The U.S. Food and Drug Administration (FDA) on Tuesday announced a new plan to promote close cooperation between public and private organizations,media outlet TechCrunch reported. According to a statement from U.S. Secretary of Health and Human Services Alex Azhar, the new program “will bring new coronavirus treatment as quickly as possible.” The program, known as the Coronary Virus Treatment Acceleration Program (CTAP), will allow the FDA to redeploy resources and personnel to provide “regulatory advice, guidance and technical assistance” to private companies, researchers and scientists as soon as possible.
According to the agency, It sounds like CTAP is a formal form of much of the work that has been done within the FDA to ease the burden on companies and scientists who want to conduct on-site trials, as well as the steps required by the authorities to make new therapies and therapies eligible for use.
In the real world, the FDA says this means it can turn things around more quickly, reviewing many newly submitted clinical studies within 24 hours, and reversing requests from single patients to expand the use of certain therapies they receive with compassion or investigation, which is typically used within three hours. The FDA is also looking into how to establish simplified protocols that can be applied to different agencies and for different programs to further limit processing time through templated strategies. Internally, the FDA has reassigned staffing resources to help achieve this, allowing medical and regulatory staff to focus on other review panels related to COVID-19.
There may be some debate about the implications of introducing such a plan. On the one hand, it should work with the FDA on potential solutions with unproven but promising technologies that help novel ways in biotechnology, and even start-ups. On the other hand, the U.S. government has been criticized for some of its more aggressive decisions on COVID-19 treatments, including an emergency use authorization to order the antimalarial drug hydroxychloroquine earlier this week.
While small-scale studies have shown that the drug can provide some benefits in treating PATIENTs with COVID-19, other small-scale studies have shown that standard antiviral treatments are equally effective. Most importantly, there is not enough data to say anything clearly in any way, and this particular EUA means that working on a drug stock may reduce its use for those who use it for another common purpose: treating chronic rheumatoid arthritis, which can be debilitating.
In terms of its spread and impact, the current pandemic of the new coronavirus is unprecedented, at least in terms of the outbreak of the virus in the modern medical age. Therefore, the FDA absolutely needs to address this situation in a unique way.