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Public Policy Newsletter Article

HHS Secretary Azar Bars FDA from Signing New Rules

  • 2020-09-24T14:30:00.000+0000
  • Author: Brittany Blocker

On September 15, the Department of Health and Human Services (HHS) Secretary, Alex Azar, issued a memorandum giving him authority over all new rules and barring 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.

It is currently unclear if or how the memo would impact the vetting and approval process for coronavirus vaccines. Azar’s Chief of Staff, Brian Harrison, stated that the changes were a housekeeping action, which should have no operational impact because all rules already required departmental clearance. Harrison stated the change is consistent with congressional intent and would prevent potential future abuse of authority. He also emphasized that it has nothing to do with guidance, vaccine, drug, or therapeutic approval.

Some experts believe that the memo could further hinder scientific voices. Former FDA Commissioner, Scott Gottlieb, said Secretary 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.” He believes the timing of this is really poor and could distract the agency and create headlines that could leave the perception that the agency is being bullied.