FDA special emergency program will accelerate COVID-19 therapies

As the COVID-19 pandemic spreads rapidly throughout the world, the urgency of finding a treatment has magnified. The Coronavirus Treatment Acceleration Program (CTAP), a special emergency program created by the Food and Drug Administration (FDA), will accelerate COVID-19 therapies by using all available methods to rapidly deliver new treatments to patients, says GlobalData, a leading data and analytics company.

CTAP seeks to triage requests from scientists and developers so that the FDA can get in touch with them quickly and get them connected with the right staff. The FDA’s aim is to respond within one day after the initial round of requests. Development plans will receive ultra-rapid input with prioritization based on the merits of the project and the stage of development. Protocols will also be reviewed in an ultra-rapid 24-hour timeframe. Reviews of single patient expanded access will aim to be completed within three hours. Quality assessments for COVID-19 treatments will be expedited and analyzed for transfers to alternative sites for manufacturing in order to avoid supply disruption.

Support will be provided to CTAP by redeploying medical and regulatory to dedicated COVID-19 therapy review teams. Medical, operations and policy staff will be redeployed to support the COVID-19 effort, whilst researchers and healthcare providers will be provided with resources for emergency requests to enable the use of investigational products for COVID-19 patients.

Johanna Swanson, Product Manager at GlobalData, comments: “The FDA is also working to advance relationships with partners in both the public and private sectors. This will allow the agency to more rapidly collect information on COVID-19 and analyze both patterns and treatment outcomes. Sharing more information across diverse sources could speed up the development of a treatment.

“CTAP has both positive and negative implications. It could reduce bureaucratic delays and get novel therapies and solutions implemented faster. On the other hand, it could also open up the administration for critique over aggressive decisions. Drug development is generally slow, cautious, and evidence based. Speeding it up could open it up to issues such as the focus on drugs with less evidence such as malarial ones and distract from other more promising treatments.”

More Media