On August 30, 2021, Health and Human Services (HHS) Secretary Xavier Becerra issued a Notice that reversed former HHS Secretary Alex Azar’s September 15, 2020, memo that rescinded “any prior delegation of rulemaking authority” at the Food and Drug Administration (FDA).
Azar’s 2020 Memo
In his 2020 Memo, Azar required that all rules “for which notice and comment would normally be required, irrespective of whether notice and comment is waived” coming out of agencies under the Health and Human Services umbrella would need to be signed by the Secretary. The memo also rescinded “any prior delegation of rulemaking authority” to the Operating Divisions, including the FDA.
At the time, HHS said the memo was meant to minimize “litigation risk for the department’s public health actions” and prevent any potential abuse of authority.
However, shortly after news of the memo became public, swift backlash hit from many different stakeholders and other parties.
Becerra’s 2021 Memo
In his memo, Becerra revoked the 2020 memo as applicable to the FDA and reinstated any delegations to FDA that were rescinded by Azar’s memo.
Becerra noted that his delegation “shall be exercised in accordance with the Department’s applicable policies, procedures, and guidelines.” Further, “this delegation is subject to certain reservations of authority for the Secretary to approve FDA regulations,” specifically the authority to approve regulations of FDA that either (1) establish procedural rules applicable to a general class of foods, drugs, cosmetics, medical devices, tobacco products, or other subjects of regulation or (2) present highly significant public issues involving the quality, availability, marketability, or cost of one or more foods, drugs, cosmetics, medical devices, tobacco products, or other subjects of regulation.
Becerra went on to note that the above reservation of authority is intended only to improve the internal management of HHS, and it is not intended to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, HHS, the FDA, any Agency, officer, or employee of the United States, or any person. Regulations issued by FDA without the approval of the Secretary are to be conclusively viewed as falling outside the scope of this reservation of authority.
Reaction from Former FDA Commissioner Scott Gottlieb
“Good to see HHS reversing policy decision by their predecessors that would have greatly limited FDA’s discretion to issue public health regulations,” former FDA commissioner Scott Gottlieb wrote on Twitter. “This decision by current HHS will restore an essential element of FDA’s independent judgement and allow the agency to act faster.” Gottlieb previously spoke out against Azar’s memo, calling it a “major distraction” in the midst of COVID-19 relief efforts, “I’m not sure what is to be gained with a management change with respect to FDA when they are doing such critical work.”