On March 31, the U.S. Food and Drug Administration (FDA) launched a new program called the Coronary Virus Acceleration Treatment Program (CTAP), which aims to promote close collaboration between public organizations and private companies to bring potential treatments for new coronaviruses to market as soon as possible.
The new plan says the FDA will reduce unnecessary red tape and redeploy FDA resources and personnel to review treatment options for new coronaviruses provided by private companies, researchers and scientists as soon as possible, and provide regulatory advice, guidance and technical assistance.
From the FDA press release, the FDA is using all the methods and tools available to the agency to provide new treatments to new corona patients as quickly as possible, while reducing the burden on companies and researchers and speeding up assessments of the safety of new treatments.
The FDA says many companies and researchers are now developing and evaluating treatments related to the new coronavirus. Given the urgency of the outbreak, under the FDA’s accelerator program, staff at the Drug Assessment and Research Center, the Biologics Assessment and Research Center will provide regulatory advice, guidance and technical assistance as soon as possible.
As part of the program, the FDA categorizes and contacts relevant people to provide quick, interactive information to enable research to proceed quickly, in response to different requirements for the development of new drugs and biotherapies. For example, in most cases, the FDA reviews the research program within 24 hours and within 3 hours the individual’s request. In addition, the FDA works with U.S. federal partners, developers, and researchers to create simplified protocols that can be used in organizations to simplify work and further limit processing time.
“Accelerating the review of treatments and products that may be useful for new coronaviruses is one of the FDA’s top priorities,” FDA Commissioner Stephen M. Hahn said. We want to accelerate the need to help patients with promising treatments, to maximize our regulatory flexibility, and to bring together the best innovators to ensure that we deliver the right treatment for the right patients at the right time. “
The FDA’s plan has caused controversy, although it hopes to speed up the deployment of potential treatment programs. Some U.S. media have pointed out that the FDA should have worked with start-ups on potential and promising treatments. On the other hand, some of the FDA’s practices have been accused of being too drastic. For example, the FDA has previously issued an emergency use warrant for hydroxychloroquine and chloroquine. While there is limited evidence of the efficacy of chloroquine or hydroxychloroquine against the new coronavirus, the FDA says the benefits of these drugs outweigh the risks. Currently, the two antimalarial drugs are being used in the United States to treat the new coronavirus, which is being vigorously promoted by Trump.
At present, the United States has become the world’s largest number of confirmed cases of new coronary pneumonia, a cumulative total of more than 80,000 cases, up to 187,321 cases.