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FDA Approves Powerful Opioid Despite Fears of More Overdose Deaths

Scott Gottlieb is an American physician and investor who US President Donald Trump appointed to serve as commissioner of the Food and Drug Administration in May 2017. Prior to assuming the position, he was a resident fellow at neocon think tank American Enterprise Institute, FDA Deputy Commissioner for Medical and Scientific Affairs and an investing partner at the venture capital firm New Enterprise Associates. PHOTO: John Shinkle/POLITICO

By Lenny Bernstein | 2 November 2018

THE WASHINGTON POST — The Food and Drug Administration approved a powerful opioid Friday for use in health-care settings, rejecting criticism from some of its advisers that the drug would inevitably be diverted to illicit use and cause more overdose deaths.

The opioid is five to 10 times more potent than pharmaceutical fentanyl. A tiny pill that is just three millimeters in diameter, it is likely to worsen the nation’s drug crisis, according to critics and the head of the FDA’s advisory committee on painkillers.

FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market, which might allow the agency to turn down future applications for new opioid approvals.

“We need to address the question that I believe underlies the criticism raised in advance of this approval,” Gottlieb wrote. “To what extent should we evaluate each opioid solely on its own merits, and to what extent should we also consider . . . the epidemic of opioid misuse and abuse that’s gripping our nation?” […]

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