The U.S. Food and Drug Administration is expediting the development of novel therapies for the pandemic through an accelerated evaluation process.
With dire predictions of the possibility of more than 100,000 deaths from COVID-19 in the United States, the U.S. Food and Drug Administration (FDA) is expediting the development of novel therapies for the pandemic through an accelerated evaluation process.
The new program, known as the Coronavirus Treatment Acceleration Program, will use all tools available to the agency to bring new therapies as quickly as possible while continuing to support clinical research evaluating the medications against the disease. As an example, earlier this week the FDA approved malaria drugs hydroxychloroquine and chloroquine under Emergency Use Authorization as a treatment for the disease. The regulatory agency also expedited the use of convalescent plasma treatment for COVID-19 Patients. The FDA announced a new guidance last week suggesting it is possible that the treatment could be effective against the infection. The FDA has also approved multiple diagnostic tools aimed at COVID-19 under EUA, such as Abbott’s point-of-care test that can identify the novel coronavirus within five minutes.
Health and Human Services Secretary Alex Azar said as the number of COVID-19 diagnoses rises in the United States, the FDA is “cutting red tape” and moving as swiftly as possible to review requests from companies and researchers who are working on potential therapies. To support the expedited pace that is necessary to address the pandemic, the FDA said it is triaging requests” from those who are developing new drugs and biologic therapies. The FDA said it has review study protocols within 24 hours of receiving them, and, in many cases, has reviewed single-patient expanded access requests generally within three hours. The FDA said it is also collaborating with federal partners, developers and researchers to create protocols that can be used across institutions and programs to streamline efforts.
To support these goals, the FDA has, among other things, redeployed medical and regulatory staff to serve on review teams dedicated to COVID-19 therapies, streamlined processes and operations for developers and scientists to send inquiries and requests and provided resources to health care providers and researchers to help them submit emergency requests to use investigational products.
“We are also looking at pragmatic and expedited ways to make these products available to patients, while still ensuring the FDA’s standards are met,” FDA Commissioner Stephen M. Hahn said in a statement. “Accelerating the investigation of products that could potentially benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. 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.”
The FDA said it will continue to “enhance and expand its work” across the federal government, academia and the pharmaceutical industry to accelerate COVID-19 treatments and other medical countermeasures. The agency will outline additional information in the near future to provide a greater understanding of the full breadth of work in this area, to the extent permitted by confidentiality laws.
