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09/21/2020

Health Secretary Azar Asserts Authority Over F.D.A.

Many are calling this an unprecedented "power grab"

This week, in a stunning declaration of authority, Alex M. Azar II, the secretary of U.S. Health and Human Services (HHS), this week barred the nation’s health agencies, including the Food and Drug Administration (FDA), from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

Going forward, Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power “is reserved to the secretary.” The bulletin was sent to heads of operating and staff divisions within HHS.

It’s unclear if or how the memo would change the vetting and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States. Political appointees, under pressure from the president, have taken a string of steps over the past few months to interfere with the standard scientific and regulatory processes at the health agencies. For example, a much criticized guideline on testing for the coronavirus was not written by C.D.C. scientists, and was posted on the agency’s public website over their objections. It was reversed on Friday.

Please select this article to read the complete article from The New York Times.

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