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Scott Gottlieb, US FDA Commissioner, Walks Out

Scott Gottlieb, the U.S. FDA (Food and Drug Administration) commissioner, has resigned, as per The Washington Post. The shift, which Gottlieb has proclaimed is as he wanted to spend more time with his family, apparently came as a shock to senior White House officials. Alex Azar, Secretary, HHS (Health and Human Services), verified the news.

In May 2017, Gottlieb took the charge as FDA commissioner. Reportedly, he had been a topmost official at the agency during the George W. Bush administration period. When his name was initially proposed to be the head of FDA, critics highlighted his connections to the sector and his work for pharmaceutical firms such as GlaxoSmithKline. This was supposed to be a work that netted him more than $400,000 in compensation between 2013 and 2015. Yet, he was selected with a 57–42 vote in the Senate following promising to dissociate from few health care firms.

On a similar note, the U.S. FDA came into the news as it revealed that it has approved esketamine (Spravato) nasal spray. This spray is supposed to be used in combination with an oral antidepressant for the depression treatment in adults who have attempted other antidepressant medicines, however, did not get benefit from them. This situation is called as the treatment-resistant depression. Owing to the threat of severe adverse outcomes resulting from sedation and dissociation due to Spravato administration, and the prospective for misuse and abuse of the medication, it is only open for use through a limited distribution system, under REMS (Risk Evaluation and Mitigation Strategy).

Tiffany Farchione, M.D., Acting Director, Division of Psychiatry Products, Center for Drug Evaluation and Research, FDA, proclaimed that there has been a long-standing requirement of new effective treatments intended for treatment-resistant depression. He added that this is a severe and life-threatening health condition.

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