FDA Commissioner Scott Gottlieb to Step Down

08 March, 2019, 02:25 | Author: Billie Castillo
  • Gottlieb testifies during a Senate Health Education Labor and Pensions Committee hearing

Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA's Deputy Commissioner for Medical and Scientific Affairs.

Some in the public health and health policy communities praised his work on vaping, drug pricing, and other issues.

"He could govern from a place of moderation and get all the more credit because so many other agencies and positions under the Trump administration were either falling apart or vacant", said Carpenter, who has written extensively on the FDA. In early February, the FDA pursued enforcement actions against some Walgreen and Circle K locations.

"I was totally shocked; we were definitely not expecting this", said Antonio Ciaccia, cofounder and researcher at 46Brooklyn Research, a non-profit drug pricing research firm in Columbus, Ohio.

"However, at the same time, we are unaware of what the underlying cause of Mr Gottlieb's resignation was, noting the multifaceted authority of the FDA and the numerous controversies within its purview", the analysts added.

"All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA", Secretary Alex Azar said in a statement.

It closed down 0.5 per cent as shares of Amgen Inc erased gains and Gilead Sciences Inc shares fell further. "We are really in that "Never-Never Land" with him right now, and that couldn't be more true with regard to tobacco", Matt Myers, president of the Campaign for Tobacco-Free Kids in Washington, said in an interview. "That just happened to be one of them".

London-quoted British American Tobacco and Imperial Brands both saw their shares rise on Wednesday, while overnight US-quoted 22nd Century Group, which is focused on nicotine reduction, lost almost 30% of its value.

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"He has been the driver of the menthol ban, and now the sector is totally under-owned", said one London-based trader. Gottlieb announced in July 2017 the FDA would seek to require tobacco companies to drastically cut nicotine in cigarettes, in a bid to help adult smokers quit. His departure coincided with pushback from Congress and conservative circles against the FDA's aggressive efforts to crack down e-cigarette sales.

Biosimilar developers were in harmony with that assessment; the Biosimilars Council, a division of the Association for Accessible Medicines, told The Center for Biosimilars in an email that a "testament to his commitment to bringing more affordable generic and biosimilar medicines to patients are the record number of approvals seen during his tenure". He and his talents will be greatly missed!'

After Trump's election, Gottlieb had widely been viewed as the front-runner to lead the agency.

Hours later, news of his resignation emerged, reported first by the Washington Post on Tuesday afternoon.

The 46-year-old physician, millionaire venture capitalist and cancer survivor from CT have chose to spend some time with his family, which consists of his wife and three daughters.

As it relates to the U.S. tobacco industry, the change in FDA leadership "puts up for debate what the agency has been discussing and exploring as Commissioner Gottlieb has become synonymous with the actions of the FDA", but it was not clear if its was controversy over any aspect of the multifaceted FDA controversies had led to his departure. Before becoming head of the FDA, he was a longtime healthcare investor and consultant who sat on multiple company boards.

He surprised critics who anxious about his ties to the pharmaceutical industry by speaking out about rising drug prices and drug company tactics to keep competitors off the market.

Scott Gottlieb is stepping down as leader of the FDA - and many in health and medicine quickly turned to Twitter to express their displeasure. "As Congress debates solutions to rising health care costs, it's been voices like Commissioner Gottlieb's that are needed to properly highlight the safety, effectiveness and lower costs of these treatments and combat the rampant misinformation that is hurting the United States biosimilars market". While the FDA does not have a mandate to address the issue of drug prices, Gottlieb promoted competition as a way for the agency to play a more active role.

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