On March 31, Health & Human Services Secretary Alex Azar announced the creation of a new FDA program, the Coronavirus Treatment Acceleration Program (“CTAP”), designed to speed up the development of life-saving treatments that have the potential to be both safe and effective.
Secretary Azar presented this new program as a new public-private cooperation that would involve redeploying medical and regulatory staff, including those from CDER and CBER, and greatly expediting the review process for requests from scientists and corporations developing new therapies. FDA staff would be tasked to provide regulatory advice, guidance and technical assistance as rapidly as possible. Examples of this streamlined process include the ultra-rapid review of study protocols, often within 24 hours, and round-the-clock review of single-patient expanded access requests, generally within three hours. In addition, FDA will immediately triage requests from scientists and other developers who want to develop or evaluate new drug and biologic therapies, with the appropriate FDA staff member generally responding to the request within one day.
Among the therapies currently being evaluated are:
- Antiviral drugs such as Gilead’s remdesivir (originally developed to counteract the Ebola virus).
- Interleukin-6 (IL-6) receptor inhibitors that may help reduce inflammation in the lung and improve lung function. (Note, however, that an opinion piece by Kalil published online on March 24 in the Journal of the American Medical Association cautions against the use of IL-6 inhibitors – already administered to patients in several other countries – due to “substantial evidence of potential harm.”)
- Convalescent plasma (see prior Alert) and hyperimmune globulin, both sourced from the blood of completely recovered COVID-19 patient volunteers.
- Antimalarial drugs hydroxychloroquine and chloroquine (see prior Alert).
As of March 31, FDA noted 10 therapeutic agents in active trials and another 15 in the planning stages.
In order to facilitate development of promising therapies, FDA’s focus will be on the generation of data from the randomized, controlled clinical trials that are required before full approval can be granted.
Diagnostic Test Update
Also on March 31, FDA announced that it has been working with over 220 novel coronavirus test developers that have indicated they will be submitting requests for Emergency Use Authorizations (EUA). By March 30, FDA had issued 22 such EUAs. In addition, more than 110 laboratories have begun testing in accordance with FDA’s COVID-19 Policy for Diagnostic Tests.