The Food and Drug Administration (FDA) will see a change in leadership as commissioner, Scott Gottlieb, leaves the helm of the agency next month, despite presiding over a period that saw record drug approvals and increased communication to stakeholders.
According to the Washington Post, in his resignation letter, given to Health and Human Services Secretary, Alex Azar, Gottlieb stated he is resigning to spend more time with his family, after commuting to Washington, D.C. from Westport, CT.
Gottlieb handed in his resignation two months after he publicly denied reports that he was planning to step down.
I’ve heard from friends contacted by an online pharma news pub that’s preparing a story speculating that I’m leaving #FDA. I want to be very clear - I’m not leaving. We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon pic.twitter.com/0xQuXnSPbo— Scott Gottlieb, M.D. (@SGottliebFDA) January 3, 2019
Gottlieb handed in his resignation on Tuesday, after publically criticizing the drugstore chain Walgreens Monday for selling tobacco products to minors, “the company’s stores have racked up almost 1,800 violations across the country,” he said in a statement.
In April, Gottlieb told CNN that while opioids are the biggest crisis facing the FDA, tobacco and e-cigarette use among teenagers could be deemed an epidemic. He has taken actions on both ‘epidemics’ approving therapies for opioid withdrawal, cracking down on opioid manufacturers, and working to pass guidances on e-cigarette usage.
President Donald Trump appointed Gottlieb to the position of commissioner in May 2017. Following the news of his resignation, Trump tweeted:
....Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!— Donald J. Trump (@realDonaldTrump) March 5, 2019
While Gottlieb led the FDA in 2018, the agency approved or tentatively approved 1,021 abbreviated new drug applications, published more than 250 new or revised guidances, launched an online function for controlled correspondence and responded to 700 inquiries, and issued 2,659 complete response letters.
Notably, 2018 was a record year for drug approvals with 59 novel drugs and biologics approved in the course of the year, which improved upon the previous record of 53 approvals in 1996.
Additionally, in 2018, the FDA approved the first generics for Suboxone, EpiPen, Zortress, Copaxone, and Brilinta, with Gottlieb often emphasizing the potential for generics to improve patients’ access to affordable drugs and releasing a draft guidance for generic competition.