CPhI Online

FDA launches programme to speed up development of COVID-19 treatments

1 Apr 2020

The US Food and Drug Administration said Tuesday it is “using every tool at the agency’s disposal” with the launch of a new program to speed up the development of treatments for patients with COVID-19.

As of March 31, the US had the highest number of confirmed cases of coronavirus in the world with 189,399 reported while the country’s death toll from the pandemic surged past 4,000 on the same day.

The Coronavirus Treatment Acceleration Program (CTAP) has the twin aim of bringing medicines to sick patients infected with COVID-19 as quickly as possible while at the same time supporting research to further evaluate whether they are safe and effective for treating infected patients.

“The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible,” said Department of Health and Human Services Secretary Alex Azar. “As part of this new program, 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. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of HHS to support potential coronavirus treatments for weeks now.”

The FDA said that given the large number of companies and researchers developing and evaluating COVID-19 related therapies and the urgent nature of the pandemic, under the CTAP, staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance as quickly as possible.

“As part of this work, the FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly,” the FDA said.

It added that it has reviewed study protocols within 24 hours in many cases and single-patient expanded access requests within three hours and is also collaborating with federal partners, developers and researchers to create cross-institution protocols and programmes.

“Accelerating the investigation of products that could potentially benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities,” said FDA Commissioner Stephen Hahn.

On March 28, the FDA issued an Emergency Use Authorization (EUA) to allow 30 million doses of hydroxychloroquine sulfate and chloroquine phosphate products donated by pharma companies Sandoz -- Novartis’s generics unit -- and Bayer to the Strategic National Stockpile(SNS) to be distributed and used for certain hospitalized patients with COVID-19.