms about teen vaping resigns Washington Post Retrieved March 5 2019 Popular FDA commish Scott Gottlieb has handed in his resignation Endpoints News Retrieved January 16 2020 Kaplan Sheila Hoffman Jan March 5 2019 F D A Commissioner Scott Gottlieb Who Fought Teenage Vaping Resigns The New York Times ISSN 0362 4331 Retrieved January 16 2020 Something very rare FDA s Gottlieb aggressively tackled difficult issues Politico March 5 2019 Retrieved April 3 2019 FDA Commissioner Scott Gottlieb to step down Politico March 5 2019 Retrieved May 5 2019 Kaplan Sheila Hoffman Jan March 5 2019 F D A Commissioner Scott Gottlieb Who Fought Teenage Vaping Resigns New York Times Retrieved May 5 2019 Kaplan Sheila March 13 2019 F D A Moves to Restrict Flavored E Cigarette Sales to Teenagers The New York Times Retrieved March 13 2019 Commissioner Office of the March 24 2020 Press Announcements FDA advances landmark policy changes to modernize mammography services and improve their quality www fda gov Grady Denise March 27 2019 Mammogram Centers Must Tell Women if They Have Dense Breasts F D A Proposes The New York Times FDA chief wants more mail inspectors to stem opioid influx STAT March 6 2018 Retrieved October 12 2022 FDA Announces Import Staffing Change at International Mail Facilities Akin Gump Strauss Hauer amp Feld LLP Retrieved October 12 2022 Commissioner Office of the March 24 2020 FDA and CBP bolster collaboration to protect public health and safety FDA Retrieved October 12 2022 FDA Seeks Changes to Authorities at International Mail Facilities www raps org Retrieved October 12 2022 Hellmann Jessie April 4 2019 Departing FDA chief to work at conservative think tank The Hill Retrieved April 4 2019 Leonard Kimberly April 4 2019 FDA s Scott Gottlieb returning to conservative think tank Washington Examiner Retrieved April 4 2019 Tempus Announces the Appointment of Scott Gottlieb MD to Its Board of Directors BioSpace Retrieved October 30 2019 Pfizer Names Former FDA Chief Gottlieb to Board of Directors Bloomberg Retrieved June 30 2019 Scott Gottlieb Elected to Pfizer s Board of Directors Pfizer www pfizer com Retrieved October 11 2019 Resilience a well funded manufacturing startup joins with the Parker Institute to make cancer drugs BioPharma Dive Retrieved April 15 2023 RESILIENCE Launches to Change the Future of Medicine through Manufacturing Innovation prnewswire com Press release Retrieved November 23 2020 One Year Later Icahn School of Medicine at Mount Sinai Says Thank You To Residents Who Joined Front Line Workers During Pandemic Peak health mountsinai org March 3 2021 Retrieved March 3 2021 Wesleyan University Board of Trustees 2021 2022 wesleyan edu Retrieved October 16 2021 Owermohle Sarah and Diamond Dan The shadow coronavirus czar Politico March 15 2020 Former FDA Commissioner Scott Gottlieb on the Fight Against COVID 19 TIME Retrieved April 9 2020 Former FDA Commissioner Scott Gottlieb offers plans for beating back coronavirus The Washington Post Retrieved April 14 2020 Testimony Are we prepared Protecting the US from global pandemics AEI Retrieved February 12 2020 ROUNDTABLE Are We Prepared Protecting the U S from Global Pandemics hsgac senate gov Retrieved February 12 2020 National coronavirus response A road map to reopening AEI Retrieved March 29 2020 Sherman Jake Palmer Anna April 7 2020 POLITICO Playbook Scoop Trump s shadow coronavirus czar will now advise Larry Hogan POLITICO Retrieved April 7 2020 Governor Lamont Announces Creation of Group of Health and Business Experts Who Will Provide Advice and Recommendations on the Reopening of Connecticut s Economy portal ct gov Retrieved April 13 2020 Former FDA head named to Montana COVID 19 panel greatfallstribune Retrieved November 20 2020 Medicine Society of Hospital Public Policy Committee Society of Hospital Medicine hospitalmedicine org Retrieved January 13 2017 Scott Gottlieb Bio 2016 House Testimony PDF docs house gov Retrieved May 11 2016 Emeritus Advisory Board Retrieved March 10 2017 11 Numbers to Know About Scott Gottlieb U S News amp World Report Kaiser Health News March 14 2017 Retrieved May 3 2017 Gottlieb Scott Scott Gottlieb Medical Innovation forbes com Retrieved January 13 2017 Gottlieb Scott May 12 2009 How ObamaCare Will Affect Your Doctor Wall Street Journal Retrieved December 26 2017 via www WSJ com Astrue Scott Gottlieb And Michael September 30 2013 Gottlieb and Astrue ObamaCare s Technology Mess Wall Street Journal Retrieved December 26 2017 Medicaid is worse than no coverage at all Medicaid Worsens Your Health That s a Classic Misinterpretation of Research By AARON E CARROLL and AUSTIN FRAKT July 3 2017 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 Are Medicaid patients more likely to die than uninsured as Heritage Action CEO says By Amy Sherman Politifact June 28 2017 Gottlieb Scott October 10 2019 Opinion Pot Legalization Makes Vaping Deadly Wall Street Journal Retrieved October 29 2019 Owermohle Sarah September 19 2019 Former FDA commissioner says feds need to regulate marijuana POLITICO Retrieved October 29 2019 Gottlieb Scott Opinion The CBD craze is getting out of hand The FDA needs to act Washington Post Retrieved October 30 2019 What must be done to head off the coronavirus threat Washington Post Retrieved January 23 2020 We need to prepare for US outbreak of Wuhan coronavirus CNBC January 27 2020 Retrieved January 27 2020 Act Now to Prevent an American Epidemic The Wall Street Journal January 28 2020 Retrieved January 28 2020 Former FDA commissioner We remain almost equally vulnerable to threat from the next pandemic washingtonpost Retrieved September 14 2021 Hardcover Nonfiction Best Sellers The New York Times The New York Times Retrieved September 29 2021 Combined Print amp E Book Nonfiction Best Sellers The New York Times The New York Times Retrieved September 29 2021 Publishers Weekly Bestseller Lists PublishersWeekly com Retrieved October 4 2021 The World s 50 Greatest Leaders Fortune Magazine Retrieved April 19 2018 The World s 50 Greatest Leaders Fortune Magazine Retrieved April 22 2019 Why Dr Scott Gottlieb Is One of the 50 Most Influential People in Health Care Time Retrieved January 21 2019 Scott Gottlieb POLITICO 50 2018 POLITICO Retrieved September 4 2018 Gottlieb sets a new standard for FDA commissioner Modern Healthcare June 14 2018 Retrieved January 21 2019 Gottlieb s legacy could be felt for years Modern Healthcare June 12 2019 Retrieved June 15 2019 100 Most Influential People in Healthcare 2018 Modern Healthcare February 14 2019 Retrieved August 18 2019 100 Most Influential People in Healthcare 2019 Modern Healthcare February 6 2019 Retrieved December 30 2019 100 Most Influential People in Healthcare 2021 Modern Healthcare December 6 2021 Retrieved December 28 2021 National Academy of Medicine Elects 85 New Members nationalacademies org Retrieved October 15 2018 Scott Gottlieb Nathan Davis Award for Government Service ama assn org February 13 2019 At 50th Commencement a Call to Engage in Health Issues health mountsinai org June 24 2019 23rd Annual Cancer Leadership Awards Reception friendsofcancerresearch org September 25 2019 50 Most Influential Clinical Executives 2020 Modern Healthcare June 4 2020 Retrieved June 15 2020 Health Influencer 50 2020 Medical Marketing amp Media and PRWeek October 26 2020 Retrieved October 26 2020 Washington s Most Influential People Washingtonian Retrieved February 26 2020 Betts Flowers Gottlieb 94 Receive Honorary Degrees newsletter blogs wesleyan edu May 26 2021 100 Most Influential People in Healthcare 2021 Modern Healthcare December 9 2021 Retrieved December 18 2021 Mediaite s Most Influential in News Media 2021 Mediaite December 21 2021 Retrieved December 21 2021 Washington DC s 500 Most Influential People Washingtonian May 3 2022 Retrieved May 3 2022 Washington DC s 500 Most Influential People of 2023 April 27 2023 Retrieved July 25 2023 Sagonowsky Eric October 26 2020 The 22 most influential people in the fight against COVID 19 Fierce Pharma Retrieved May 23 2022 LaMotte Sandee April 4 2017 Scott Gottlieb Conflicts surround Trump s FDA pick CNN Retrieved May 3 2017 External links Edit Wikimedia Commons has media related to Scott Gottlieb Biography at FDA Appearances on C SPAN Scott Gottlieb on Twitter Homepage at AEI Web Page at NEA CNBC ContributorPolitical officesPreceded byRobert Califf 23rd Commissioner of Food and Drugs2017 2019 Succeeded byNorman SharplessActing Retrieved from https en wikipedia org w index php title Scott Gottlieb amp oldid 1167065259, wikipedia, wiki, book, books, library,

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