FDA creates program to speed up coronavirus therapies

Stephen Hahn
FDA Commissioner Stephen Hahn (MD Anderson Cancer Center)

The FDA has created an emergency program to accelerate the development of treatments for the novel coronavirus. By redeploying staff, the FDA thinks it can respond to COVID-19-related requests and review protocols within 24 hours of receipt as political pressure ramps up to speed along new therapies and vaccines.

As the COVID-19 pandemic has escalated, a growing number of drug developers have put their resources behind repurposed and novel therapies. The FDA now counts 10 drugs in active trials, with another 15 back at the planning stage. In trying to reduce regulatory barriers to the progress of those assets, the FDA has established processes it has now formalized with the creation of the Coronavirus Treatment Acceleration Program (CTAP).

The FDA said CTAP “uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.” In practice, that means developers of potential treatments for COVID-19 will benefit from an inside track at the FDA to shorten waits at multiple steps of the process.

In explaining the effects of CTAP, the FDA highlighted its ability to respond to requests from people developing COVID-19 candidates within 24 hours. The agency’s goal is to get “the right FDA staff in touch with them and the work to get studies going fast.” 

The FDA also cited 24-hour reviews of protocols and the processing of single patient expanded access requests within three hours as examples of CTAP in action. Other examples include the expediting of quality assessments and collaboration with companies and other agencies to transfer production to new sites to prevent disruption to supply.

Exactly how quickly the FDA will give companies what they need depends, in part, on assessments of the prospects of the development candidate. Specifically, the FDA is prioritizing interactions “based on a product’s scientific merits, stage of development and identification as a possible priority product.”

Even with that triaging of requests, CTAP has necessitated a reshuffle of FDA resources to deliver on the turnaround times. The FDA has redeployed medical and regulatory staff into teams focused on the coronavirus and tasked staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research with providing advice, guidance and technical assistance as quickly as possible.

“The FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies,” Department of Health and Human Services Secretary Alex Azar said in a statement.

This comes as the FDA is under pressure to get new or existing therapies into the hands of doctors to treat moderate to severe cases of COVID-19, with President Donald Trump and his attorney and former Mayor of New York Rudy Giuliani in the last week becoming more vocal about using existing drugs, or new ones, to help battle the disease as quickly as possible.