Former FDA Head Calls Azar’s Rule-Making Move a ‘Distraction’

(Bloomberg) -- Former FDA commissioner Scott Gottlieb said Health and Human Services Secretary Alex Azar’s move to bar agencies under his authority from signing their own rules is a “major distraction” that creates “an implication, or at least a specter” that the FDA’s independence is being eroded or influenced.

“The timing of this is really poor right now, because it’s going to distract the agency and frankly creates headlines that could leave the perception that the agency is being bullied,” Gottlieb said on CBS on Sunday.

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 Saturday. The report cited a Sept. 15 memo by Azar that was sent to HHS leaders and said rule-signing authority is “reserved to the Secretary.”

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 whether 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.

Gottlieb doesn’t see a scenario where Trump could override the FDA to green-light a vaccine “where it’s not readily apparent” to the public. He also doesn’t expect manufacturers to commercialize a vaccine without the consent of FDA health professionals.

Nevertheless, the move could give conservative groups a foothold and create an avenue for them to challenge tobacco rules legally, Gottlieb said.

More broadly, the action will make it harder for the FDA to do rule-making on the nation’s foods, medicines, medical devices and other products, the newspaper said.

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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