As the Biden administration prepares to end the COVID-19 public health emergency on May 11, the FDA must decide what to do with dozens of temporary guidances issued during the public health emergency.

And the answer isn’t clear-cut.

The agency said it will publish a Federal Register notice to explain how the change “will impact the agency’s COVID-19-related guidances and which of those guidances it is temporarily extending or letting expire,” the agency said in a Jan. 31 website posting.

But while the posting did not offer certainty for what will happen to the 76 COVID-19-related guidances issued since March 22, 2020, the FDA did offer answers for products authorized for emergency use during the pandemic.

The ending of the public health emergency “will not impact FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use,” the agency said, adding that existing Emergency Use Authorizations (EUA) for products “will remain in effect and the agency may continue to issue new EUAs going forward.”

Some experts have weighed in on what the declaration of the end of the emergency will mean for products and for emergency guidance.

“Typically, when HHS declares a public health emergency to be over, product EUAs, emergency guidance, etc., will sunset,” said Kevin Potgieter, vice president of regulatory affairs at Medable, a company that has developed a platform for decentralized clinical trials.

“With the sheer number of affected items, I would hope there is a phase-out period, as opposed to an arbitrary date in the near term,” Potgieter said. “Pharma, device, biologics, [in vitro diagnostics], public health authorities, hospitals/clinics, etc., would all be affected in significant ways.”

Kalah Auchincloss, executive vice president and deputy general counsel of the regulatory consulting firm Greenleaf Health agreed. The FDA “has been planning for the end of the [public health emergency] for some time — I don’t think it’s a big surprise that Biden is not renewing,” Auchincloss told FDAnews.

“There are many guidances that technically sunset when the [emergency] ends, but the FDA will work to make the transition as smooth as possible for industry and patients,” she said. “I imagine some guidances will end but others will be reissued as traditional draft guidances with an opportunity for notice and comment before they become final.”

But Auchincloss also expressed concerns about how clear the process will be. “I hope FDA is transparent about expectations for industry during the transition — some kind of roadmap would be very helpful.”

Theoretically, a declaration that the public health emergency is over could happen sooner than May. On Jan. 31, House Republicans passed the Pandemic is Over Actin a party-line vote of 220 to 210 to end the emergency the day the legislation is enacted. But the bill has little hope of passing in the Democratic-controlled Senate — or of getting President Biden’s signature if passed.

In related news, the agency took another step toward the end of pandemic restrictions, announcing that, beginning Feb. 13, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will resume some in-person face-to-face industry meetings while continuing the current virtual meeting format. — Jason Scott