FDA, Industry Prepare for Post-EUA World

As the COVID-19 pandemic shows signs of becoming less widespread and lethal, federal agencies and medical product manufacturers are assessing the potential impact on the development and distribution of drugs and diagnostics made available under FDA’s Emergency Use Authorization (EUA) policy. That program has allowed FDA to approve medical countermeasures based on more limited clinical and manufacturing data to facilitate earlier patient access to treatments and preventives during the health emergency.¹

Although the Biden administration recently extended the current COVID public health emergency (PHE) declaration past its mid-April expiration date,² government agencies and the biomedical industry anticipate an end to emergency status in the near future. That prospect is prompting all parties to consider likely changes in R&D processes as well as in coverage and reimbursement for pandemic therapies, vaccines, diagnostics, and other medical products. FDA recently posted an information page on the topic, aptly titled “What happens to EUAs when a public health emergency ends?”³

FDA’s process for approving drugs, vaccines, and diagnostics under a health emergency is governed by section 564 of the Food, Drug, and Cosmetic Act and differs from the rules affecting federal health coverage and reimbursement under the Public Health Service Act.⁴ FDA initially gained EUA authority in 2004 to facilitate access to drugs, biologics, and diagnostics needed for emergency use, as in the case of an anthrax attack, the emergence of a deadly virus such as Ebola or Zika, and other bioterrorism events. EUAs related to those conditions have not been terminated and remain in effect, largely for a number of in vitro diagnostics (IVDs) and added uses for some therapeutics.

Specific authority for FDA to approve EUAs related to SARS-CoV-2 was issued by the secretary of Health and Human Services (HHS) in February 2020 to facilitate the availability and use of qualifying treatments lacking full market approval. This authority does not expire automatically as with other PHS emergency policies; it has enabled FDA to speed critical anti-COVID vaccines to the nation, while also issuing hundreds of EUAs for IVDs, ventilators, personal protective equipment, and other medical devices—most recently for a breathalyzer COVID diagnostic test.

EUAs have been more controversial for the handful of antivirals and monoclonal antibodies seeking that status. FDA has revoked emergency use for certain therapeutics later found less safe or effective than initially claimed, notably for hydroxychloroquine/chloroquine. More recently, the spread of the new Omicron BA.2 subvariant led to the revocation of the EUA for the mAb sotrovimab (Xevudy) produced by GlaxoSmithKline and Vir Biotechnology, based on its reduced effectiveness against the new strain.⁵ Similarly, in January FDA ended emergency use of Regeneron’s mAb REGEN-COV as a preventive and treatment for COVID due to lack of effectiveness against new variants. Regeneron, meanwhile, applied for full FDA approval of the therapy for preventing and treating COVID, but FDA recently extended its review of the application for three months (until July 13) to assess additional information to support a biologics license application (BLA).⁶

These regulatory actions illustrate the importance of manufacturers anticipating and planning for the conduct of studies needed for the eventual conversion of EUAs to full approvals. That process will tax FDA resources, particularly for the vast number of EUAs for medical devices; FDA recently proposed a 180-day period for manufacturers to either discontinue EUA product distribution or seek permanent marketing authorization for diagnostics and other products.⁷

Vaccine makers have taken the lead in filing for full FDA approval of COVID preventives, starting with Moderna and Pfizer shots for adults. Vaccines for younger age groups and booster shots continue to be provided under EUAs, although manufacturers have begun to seek permanent approval of added uses and indications. And while EUAs largely cover the full use of a medical product related to the pandemic, some already-approved therapies and medical products that gained expanded indications and uses under the emergency program will need to weigh whether to seek full approval of such added uses.

Limiting coverage

Although manufacturers may continue to produce and market drugs and vaccines under EUAs, an end to the broader HHS public health emergency will alter emergency coverage and reimbursement for numerous medical services, testing, and treatments. This will affect payment and access to therapies and vaccines through Medicaid and Medicare and state and local health programs and alter important flexibilities that now apply to private insurance and health care providers such as hospitals and clinics. Of particular importance will be the impact on the broader emergency use of telehealth programs, increased coverage for in-home care, the availability of free vaccinations and testing, and subsidies to access therapies at lower cost, as outlined in an issue brief from the Kaiser Family Foundation.⁸

In addition, a separate HHS declaration provides liability immunity for activities related to COVID countermeasure development and use. It protects pharmacists, physicians, nurses, and other providers who administer COVID vaccines, as well manufacturers and distributors involved in providing countermeasures to the nation. The end to that added immunity could affect access to treatments and diagnostics from biopharma companies and have notable implications for further development of medical countermeasures.

Jill Wechsler is Pharm Exec’s Washington Correspondent. She can be reached at jillwechsler7@gmail.com.

References

1. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covid19euas
2. https://aspr.hhs.gov/legal/PHE/Pages/COVID19-12Apr2022.aspx
3. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends
4. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
5. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization
6. https://investor.regeneron.com/news-releases/news-release-details/us-fda-extends-review-biologics-license-application-regen-covr
7. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-issued-emergency-use-authorizations-euas-during-coronavirus-disease
8. https://www.kff.org/coronavirus-covid-19/issue-brief/what-happens-when-covid-19-emergency-declarations-end-implications-for-coverage-costs-and-access/