Covid-19 vaccines, therapies, and other related products are available in the U.S. thanks to more than 400 emergency use authorizations granted by the FDA during the pandemic.
Nearly all of those products are at risk of being taken off the market once the declaration for the public health emergency ends—unless and until they attain full approval. The Food and Drug Administration has been working on guidance for almost a year on how to transition from emergency status, but businesses need to start preparing now, attorneys say.
“The sheer volume of authorized products could be potentially very disruptive, if not transitioned well by FDA,” Stacy Cline Amin, who until January was the agency’s chief counsel and now co-leads the FDA practice at Morrison & Foerster LLP, said. “FDA is aware of that and thinking about it.”
The agency’s EUA mechanism allows the agency to make unapproved products or new uses of approved products available during a public health emergency if the known and potential benefits outweigh the known and potential risks. Once the health and human services secretary ends the emergency declaration, so too do those authorizations.
An FDA spokesperson confirmed the agency’s plans to offer recommendations to help companies transition their products from an EUA. Companies should seek full approval for their products even without that guidance, because an agency that’s already overworked will unlikely be able to handle hundreds of submissions at once.
“They definitely should be thinking about going through the approval process, and they should be working with their counsel to start that process,” Amin said. “And I would do that as quickly as they could.”
Before Covid-19, the FDA typically issued a handful of EUAs for each emergency. There is a combined total of 62 EUAs between 2008 to 2020 in response to threats from H1N1, MERS, Zika, and other emergencies.
There are already 447 EUAs as of July 1 in response to Covid-19—more than seven times the number of authorizations issued for all past emergencies combined. That number doesn’t include revoked authorizations, and some of these are umbrella EUAs so that several products, such as a bunch of respirators, are made available through a single EUA.
The FDA has made a total of 881 medical countermeasures available under EUAs as of July 1. That includes everything from tests to vaccines to medicines to personal protective gear such as N95 masks. As of Tuesday, the FDA has authorized 576 revisions to EUAs.
HHS Secretary Xavier Becerra has said the end of the public health emergency will be driven by scientific evidence and not politics. He extended the emergency July 19 for another 90 days.
EUAs are granted for the duration of the emergency unless otherwise revoked or revised, Veleka R. Peeples-Dyer, chair of Baker McKenzie’s food and drug law practice, said. When an EUA is revoked, the product “must be disposed per the FDA’s regulations,” with exceptions.
Businesses thinking of transitioning their Covid-19 products from emergency status to full approvals should start having informal discussions with the FDA, Randy J. Prebula, director of Hogan Lovells’ FDA medical devices and technology practice, said. That will help them evaluate any real-world data they’ve collected while their product was used under an EUA.
“Be proactive in thinking about what data you already have. If you’re proposing to FDA alternative sources of information, have a dialogue with them about that,” he said. “The more dialogue you have with FDA, the greater certainty you’re going to have.”
Companies can look to tests it’s already cleared, such as the BioFire Respiratory Panel 2.1, which the agency approved in March, “to see the kinds of things they’ve asked for,” Prebula said.
The FDA spokesperson said “companies seeking full marketing authorization for products with EUAs are urged to come in as soon as possible.”
Use of EUAs isn’t new. Congress in 2004, through the Project BioShield Act, gave the FDA this authority for when the HHS secretary declares a public health emergency and that it’s appropriate for the FDA to issue EUAs.
The law that allows the FDA to issue EUAs—Section 564 of the Food, Drug and Cosmetic Act—calls for providing a reasonable period of time to dispose of any products under the EUA or change the labeling on products used for the emergency but approved for other purposes.
“Reasonable is the kind of word that is used to give the agency a lot of discretion,” Amin said. She noted the statute gives the FDA a good amount of flexibility to figure out how to handle the transition out of the public health emergency.
It also means that the FDA can provide uniform guidance to companies in a way that won’t overwhelm the agency with hundreds of distinct approval requests, Amin said. The agency has been talking about drafting such a document since September 2020.
“Guidance like this is very important,” she said. But she also said it will be “very complicated” because the recommendations will have to take into account every product area.
“Even if each center ends up issuing their own guidance, there’s likely a lot of cross collaboration required among the different medical product centers,” Amin said. “That is probably the reason why we haven’t seen a draft yet. But I know it’s a top priority for the agency and so I would expect that we would probably see one soon.”
Volume of Requests
The guidance will likely clarify which regulatory pathways companies can use to seek full approval and what data companies will need to submit, Amin said. The FDA also will likely lay out a timeline for when companies should apply for full approval and what the status of that product is under review.
“It may be the case as well” that the FDA is considering some sort of enforcement discretion period to allow products to stay on the market and to give companies more time to submit for a full review, Amin said. “Obviously public health is going to be paramount for the agency as they consider what kind of guidance to give industry.”
The FDA may also spend less time or offer less flexibility for products issued under an EUA if there are already similar products cleared under full approval, or if there’s a sufficient number of supply to meet demand. “That’s something that they’ll be thinking about. But they’re also going to be thinking about their resources,” she said.
The agency will need to consider what it can handle in terms of the volume of requests and its capacity to keep up with that as well as continuing demands on the agency in other areas.
The U.S. government can choose not to rescind the emergency declaration so any products authorized on that basis are still available, Prebula said. “There’s no significant risk right now of Ebola being imported into the United States because there’s low incidence of disease in other countries, but the declaration has stayed open.”
The emergency also may not go away anytime soon with the emergence of new variants and as the pandemic continues to rage globally, Amin noted.
“It may not be the case that the public health emergency for us is really, you know, coming to a quick close,” she said.