In 'Power Grab,' Health Secretary Asserts Authority Over FDA
In a stunning declaration of authority, Alex Azar, the secretary of Health and Human Services, this past week barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.
Going forward, Azar wrote Tuesday in a 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 U.S. clinical trials. Political appointees, under pressure from President Donald Trump, 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 scientists at the Centers for Disease Control and Prevention, and was posted on the agency’s public website over their objections. It was reversed Friday.
Outside observers were alarmed by the new memo and worried that it could contribute to a public perception of political meddling in science-based regulatory decisions. Dr. Mark McClellan, who formerly headed the FDA and now runs Duke University’s health policy center, praised the agency’s work on vaccine development but said the policy change was ill-timed.
https://news.yahoo.com/power-grab-health-secretary-asserts-152243411.html
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