The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. The Coronavirus Treatment Acceleration Program (CTAP) is intended to promote collaboration between FDA, companies, scientists, and doctors to “bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.” One key element of the new program is FDA’s commitment to significantly expedited review and response times. Although it’s impossible to know the real-world impact, given the variations in facts and ever-changing environment, this announcement should be expected to provide processes that are clearer and faster progress for COVID-19 products.

Explaining the agency’s perspective and goals, FDA Commissioner Stephen Hahn said,“We want to help patients by expediting promising treatments and are committed to maximizing our regulatory flexibility and proactively bringing the best innovators together to ensure we are getting the right treatments to the right patients at the right time.” Examples of what FDA is doing as part of the CTAP include: 

-Providing ultra-rapid protocol review and interactive input on development plans – within 24 hours of submission, in many cases. 

-Completing review of single patient expanded access requests around-the-clock – and generally within 3 hours. 

-Working closely with applicants and other regulatory agencies to expedite quality assessments for products to treat COVID-19 patients and to transfer manufacturing to alternative or new sites to avoid supply disruption. 

-Advancing relationships with partners in the public and private sectors to rapidly collect and analyze information from different real-world data sources and clinical studies in areas such as illness patterns and treatment outcomes. 

According to the agency, its efforts to expedite have led to there being 10 therapeutic agents in active trials and 15 more in planning stages. 

Essential to the program’s success is FDA’s commitment to: 

-Redeploy medical and regulatory staff to dedicated COVID-19 review teams. 

-Redeploy medical, operations, and policy staff to support the overall effort. 

-Involve senior management in review of submissions. 

-Streamline processes and operations for developers and scientists to send the agency inquiries and requests. 

-Provide resources to health care providers and researchers to help them submit emergency requests to use investigational products for patients with COVID-19 infections. 

Of note, FDA stated that they will continue to enhance and expand the CTAP, and will share information with the public, including summaries of drugs in clinical and preclinical development, to the extent allowed under confidentiality laws. 

If you have any questions about expedited FDA programs for potential COVID-19 treatments, or pandemic-specific agency policy more generally, please contact your Hogan Lovells attorney.   

Authored by Philip Katz, Lynn Mehler, Jim Johnson, Heidi Gertner, and Susan Lee