What is the FDA Approval Process from Licensure or Clearance After an EUA? And How Does BARDA Fit-in?

What must happen for a medical product to get FDA approval, licensure or clearance after an EUA?

Unlike other regulatory actions for marketing, an EUA authorizes emergency use of the product for specific emergency circumstances when certain criteria are met, based on a reasonable belief that the product may be effective and the benefits of its use outweigh its risks under the circumstances. The amount of evidence needed to support the “may be effective” standard varies depending on the emergency circumstances, what is already known about the product, and the product type. For more information, see FDA’s guidance on Emergency Use Authorization of Medical Products and Related Authorities. During the COVID-19 response, FDA published guidance documents and templates to provide recommendations regarding the data and information needed to support issuances of EUAs.

FDA expects Sponsors to ultimately seek approval of their medical product, as EUA is not a regulatory mechanism and should not be the end goal in product development. As with all regulatory products, FDA provides Sponsors with guidance on the scientific and regulatory steps needed for approval, licensure or clearance, which will vary based on the product type, the intended use, and the product-specific data and information already submitted to FDA prior to issuance and during the course of its authorization.

What is BARDA’s role in designing and conducting clinical research for products that become candidates for EUA?

Conducting clinical trials is difficult, especially during a public health emergency. BARDA experts help private sector and academic partners design and conduct clinical trials that can support EUAs and applications for approval or licensure. Toxicologists, biologists, physicians, statisticians and other BARDA subject matter experts use their scientific, regulatory and industry experience to guide BARDA’s partners as they develop medical countermeasures for use in public health emergencies. BARDA also connects partners with core services they may need: networks of organizations with expertise in managing nonclinical studies and clinical trials, and a fill-finish manufacturing network.

What impact does BARDA have on the EUA process?

As part of the U.S. government, BARDA coordinates with other federal agencies, to prioritize the funding of the most promising candidates from academia and industry for emergency use. Once funded and to ensure readiness, BARDA and FDA work together prior to an emergency situation through “pre-EUA” submissions. BARDA subject matter experts also provide technical advice to industry partners preparing to submit EUAs and, in some instances, BARDA experts author and submit EUAs directly. BARDA Regulatory and Quality Assurance Division works closely with the FDA under a memorandum of understanding to facilitate the EUA process for our partners and ensure alignment on US government distribution and administration needs.

What’s the difference between BARDA’s role and FDA’s role in EUA process?

FDA is the regulatory agency that has the authority to issue EUAs. BARDA supports the advanced development of products that may be eligible for EUAs and can purchase products that have EUAs for distribution to the public during public health emergencies. EUAs may be sponsored either by a private company or BARDA on behalf of the US government. Although BARDA and FDA work closely together to help medical countermeasure developers understand regulatory requirements and pathways, the review of EUA for issuance is under FDA’s purview.

BARDA’s Regulatory and Quality Assurance Division is a team of subject matter experts that routinely assists our partners; their support ranges from helping partners submit INDs to the FDA to conducting Quality Assurance audits on investigational products BARDA purchases for national preparedness.

How do you conduct clinical research on a faster pace without cutting corners on safety?

Clinical trials can be conducted on an accelerated pace when there is collaboration, communication and clarity. We call this the Three Cs:

• Collaboration is important because multiple federal agencies must be involved and work together with private industry and other partners to ensure clinical trials are conducted efficiently. For example, a clinical trial network with a well-designed master protocol will allow many therapeutic candidates to be tested simultaneously.
• Communication across all of the collaborators is essential to enable the partners to work together to rapidly present the clinical trial data efficiently to the FDA for review.
• Clarity comes into play when the clinical trial data and other information is compiled and submitted for FDA review. Publicly posting information on FDA requirements and rational for approvals helps developers to make better decisions.

When you prepare for the next clinical trial while the previous one is still underway and when you undertake clinical trials and manufacturing work in parallel – instead of sequentially – you are able to make products available at a much faster pace while maintaining a high degree of confidence in product safety.