FDA announces new Coronavirus Treatment Acceleration Program

April 3, 2020

Blog Post

On March 31, the U.S. FDA announced a new program, known as the Coronavirus Treatment Acceleration Program (CTAP), focused on bringing new therapies to sick patients as quickly as possible, while supporting research to ensure safety and efficacy of new treatments and countermeasures. The program aims to streamline and coordinate efforts in both the public and private sectors to bring coronavirus treatments to market.

As part of the program, FDA is redeploying staff, including from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, to provide regulatory advice, guidance and technical assistance as quickly as possible. FDA also indicates that it is “triaging requests from developers and scientists seeking to develop new drug and biologic therapies” in order to put them in touch with the relevant FDA staff to provide “rapid, interactive input to get studies underway quickly.” For example, the FDA has reviewed study protocols within 24 hours in many cases and has reviewed single-patient expanded access requests generally within three hours.

FDA stresses that it is “committed to maximizing [its] regulatory flexibility” and that “[a]ccelerating the investigation of products that could potentially benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities.” To that end, FDA has also provided resources to healthcare providers and researchers to help them submit emergency requests to use investigational products for patients with COVID-19 infections.

As of March 31, FDA had guided 10 therapeutic agents into active trials and was overseeing another15 therapeutic agents in planning stages. Current therapeutic areas being evaluated include antiviral drugs like remdesivir that might treat the specific virus, and interleukin-6 (IL-6) receptor inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients. Additionally, convalescent plasma and hyperimmune globulin (antibody-rich blood products that are taken from blood donated by people who have recovered from the virus) are under investigation for their potential to shorten the length or lessen the severity of the illness. Existing therapies such as chloroquine and hydroxychloroquine (with or without other medications) area also being evaluated.

Over the past 24 months, the U.S. Department of Health and Human Services Office for Civil Rights has brought notable enforcement efforts against several non-profit covered entities and business associates, resulting in instances of six and seven-figure penalties against providers across the county for incidents involving breaches of protected health information.

A new amendment to New York state law, which would have required all healthcare providers to obtain separate consents from patients for treatment and payment is on hold until further guidance is released, according to the New York Department of Health.

On November 1, 2024, the Centers for Medicare & Medicaid Services issued the Medicare Physician Fee Schedule 2025 final rule, which establishes new advanced primary care management billing codes that will expand opportunities for physician practices, federally qualified health centers, rural health clinics and other health care providers to get paid for services provided by clinical staff under the direction of a physician, nurse practitioner or physician assistant beginning January 1, 2025.

FDA announces new Coronavirus Treatment Acceleration Program

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