Since the advent of the COVID-19 pandemic, many governmental agencies and public health officials around the world have worked tirelessly to protect public health. Joining other federal, state, and local agencies, the U.S. Food and Drug Administration (FDA) has played a pivotal role in many aspects of the public health response to the pandemic, including producing guidelines, creating and updating policies, and issuing guidance documents to communicate these changes. In the FDA’s “COVID-19 Response, At-A-Glance Summary as of July 23, 2020,” the agency highlights its current areas of focus: the widespread availability of reliable COVID-19 testing and effective treatments.
Advancing the Timely, Widespread Availability of Accurate, Reliable Testing for COVID-19
Widespread COVID-19 testing helps public health authorities get a clearer picture of the scope of the outbreak in specific areas and take action to prevent the virus from spreading. The FDA is working to increase the availability of tests and testing materials through the use of the Emergency Use Authorization (EUA) authority.
Using this authority, the FDA may “allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.” Several steps must take place before an EUA may be issued, including a declaration of emergency or threat justifying emergency use by the Secretary of Health and Human Services. When the emergency ends, the EUAs issued in response to the emergency are terminated. In addition, the FDA may revise or revoke an EUA during an emergency if necessary.
As of July 23, 2020, the FDA has authorized 187 tests under EUAs in response to the COVID-19 emergency:
- 154 molecular tests
- 31 antibody tests
- 2 antigen tests
As the scientific community is constantly learning new things about SARS-CoV-2, the FDA may revise or terminate any of these EUAs in response to new evidence or if it becomes clear that the benefits of the test no longer outweigh its risks. On the FDA website, you can review which tests have been issued EUAs.
Expediting the Availability of Medical Equipment and Products That Treat COVID-19
The FDA is also issuing EUAs to help ensure the availability of essential medical equipment and products used in the treatment of COVID-19, including 85 ventilators and accessories. These devices play a critical role in the treatment of COVID-19 patients experiencing severe respiratory symptoms by mechanically controlling or supporting the patient’s breathing. In addition, the FDA has aimed to increase the accessibility of personal protective equipment (PPE) – respirators, gowns, surgical masks, face shields, etc. – through the issuance of EUAs and policies. On the FDA’s website, you can view the most recent final guidance documents related to PPE.
To address new possible therapies for coronavirus, the FDA created a special emergency program known as the Coronavirus Treatment Acceleration Program (CTAP). CTAP uses “every available method” to fast-track viable therapies, making them available for patients as swiftly as possible while still assessing their safety and effectiveness. As of July 14, 2020, the FDA has reviewed more than 230 trials of potential COVID-19 therapies, and more than 510 drug development programs for COVID-19 therapies are currently in the planning stages.
In addition to these two major focus areas, the FDA has also been (1) monitoring medical product and food supply chains to address imbalances and ensure safe distribution and (2) identifying and neutralizing medical products with fraudulent claims related to COVID-19, amongst other actions.
To keep up with coronavirus-related updates issued by the FDA, bookmark their COVID-19-Related Guidance Documents page.
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