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The U.S. Food and Drug Administration (FDA) announced a new program today that’s designed to foster close collaboration between public and private organizations in order to “bring coronavirus treatments to market as fast as possible,” according to U.S. Department of Health & Human Services Secretary Alex Azar in a press release. The program, dubbed the “Coronavirus Treatment Acceleration Program,” or CTAP, will see the FDA redeploy resources and personnel with an eye toward providing private companies, researchers and scientists with “regulatory advice, guidance and technical assistance as quickly as possible.”
Based on the information provided by the agency, it sounds like CTAP is a formalization of a lot of the work that was already being done within the FDA to reduce the burden placed on companies and scientists looking to field trials and the steps required by the administration to qualify new treatments and therapies for use.
In real-world terms, the FDA says that means it’s turning things around much more quickly, reviewing protocols for many freshly submitted clinical studies within 24 hours, and also turning around single-patient requests for expanded access to some therapies granted under compassionate or investigate use “generally within three hours.” The FDA is also looking at how it can build out streamlined protocols that can apply across use by different institutions and for different programs wherever possible to further limit processing time through templated strategies.
Internally, the FDA has re-arranged staffing resources to help make this possible, putting medical and regulatory staff that otherwise would be focused elsewhere on teams dedicated to COVID-19-related reviews.
There’s likely to be some debate about the implications of the introduction of a program like this. On the one hand, it should help novel approaches and even startups in the biotech space with unproven, but promising technologies in development to work hand-in-hand with the FDA on potential solutions. On the other hand, the administration has already been criticized for some of its more aggressive decisions regarding COVID-19 therapeutics, including the Emergency Use Authorization ordered for anti-malarial hydroxychlroquine earlier this week.
While small-scale studies have shown that the drug could offer some benefit in the treatment of COVID-19 patients, the key word there is “could,” and other small-scale studies have shown that standard anti-viral treatments are just as effective. The bottom line is that there isn’t enough data available to say anything definitively either way, and this particular EUA means that efforts to stockpile the drug could make it less available to those who use it for another of its common purposes: treating chronic rheumatoid arthritis, which can be debilitating in its severity.
The current coronavirus pandemic is unprecedented in terms of its spread and impact, at least in terms of viral outbreaks during the modern medical era. The FDA definitely needs to address the situation in a unique manner as a result, but critics and observers will definitely be watching to see what results from increased pressure on the agency to cut red tape.