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FDA commissioner Scott Gottlieb is resigning

by Thomas Dworetzky, Contributing Reporter | March 06, 2019

During his leadership, the agency also supported “major legislative efforts to secure a more modern framework for the efficient regulation of diagnostic tests and over-the-counter drugs” and made “efforts to address the opioid crisis with historic new authorities and resources,” as well as a focus on care for the troops and interdiction work inside the International Mail Facilities.

The FDA also had to face historic crises during Gottlieb's 23 months, including managing drug shortages in Puerto Rico, and protecting the public during the shutdown.

The move came as a surprise, considering that Gottlieb had tweeted January 3, that rumors he was quitting were untrue.

“I’ve heard from friends contacted by an online pharma news pub that’s preparing a story speculating that I’m leaving #FDA,” he tweeted, adding, “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 road map soon.”

Apparently, this has been in the works for a while. A source inside the FDA reportedly advised that it's happening because of “'the difficulty of commuting back and forth between' Washington and Connecticut, where Gottlieb's three young children live,” according to Axios.

"All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA," Azar said in a statement. "He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family," according to CBS.

But some consider Gottlieb's approach too permissive – speeding and easing regulations and approvals.

“We’re not sad to see him go,” director of the Health Research Group Michael Carome, a Gottlieb-appointment opponent, told the Los Angeles Times, adding, “he was entangled in an unprecedented web of ties to Big Pharma.”

His detractors point to the approval of baricitinib, sold as Eli Lilly's Olumiant, for rheumatoid arthritis – even though drug was rejected in 2017 because of reports of blood clots, according to the paper.

Critics also suggest that the agency “undermined” its own efforts to combat the opioid crisis, when it OK'd the potent new under-the-tongue opioid drug, Dsuvia, according to the paper.

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