UPDATE: Scott Gottlieb Resigns From Role as FDA Commissioner

Headshot of Scott Gottlieb

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Scott Gottlieb, the proactive commissioner of the U.S. Food and Drug Administration (FDA) who oversaw a record number of drug approvals has resigned.

According to the Washington Post, which was the first to report the news, Gottlieb will leave the regulatory agency in about a month. Gottlieb intends to spend more time with his family, the Post said. At 46, he is the father of three children, nine-year-old twins and a five-year-old. He commutes weekly from Connecticut, the Post said.In his letter of resignation, which was shared on Twitter late Tuesday, Gottlieb said he loved the mission of the FDA, but said the challenge of being away from his wife and children was too much.

Since taking over the role of commissioner in May 2017, Gottlieb has aggressively supported the approval of new branded drugs, as well as generics. Additionally, he has taken on multiple public health problems including the opioid epidemic sweeping the country and vaping.

According to the Post, Gottlieb’s resignation caught the White House by surprise. He is well-liked by the Trump administration and was hired for his aggressive approach to reshaping the federal regulatory agency.

Health and Human Services Secretary Alex Azar said he is proud of the work Gottlieb has accomplished during his two years at the head of the FDA. Azar called him an aggressive advocate for American patients and a passionate promoter of innovation. Gottlieb’s leadership inspired historic results and delivered “record approvals of both innovative treatments and affordable generic drugs,” Azar said in a statement.

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Since taking over at the FDA, Gottlieb has used his Twitter account to inform the public about a variety of initiatives he has taken, as well as to keep the public abreast during the month-long shutdown earlier this year. On Tuesday, after news of his resignation broke, Gottlieb took to Twitter to express how grateful he was for the opportunity to lead the FDA.

"This has been a wonderful journey and parting is very hard," he said.

President Trump praised Gottlieb for his time at the helm of the agency. He also took to Twitter to express his gratitude for Gottlieb's efforts to lower the cost of prescription drugs and approve more generic treatments.

Last month, Gottlieb laid out new steps the FDA planned to take to address the opioid crisis. Gottlieb said the agency has changed its approach to the opioid crisis and will take a more aggressive approach on regulatory actions. In his announcement, Gottlieb noted that the agency made a mistake to wait for “the accumulation of definitive evidence of harm” kept the FDA behind a crisis that was quickly, and sometimes unnoticeably evolving in communities across the country.

Also in February, Gottlieb outlined a new pathway for the accelerated review of generic drug applications as part of the FDA’s efforts to increase competition and lower drug prices in the United States. Gottlieb said the agency has been taking steps to support “downward pressure” on drug pricing, which means that they want to influence increased competition through more generic drugs. Gottlieb said there are many branded drugs on the market that have no generic competition, which may keep prices high and “ultimately hurt American patients.” Gottlieb said the FDA is working to reduce barriers to generic development and to lower the cost of generic entry into the marketplace in order to spur an increase of such options for patients.

During his tenure, Gottlieb also supported the development of biosimilar drugs for the U.S. market as well as cracked down on unauthorized use of plasma treatments in bogus anti-aging treatments.

Before his most recent stint with as FDA commissioner, Gottlieb had a long career in public health policy. From 2003 to 2004, Gottlieb was a senior adviser to the FDA commissioner and then the agency’s director of medical policy development. In 2004, Gottlieb took on a role as senior adviser to the Centers for Medicare and Medicaid Services. And then from 2005-2007, he served as the FDA’s deputy commissioner for medical and scientific affairs. In addition to his work in public health, Gottlieb has also served as a consultant for companies such as Novo Nordisk, GlaxoSmithKline and Daiichi Sankyo. Prior to becoming FDA commissioner, Gottlieb held a role as a venture partner at New Enterprise Associates and also as a resident fellow at the American Enterprise Institute, a conservative think tank.

With Gottlieb stepping down from the role of commissioner, the question will now turn to who will replace him. It is too soon to tell at this point, but the White House could float some of the names it initially considered for the role, including Jim O’Neill, who has a history of calling for reforms at the FDA, including allowing for the approval of drugs after they have been proven safe, but have not yet necessarily proven efficacy.

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