Rulemaking authority restored at FDA as a show of support in a tumultuous time
Just a day after two top career vaccine leaders at FDA retired at a key moment of the pandemic, HHS has now formally reversed a questionable Trump-era memo that had abolished FDA’s ability to write new rules.
That memo from then-HHS Secretary Alex Azar, issued Sept. 15, 2020, rescinded “any prior delegation of rulemaking authority” at the FDA. On Wednesday, however, HHS Secretary Xavier Becerra issued a delegation that revoked the 2020 memo as it applies to FDA, and reinstated any delegations to FDA rescinded by the memo.
Effectively, the move is a show of support from HHS’ top political appointee, restoring FDA’s autonomy to the pre-Trump days, and paving the way for FDA to continue its rulemaking agenda, which typically involves rulemakings to ensure the safety of medical products and improving public health.
“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 and Pfizer board member 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.”
The fig leaf from HHS comes as FDA continues to reel from the departure of two key vaccine leaders while grappling with a pressing timeline on Covid-19 vaccine boosters and children’s vaccines later this fall and winter.
Azar’s HHS claimed in 2020 that the memo was necessary because while in some cases rules were signed by the HHS secretary and by the head of the agency involved, in other cases, other officials to whom authority had been delegated signed the rules.
Gottlieb told CBS’ Face the Nation on Sept. 20, 2020 that the memo was a “a major distraction” from Covid-19 relief efforts, and it could call into question all of the rules that were signed by lower-level people who were delegated to sign the rules. He said when he was commissioner at FDA, he re-codified the tobacco deeming rule because the agency feared something like this might occur.
Mark McClellan, former FDA commissioner and now head of Duke University’s health policy center, told the New York Times at the time, “We’re in the midst of a pandemic, when trust in the public health agency is needed more than ever. So, I’m not sure what is to be gained with a management change with respect to FDA when they are doing such critical work.”
In addition to this reversal, Biden’s HHS has reversed a few other FDA-related Trump-era initiatives, including decision to pull the FDA’s controversial Unapproved Drugs Initiative, another notice that would’ve required the FDA to publish redundant information on the timelines for reviewing drug applications, and two requests for proposals on the reimportation of insulin and the personal importation of prescription drugs.