How did the U.S. government only manage to produce a fraction as many testing kits as its peer countries? There have been three major regulatory barriers so far to scaling up testing by public labs and private companies: 1) obtaining an Emergency Use Authorization (EUA); 2) being certified to perform high-complexity testing consistent with requirements under Clinical Laboratory Improvement Amendments (CLIA); and 3) complying with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Common Rule related to the protection of human research subjects. One the demand side, narrow restrictions on who qualified for testing prevented the U.S. from adequately using what capacity it did have.

It’s important to understand the broader context of the FDA regulatory process. It often takes more than a decade for a new diagnostic test or therapeutic drug to earn FDA approval. Fortunately, the FDA already has the ability to let public labs and private companies circumvent the regular approval process under its Emergency Use Authorization (EUA) authority. So, why was this emergency authority ineffective in scaling up coronavirus testing? Here is a timeline of the most important events…