FDA Chief Scott Gottlieb steps down, leaving pet projects behind

  • March 07, 2019

Gottlieb won Senate confirmation as FDA Commissioner back in May 2017, an uncertain time for the drug industry.  During the selection process, his name had been favored by a majority of biopharma executives polled by an analyst.  At the time, one anonymous executive said he is the “least likely to rail for the obliteration of the current efficacy, safety, risk-benefit model that is a foundation for advancement of new treatments in the United States” — unlike at least one other candidate for the job.

That preference proved out after Gottlieb took over the Agency (FDA), as his policies favored speed and competition.  Additionally, when the news broke Tuesday afternoon, the industry trade group PhRMA praised his “exemplary leadership.”

“During his tenure, he focused on innovation in drug development and review, increased competition, and advanced the regulatory framework for approving novel technologies, including gene therapies,” the organization said in a statement.  “His efforts have made a meaningful impact for patients in need of innovative medicines.”

Gottlieb tweeted Tuesday that he is “immensely grateful” for the opportunity to lead the FDA.  President Donald Trump added that he has done an “absolutely terrific job” and will be missed.

In his resignation letter, tweeted by STAT reporter Matthew Herper, Gottlieb reviewed his efforts at the Agency over the past two (2) years.  It is a long list and here are a few examples:  The FDA worked to avoid drug shortages after a hurricane struck Puerto Rico; led a global investigation into drug impurities;  advanced reviews of cell and gene therapies; and bolstered approvals of complex generic drugs.  Also under his command, the FDA took quick and decisive action on drug costs.  The Commissioner worked to boost generic approvals and crack down on regulatory “gaming” that stifles competition.  He additionally blamed branded drug companies for an “anemic” U.S. biosimilars market and recently blasted insulin pricing.

His sudden departure will likely leave many Agency efforts to lower costs up in the air.

During his tenure as FDA Commissioner, Gottlieb’s name had been floated for HHS Chief when former HHS secretary Tom Price resigned due to a travel scandal; however, Gottlieb said he was best suited for the FDA Commissioner job.  Now, former Eli Lilly executive Alex Azar serves as the Department of Health and Human Services (DHHS) Secretary, and on Tuesday afternoon, Azar praised Gottlieb for his work at the FDA.

REFERENCE:  Fierce Pharma; 05 MAR 2019; Eric Sagonowsky

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