Health Agencies Need Secretary Approval for New Rules: NYT

Health and Human Services Secretary Alex Azar has barred agencies under his authority, including the U.S. Food and Drug Administration, from signing new rules, the New York Times reported.

The FDA is a key agency guiding the decisions in the development of a Covid-19 vaccine — and the Times reported that it was unclear if Azar’s move would change that process. The FDA has been under political pressure for quick movement, with President Donald Trump predicting approval of a vaccine sooner than senior administration officials foresee.

More broadly, the action will make it harder for the FDA to do rulemaking on the nation’s foods, medicines, medical devices and other products, the newspaper said. It cited a Sept. 15 memo by Azar that was sent to HHS leaders and said rule-signing authority is “reserved to the Secretary.”

Brian Harrison, Azar’s chief of staff, described the new policy as “a housekeeping matter” aimed at no agency in particular, the Times said. Harrison said the change would have no bearing on how the agency deals with coronavirus vaccines.

The Times quoted Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner of the FDA, as calling Azar’s move “a power grab” that could slow new rules.

The FDA puts forth more regulations than other agencies at HHS, except for the Centers for Medicare & Medicaid Services, which already requires the secretary’s signature on new rules, the Times said.

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