Recent FDA actions and responses on COVID-19 pandemic

26-Jul-2021 - Last updated on 26-Jul-2021 at 15:41 GMT

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The US Food and Drug Administration has stayed on top of developments around the pandemic, including research into potential vaccines and treatments.

The drug development industry remains hard at work on treatments, tests, vaccines, and other solutions designed to help combat the COVID-19 pandemic. At the same time, the US Food and Drug Administration has kept its employees occupied with the review of such products, releasing of resources for industry professionals and civilians, and other coronavirus-related activity.

FDA’s plan of action

Acting FDA commissioner Janet Woodcock recently testified before the Senate Committee on Health, Education, Labor, and Pensions. Her testimony (in a hearing titled “The Path Forward: A Federal Perspective on the COVID-19 Response”) offered updates on the agency’s progress in numerous areas, as well as plans for response over the coming months.

OSP_FDA072621_JW — Janet Woodcock, acting commissioner, US Food and Drug Administration

“From the beginning of this public health emergency, FDA has taken an active leadership role in the all-of-government response to the COVID-19 pandemic, inspired by the resiliency of the American people and our great innovators,” Woodcock testified. “FDA stood up an internal cross-agency group that continues to ensure we are doing everything possible to protect the American public, help ensure the safety, efficacy, and quality of FDA-regulated medical products, and provide the industries we regulate with the guidance and tools to do the same.”

Her testimony touched upon:

Biologics and vaccines research, evaluation, and approval
Expediting of COVID-related clinical research
Expedited review of EUA requests
Work of the Coronavirus Treatment Acceleration Program (CTAP) to get therapies evaluated and approved as quickly as possible

Woodcock’s full Congressional testimony can be found here.

At-a-glance response summary

The FDA has updated its FDA COVID-19 Response At-A-Glance Summary document. The resource is intended to keep drug developers, researchers, healthcare providers, and civilians apprized on the actions taken and information issued by the agency.

The document includes information on:

Emergency use authorizations (EUAs) issued for COVID-19 tests; to date, 396 tests and sample-collection devices have received EUAs
Running tally of drugs currently being investigated as potential COVID-19 treatments—according to the FDA, there currently are more than 630 drug development programs in planning stages and 11 EUAs issued for COVID-19 treatments
Revisions and updates to patient-provider fact sheets on approved COVID-19 vaccines
Updates on drug shortages impacted by the pandemic.

Unauthorized COVID-19 consumer products

The FDA continues to monitor the sale and distribution of products to the public that are purported to prevent, treat, or cure COVID-19 infections. Companies recently issued warning letters for selling unapproved products include: