The current public health emergency (PHE) is set to expire on April 16. While the Biden administration is likely to extend the PHE, administration officials have yet to comment on their specific plans. Uncertainty over the end of the PHE has fueled conversations over what the implications would look like for temporary health care policies that expire once the PHE officially concludes.
Blog posts from the last two weeks have looked at how the end of the PHE would affect Medicare’s temporary telehealth waivers and Medicaid coverage. This week’s blog post focuses on how ending the PHE would impact the Food and Drug Administration’s (FDA) emergency use authorizations (EUAs).
Background: An EUA allows the FDA to authorize unapproved medical products or unapproved uses of approved medical products – like vaccines and treatments – to be used to diagnose, treat, or prevent serious or life-threatening diseases in cases where there are no adequate, approved, and available alternatives. Since the start of the COVID-19 PHE on January 31, 2020, the FDA issued hundreds of EUAs for pharmaceutical and medical devices related to COVID-19.
How? Section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act allows the FDA to issue four different types of EUAs during a PHE for diagnostics, respiratory equipment, medical devices, and drugs/biologics. However, the FDA still has the authority to issue an EUA outside of a PHE thanks to the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, which grants Department of Health and Human Services flexibility to declare that “circumstances exist” outside of a PHE to allow EUAs to be issued.
What does the end of the PHE mean for the EUAs? Unlike the other temporary authorities related to telehealth and Medicaid, all EUAs that are issued by the FDA remain in effect until the FDA withdraws the EUA declaration. For instance, the EUA declarations issued for the Zika and Ebola pandemics were never withdrawn and are currently in effect, even though their respective PHEs have long since expired.
However, one FDA policy, separate from EUAs, will expire at the conclusion of the PHE – enforcement discretion. This policy allows the FDA to waive enforcement of its usual requirements for pre-market approval to allow drug products to be modified for additional uses without full approval from the agency. In contrast, drug products approved via an EUA must still meet specific criteria on safety and effectiveness. Once the PHE ends, the FDA will revert to its regular enforcement policies, and all products where enforcement discretion once applied must then meet all standard FDA legal requirements in order to continue to be sold in the US.
Planning for a Post-EUA Future
Unlike the EUAs for Zika and Ebola treatments, the FDA has communicated that it doesn’t want the COVID-19 EUAs to stick around forever and manufacturers should expect an “eventual resumption of normal operations.” To this end, the FDA issued two draft guidance documents in late December to help facilitate a return to normal:
- Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency. This provides a plan for manufacturers of drug products that received an EUA to seek formal market access (including a three-phase transition process with specific timelines for complying with regulations and submitting market application). It says HHS would issue an advanced notice of termination of the EUA declaration 180 days in advance.
- Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency. This would also allow a three-phase transition process for manufacturers to seek formal market access decisions for modified use of their products, or to revert their products back to previous authorizations.
Uncertain Future for Stakeholders
On February 22, the FDA held a webinar for industry stakeholders about its draft guidance documents on its post-pandemic transition plans, and like their counterparts in telehealth and Medicaid, the stakeholders from the pharmaceutical and medical device industries had a lot of questions.
- Of the four EUA declarations, three are specific to devices, and it’s not clear if the agency will withdraw those EUAs all at once or at different times.
- The webinar did not offer stakeholders a clear answer on whether HHS issues the advance notice on withdrawing the EUA declarations first, or FDA will finalize its two guidance documents on its transition plans. Instead, FDA staff told attendees that whatever happens first depends on the course of the pandemic. If hospitalizations continue to decline and stay low, HHS may pull the EUA declarations first; otherwise, finalization of the guidance documents could come sooner.
- The FDA says more guidance is on the way, but it’s unknown when it will be released. According to FDA staff, this would pertain to the types of data FDA will consider when transitioning a drug product from an EUA to formal market access, such as how real-world evidence will be considered.
While pharmaceutical industry stakeholders can feel relieved that EUAs won’t expire with the end of the PHE and that the FDA is making plans for a post-pandemic world, question about what that world will look like simply add to the narrative that the federal government’s take on health care policies once the PHE ends need significant refinement.