FDA chief Scott Gottlieb to resign
Food and Drug Administration chief Scott Gottlieb announces his intention to step down in one month.
This week, Food and Drug Administration (FDA) Commissioner Scott Gottlieb submitted his resignation to Health and Human Services Secretary Alex Azar, effective next month. The reason he gave is he wants to spend more time with his family, as he’s been commuting weekly from his Connecticut home to Washington, D.C.
Gottlieb had been a top FDA official during the George W. Bush administration. His experience as a physician, cancer survivor, venture capitalist, and conservative health care economic guru, made him a strong candidate when President Trump was appointing someone to the post. He took office in May 2017.
Almost two years later, he is walking away with a list of accomplishments including accelerating the approval of generic drugs and modernizing the process for handling novel gene and precision therapies to treat those with cancer and other devastating diseases.
FDA CHIEF SCOTT GOTTLIEB RESIGNING
He is also credited with leading the FDA in moments of crisis, including its work in Puerto Rico following Hurricane Maria in 2017 and the drug and medical device shortages that devastated the island.
Gottlieb took a firm stance against rising drug prices and worked in unconventional ways to push prices lower. Although not typically regarded as the FDA’s role, his experience as a physician and venture capitalist gave him leverage in combating escalating drug prices.
Last year alone, the FDA approved a record 971 generic drugs by loosening regulations to bring new generics forward in an effort to drive price competition. Furthermore, Gottlieb began posting lists of drugs that aren’t protected by patents, inviting applications from generic manufacturers to join the marketplace, and sharply criticized monopolistic brand-name companies for obstructing generic price competition.
Gottlieb made his position clear – he was on the side of Americans, not drug company profiteers.
In addition to criticizing the brand-name companies, last month, Gottlieb announced the agency had also sent warnings to companies selling supplements containing unapproved drugs and making illegal claims for treating Alzheimer’s disease and other serious conditions.
Gottlieb also was faced with taking a position during the devastating opioid crisis. Under Gottlieb, in 2017, the FDA removed the opioid medication Opana from the market. The drug’s manufacturer, Endo Pharmaceuticals, had made the drug more difficult to crush and snort in 2012, but the FDA said that move actually led to more injectable usage, thus resulting in a major HIV infection surge.
Most recently Gottlieb proposed limiting sales of most flavored e-cigarettes (except mint and menthol). Now known as Gottlieb’s signature issue, youth vaping is being reviewed by the White House Office of Management and Budget. The plan, detailed by Gottlieb last fall, would sharply restrict the sale of flavored e-cigarettes to curb a surge in underage vaping, and the potential long-term consequences of a new generation of addiction.
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Gottlieb’s presence and leadership will be missed but his initiatives must continue. We are still facing rising drug prices, a crippling opioid crisis, and increasing use of flavored e-cigarettes. Swift replacement of the position will be necessary.
Gottlieb’s predecessor, Dr. Robert Califf, faced scrutiny during his 10-month tenure for his ties to industry – particularly from Bernie Sanders. With the upcoming 2020 election, President Trump will be mindful that whomever he chooses will face intense scrutiny too.
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