The U.S. Food and Drug Administration (FDA) recently issued two guidance documents outlining the agency's expectations for COVID-19 drug development. The first guidance, "COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products," outlines a process for sponsors to receive agency feedback on supporting data with the goal of starting clinical trials as soon as possible. As the drug approval process is lengthy and complex, the guidance provides a helpful distillation of considerations particular to COVID-19. This includes clarity on the types of data and information required by the FDA to address clinical, nonclinical, and quality considerations, and how the data and information should be presented to the agency. The guidance is expected to result in more robust and streamlined applications to commence clinical trials, which can only commence after the FDA reviews an Investigational New Drug Application (IND) and is satisfied with the information contained in the application.

The second guidance, "COVID-19: Developing Drugs and Biological Products for Treatment or Prevention," provides the FDA's recommendations on later-stage clinical trials intended to establish safety and effectiveness for COVID-19 products. The document outlines important COVID-19 considerations in the context of established trial issues such as population, trial design, efficacy endpoints, safety considerations, and statistical considerations. The guidance also discusses the concept of a disease severity metric and provides examples of severity criteria. Adequately addressing these considerations is likely critical to successfully developing and commercializing a COVID-19 drug.

These guidances represent just one piece of the FDA's multifaceted approach to addressing drug development targeted to the COVID-19 pandemic. Among other components, the approach includes the Coronavirus Treatment Accelerated Program (CTAP) and methods to reduce regulatory burden to market. The CTAP involves a dedicated FDA team who is tasked with reviewing regulatory submissions with representation from senior management. Under this concentrated program, the FDA intends to provide rapid input on drug development plans and study protocols, prioritizing products with the greatest scientific merit. The agency's efforts to reduce premarket regulatory burden for COVID-19-related products have been comprised largely of Emergency Use Authorizations (EUAs) and deregulatory guidance documents that focus on applying enforcement discretion. But the CTAP, EUAs, and deregulatory guidances are generally intended to be active only during the COVID-19 public health emergency. Products commercialized through the drug approval pathway detailed in the recent guidances, however, will presumably remain on the market beyond the COVID-19 pandemic.

The recent guidances are viewed as a tool for both industry and the FDA to effectively manage COVID-19 products through the lengthy regulatory approval process. The FDA reports that so far, more than 130 clinical trials of potential COVID-19 related drugs and biological products are underway with FDA oversight, and additional development programs for other agents are in the planning stages. Given this pressure on agency resources, policies like those issued in the recent guidances are expected to provide more predictability, efficiency, and hopefully get COVID-19 drugs to market quicker.