emergency use authorization

What Does the End of the COVID Public Health Emergency Mean for Emergency Use Authorizations?

February 27, 2023

I remember listening to many predictions after the Department of Health and Human Services (HHS) issued the COVID-19 public health emergency Jan. 31, 2020. None of them included that it would last for more than three years!

But the time has come. The federal government has announced that the COVID-19 public health emergency (PHE) is set to end May 11 this year.

Along with more funding made available during the PHE to help ensure the health, safety and welfare of the public, we saw an important executive order. Issued under the Defense Production Act in May 2020, the order empowered the FDA to authorize the emergency use of unapproved medical products, or the unapproved use of an approved medical product.

The beginning: EUAs

With this emergency use declaration, a call went out to private industry to produce the supplies needed to respond to the COVID-19 pandemic: medical countermeasures including personal protective equipment (PPE), medical devices, diagnostic tests, therapeutics, and vaccines. In return, the FDA committed to streamline the reviews of safety and efficacy information through use of Emergency Use Authorizations (EUAs).

Scientific evidence is usually generated during clinical trials under an Investigational Device Exemption (IDE) for medical devices, or an Investigational New Drug (IND) application for pharmaceuticals/biologics. For EUAs, the FDA heavily scrutinized what safety data was available, then allowed products onto the market to help combat the ravaging effects of the pandemic based on the benefit-risk profile and the existing efficacy data.

In addition to self-reporting expectations regarding safety and/or efficacy issues, the FDA’s expectation was that generated data would be included in an eventual regulatory submission for clearance or approval after the PHE lifted – as is the case now.

It’s time…for traditional regulatory pathway clearance and approval

So where does this leave the manufacturers of PPE, medical devices, diagnostic tests, therapeutics, and vaccines that commercialized products through EUAs?

Companies that have products authorized for emergency use by the FDA will soon face the requirement for clearance or approval through traditional regulatory pathways, such as 510(k), de novo, PMA, NDA or BLA. Additionally, IDEs and INDs, to the extent clinical data is still needed, will also be required.

Some companies have already achieved clearance or approvals for their COVID-19 products through 510(k)s, de novos, PMAs, but those who have not should begin this transition if their intention is to remain on the U.S. market long-term.

While the PHE will lift May 11, existing EUA products and the FDA’s authority to continue issuing EUAs will remain in effect until the U.S. Department of Health and Human Services terminates the EUA declaration, separate and distinct from the PHE declaration. The Federal Register will publish notice of that termination. At that time, the transition will begin.

Transition for unapproved, approved products

Remembering that EUAs are currently in place for both unapproved products and approved products with unapproved uses, the transition will look different for each.

The FDA pledges “a sufficient period for proper dispositioning” for unapproved products, and “a sufficient period for proper dispositioning of any labeling or other materials associated with the authorization” for approved products with unapproved uses.

For approved products with unapproved uses actively being administered to a patient, “the EUA will remain effective even after termination of the EUA declaration or revocation of the EUA to provide for continued use with respect to a patient to whom it was administered while the declaration remained effective (to the extent found necessary by the patient’s physician).”

Next steps for manufacturers

The result of all this is that manufacturers of currently authorized COVID-19 products may be feeling some degree of panic. There’s no need. Keeping in mind that the PHE is set to end May 11, manufacturers should  stay up to date on notices published in the Federal Register after the EUA Declaration is lifted. Until then, current EUAs will remain in effect. Products would only be removed from the market if they do not secure clearance or approval from the FDA through the traditional regulatory pathways once the time for transition has expired.

As recent as January 31, the FDA affirmed its commitment “to providing timely recommendations and regulatory information to support response efforts,” and stated its intention to issue a Federal Register notice with any impact pertaining to its current COVID-19 related guidance documents. Otherwise, the agency did not indicate any immediate impact on its EUA activities.

Start your transition today

Manufacturers have the gift of time to get started with transition plans for their COVID-19 products. Getting regulatory affairs in order to remain on the market is critical, especially if Medicaid/Medicare reimbursement (which requires full compliance with FDA regulations for commercialization) is important to the bottom line.

Boulder iQ has the expertise to assist with regulatory transition strategies and the premarket applications for full compliance. Contact us today to learn what information and data will be expected for your COVID-19 product’s submission.

By Joanne Rupprecht, former Senior Vice President – Regulatory and Quality, Boulder iQ