This Is How FDA Can Develop Faster Testing During Coronavirus Outbreak
Crowdsource Innovation
A company’s success is not entirely attributed to the performance of the founder, but the value creation for the user. The same can be said for coronavirus testing in the United States.
The first coronavirus disease (COVID-19) case in the U.S. and South Korea was detected on January 21. South Korea immediately increased widespread testing while the U.S. Food and Drug Administration (FDA) blundered. Alec Stapps’, Director of Technology Policy at the Progressive Policy Institute, “Timeline: The Regulations — and Regulators — That Delayed Coronavirus Testing,” outlines three significant regulatory barriers to scaling up testing:
- Obtaining an Emergency Use Authorization (EUA)
- Being certified for high-complexity testing under Clinical Laboratory Improvement Amendments (CLIA)
- Complying with HIPAA Privacy Rule and the Common Rule related to the protection of human research subjects
Laboratories that were already conducting their own tests needed to cease operations until they were granted a EUA. On February 4, the FDA issued a single EUA to the Centers for Disease Control and Prevention (CDC). By doing this, the FDA “put all its eggs in one basket.” But then the CDC…
