Takeaways

As long as the COVID-related emergency is deemed to exist, fast-tracked FDA regulatory approvals, in the form of Emergency Use Authorizations, are a viable option for companies looking to commercialize new products that may serve a purpose in mitigating the effects of COVID.
On the other hand, FDA has indicated in the past few months that, barring a relapse in the fight against COVID, it will develop a transition plan toward requiring ordinary course approvals.
To avoid supply chain disruptions, companies should consider proactive strategies to determine whether to pursue EUAs instead of ordinary course approvals and, if they choose the former or have obtained an EUA already, whether they should also do the legwork at this moment to be able to obtain an ordinary course approval as swiftly as possible once (and if) the COVID emergency is lifted.

The coronavirus pandemic prompted an unprecedented reliance on Emergency Use Authorizations (EUA) by the Food & Drug Administration (FDA) for a variety of medical devices and treatments. During a public health emergency, the FDA can issue EUAs to “allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.”

Since the Secretary of the U.S. Department of Health and Human Services (HHS) declared that circumstances existed justifying emergency authorization of drugs and devices due to the pandemic in March 2020, FDA has issued hundreds of EUAs for medical devices as well as a lesser number for drug and biological therapeutic products used to diagnose, prevent, or treat COVID-19. These include the following currently active EUAs:

  • Three vaccines
  • 10 drug and biological therapeutical products
  • Four blood purification devices
  • Three continuous renal replacement therapy devices
  • 13 decontamination and bioburden reduction systems devices
  • One infusion pump device
  • Six remote or wearable patient monitoring devices
  • Six respiratory assist devices
  • More than 100 ventilators and ventilator accessories
  • More than 100 diagnostic tests
  • Dozens of surgical masks

However, as the nation emerges from the COVID-19 emergency, the regulatory landscape will shift. Companies increasingly will be required to obtain “ordinary course” approvals. That is, their products will be subject to more involved regulatory scrutiny before they are approved for use, and existing EUAs will be modified or revoked.

Emergency Use Authorizations

Authorized under Section 564(c) of the Federal Food, Drug, and Cosmetic Act (FFDCA), EUAs have been a tool for fast-tracking FDA approvals in the face of public health emergencies since 2004. Before the FDA can issue EUAs, the HHS Secretary must declare an emergency justifying authorization for emergency uses of products. Since the Secretary of HHS first issued a declaration on January 31, 2020 in response to the pandemic, this declaration has been extended five times, most recently on April 15, 2021. For the foreseeable future, the Secretary will very likely continue to extend this declaration, meaning FDA will retain its authority to issue EUAs.

For a sponsor to obtain an EUA, the following criteria must be met:

  • the product will be used for a serious or life-threatening disease of condition;
  • based on the totality of the scientific evidence available, it is reasonable to believe that the product will be effective and the potential benefits of the product outweigh the known and potential risks of the product;
  • there is no adequate FDA-approved alternative available; and
  • the product meets any other criteria established by the Secretary.

EUA Revocations

The FDA reviews EUAs continuously and may revoke EUAs when the criteria under section 564(b)(1) (declaration of an emergency) of the FDCA no longer exist, the criteria under section 564(c) (criteria for issuing an EUA) are no longer met, or other circumstances make revision or revocation appropriate to protect the public health or safety.

Even as the pandemic persists, FDA has revoked EUAs in light of new information and/or at the request of product manufacturers. In a memorable episode in 2020, FDA granted and subsequently revoked an EUA for hydroxychloroquine, a treatment touted by then-President Trump. Also in 2020, the FDA revoked EUAs for protective barrier enclosures and infusion pumps. More recently, in response to a request from a product manufacturer, FDA revoked an EUA granted for a COVID-19 therapy. FDA found that based on the available scientific evidence, the benefits of using of the therapy alone no longer outweighed the risks. Additional voluntary revocations may be forthcoming, as both Pfizer Inc. and BioNTech SE submitted Biologics License Applications with FDA in May 2021 as a first step towards receiving full FDA approval to market their COVID vaccines.

These examples demonstrate that the regulatory landscape is shifting as the bases for the EUAs become better understood and circumstances change. While recent EUA revocations were and, in the case of Pfizer’s and BioNTech’s vaccines, presumably will be voluntary, companies should anticipate the transition away from emergency conditions, which will require more regulatory oversight to obtain use approvals.

FDA Transition Plan to “Ordinary Course” Approvals

Even as regulatory oversight gradually reverts to more normal conditions, many EUAs will not be short-lived. Indeed, if past practices are any indication, “emergency conditions” will likely persist for a while yet, as evidenced by the prolonged Zika and Ebola emergencies. Indeed, at a May town hall, the FDA indicated that they do not expect the emergency to be declared over “anytime soon.” It is therefore possible, if not likely, that the COVID-19 state of emergency will persist for several years, and the relatively fast-tracked EUA approval process will remain a viable option.

At the same time, FDA indicated in an April town hall that it is working on a transition plan that may entail a gradual termination of certain COVID-19-related EUAs and decreasing reliance on EUAs, which may necessitate an increasing need to obtain “ordinary course” approvals for products that have been marketed through EUAs. For example, in a May town hall, the FDA indicated that while it is still accepting EUAs for antibody, molecular and antigen COVID-19 tests, its review priorities have shifted—and will likely continue to shift—toward tests that increase capacity or access, including tests for use at point of care and home collection. FDA has not qualified or rescinded these statements in light of the mounting concerns regarding the COVID Delta variant.

As a formal transition plan is developed, such shifting priorities within the FDA should be closely monitored to avoid supply chain disruptions, with the expectation that the relatively fast-tracked reviews that characterize EUAs may eventually be slowed by FDA prioritizing EUA reviews that fill the most pressing needs within the pandemic when the pandemic is viewed as a whole. Of course, the situation is complicated by current concerns suggesting the COVID Delta variant and shortcomings in achieving nationwide vaccination targets.

Conclusion

Nearly a year and a half into the pandemic, the medical industry and regulators have gained significant knowledge of COVID and how to effectively prevent and treat it and have necessarily deployed products to address the pandemic through EUAs. For the foreseeable future, EUAs will likely continue to be a viable option. However, COVID-19 treatment and device manufacturers and distributors should anticipate a gradual transition away from EUAs to “ordinary course” FDA approvals.

Obtaining FDA approval in the ordinary course for a product can be a costly and time-consuming process. To avoid supply chain disruptions, companies will have to develop proactive strategies to determine whether to pursue EUAs instead of ordinary course approvals and, if they choose the former or have obtained an EUA already, whether and when additional efforts should be taken to obtain an ordinary course approval.

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