The Regulations—and Regulators—That Delayed Coronavirus Testing

Very good article on the timeline of mistakes.

Unfortunately, the United States has not made testing widely available and now various regions are being forced to impose severe economic and social lockdowns. As of March 17, the U.S. had tested only about 125 people per million. South Korea had tested more than 5,000 people per million. Between early February and mid-March, the U.S. lost six crucial weeks because regulators stuck to rigid regulations instead of adapting as new information came in. While these rules might have made sense in normal times, they proved disastrous in a pandemic.

Under ordinary circumstances, the cost of using an imperfect diagnostic test often outweighs the benefit. But when public health officials need to contain a novel and highly contagious disease, speed matters more than perfection. The lessons from this debacle are clear: The FDA needs to have plans in place prior to a pandemic for public labs and private companies to produce their own test kits. A distributed strategy would be much more resilient to errors, in contrast to the single point of failure created by the FDA in this crisis. Poor planning and mindless adherence to peacetime regulations led to this abysmal result:

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. On the demand side, narrow restrictions on who qualified for testing prevented the U.S. from adequately using what capacity it did have. LINK