On February 23, 2022, the Administration published in the Federal Register a Notice of “Continuation of the National Emergency Concerning Coronavirus Disease 2019 (COVID-19) Pandemic” to extend the national emergency declaration from March 13, 2020. The 2020 Declaration was due to expire on March 1, 2022 and, with this Administrative Order, the national emergency continues, without a specific termination date. Extending the national emergency would seem to be counter-intuitive given that many States and localities are easing restrictions and the Centers for Disease Control and Prevention (CDC) is reporting decreasing rates and risks of COVID-19. However, numerous business, health, and government interests have asked for extension of the national emergency to minimize disruptions to patient care and allow for an orderly transition.
By way of review, under the national emergency declaration, agency leaders, such as the Secretary of Health and Human Services (HHS), are authorized to exercise authority to temporarily waive or modify certain federal requirements. With the emergency declaration in place, the United States Food and Drug Administration (FDA) was able to waive certain product approval standards and bring medical products swiftly to market through the issuance of Emergency Use Authorization (EUA). HHS has also waived certain privacy and other requirements to enable greater use of telehealth and the Centers for Medicare and Medicaid Services (CMS) have waived program requirements to ease burdens on healthcare providers. Enrollment in the Children’s Health Insurance Program and state Medicaid also surged with increased eligibility.
Under EUAs, the FDA has authorized vaccines, therapeutics, and medical devices, including, masks and other PPE, over-the-counter antigen test kits, ventilators, and blood purification devices. Further, thousands of EUA products, are in manufacturer inventory and on wholesale and retail shelves, and with healthcare providers. Without the national emergency declaration, these vaccines, therapeutics, medical devices, and products would all be without the appropriate approvals, registrations, clearances, and licenses required under the Federal Food, Drug & Cosmetic Act and would all become unlawful. Patient care and access to products could be disrupted. Without the emergency health declaration supporting FDA’s EUA, the vaccination of children over age 5 currently authorized under the Pfizer EUA would also be impermissible.
FDA has begun the lengthy process of transitioning products marketed under EUAs to the required approvals and clearances. For example, FDA has issued two guidances (here and here) on transitioning medical devices to full clearances and approvals. The agency has also lifted its previous enforcement discretion for hand sanitizer. FDA has also already worked to approve the Pfizer-BioNTech COVID-19 vaccine (now marketed as Comirnaty) and the Moderna COVID-19 vaccine (now marked as Spikevax) and transitioning them from EUA status to full approval.
In early February, the Federation of American Hospitals was one of many groups to write letters to the HHS Secretary asking for assurances that the national emergency declaration would not be lifted without at least a 60-day notice. The Federation letter stated that the emergency declaration “continues to provide substantial flexibilities that are essential to ensuring [their] ability to care for both COVID-19 and non-COVID-19 patients alike…” The Federation wanted to ensure also that when the emergency declaration is eventually ended, 60-days’ notice is given to states and health care providers in order to unwind “the complex web of [emergency] waiver-authorized operations, programs, and procedures – which will have been in place and relied on for more than two years.”
This unwinding and transition from national emergency and global pandemic to “regular business” will be a significant undertaking for private industry, healthcare providers, and state and local governments. A little more time seems prudent to assure an orderly process for stakeholders and patients.
OFW Law will continue to monitor the national state of emergency and other COVID-19 developments. Please contact us if you have further questions.