martes, 22 de septiembre de 2020

HHS Statement on Regulatory Process | HHS.gov

HHS Statement on Regulatory Process | HHS.gov

D.C. Diagnosis

Lev Facher

Could the HHS 'power grab' affect FDA’s authority on vaccines? 

HHS issued a bizarre memo over the weekend that rescinded the authority of smaller agencies like FDA, CDC, and NIH to finalize regulations without the signature of health secretary Alex Azar. It was a clear “who’s in charge” message from HHS, though the agency took pains to emphasize that it won’t impact FDA’s ability to authorize a Covid-19 vaccine. A vaccine approval isn’t a regulation, but the memo still left FDA experts scratching their heads about its true purpose, given the context.

Besides, the HHS secretary already has the power to issue emergency use authorizations, though such decisions are typically delegated to FDA.

“Whatever is going on here, this is very worrying,” said Patricia Zettler, an Ohio State University law professor and FDA expert. “If it’s true this memo has no effect on HHS agencies’ decision-making, as the Q&A on HHS’s website says, why make this change right now?”

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