 The delay in COVID-19 testing in the United States meant that for weeks doctors and public health officials were flying blind about who was infected and the location of major outbreaks. As a result, they had little hope of containing the virus before it started spreading out of control. Why did the US fall behind almost every other country in this regard? It's a long-standing problem that's led to needless suffering and loss of life long before the coronavirus pandemic. But in this case, its impact is so high-profile and far-reaching that the episode could finally bring lasting reform. Drastic measures being taken to try to contain the outbreak of a mysterious pneumonia-like virus. The genetic sequence for COVID-19 was published on January 10th by Chinese scientists and uploaded to the National Institute of Health's website, allowing laboratories around the world to create their own diagnostic tests. German scientists had one within a week and other countries in private labs quickly followed suit. The World Health Organization shipped 250,000 of the German version of the tests to labs around the world, but the US Center for Disease Control decided it needed to rely on its own version of the test, which would be certified by the Food and Drug Administration. But it wasn't ready until early February. February 6th and 7th, 90 tests were shipped to state public health labs around the country. But the kits had a technical flaw and needed to be returned to the CDC for testing. Meanwhile, the virus continued spreading. On February 4th, the FDA said it would allow government-approved labs with high complexity testing capabilities to create their own tests, provided they copy the CDC's approach and send all of their results to the agency's headquarters in Atlanta for verification. Former FDA Principal Deputy Commissioner Joshua Sharfstein told The New Yorker, you certainly wouldn't want to say any lab can advertise a coronavirus test, because then it's going to be chaos. There's a lot of people who will sell things that may or may not work. Though well-intentioned, the rule became a stumbling block. Every virus is a little different, but this is one of the most challenging ones, certainly I've seen in my lifetime. Take the case of Alex Greninger, a doctor and researcher at the University of Washington, who sent in his application to create a coronavirus test via email. According to a report in GQ, he then learned that he also needed to submit a paper copy. And then another version burned to a compact disc or loaded onto a drive and delivered to the FDA's Maryland headquarters. After he complied, according to a report in ProPublica, the FDA didn't approve his test right away. They asked him to make sure his test didn't cross-diagnose with SARS and MERS, other coronaviruses, which hadn't been seen in the U.S. in years. His test was finally certified on February 29th, at which point the fatal outbreak in his home state of Washington was already underway. As the crisis worsened and the testing shortage drew headlines, the FDA simplified the process. But then on March 20th, they warned that they may shut down efforts to rapidly make available at-home testing kits on the grounds that they were unvetted and could be fraudulent. The first documented cases of COVID-19 in the U.S. and South Korea were discovered around the same time. Yet as of March 17, one out of 4,300 Americans had been tested. In South Korea, it's one out of 17. Had diagnostic tests for COVID-19 been available sooner, they would have helped public health officials isolate, quarantine, and provide medical supplies to areas of the U.S. affected by the virus. How could this happen? This tragic testing delay has brought national attention to the FDA's long-standing, overly cautious approach to regulating American healthcare. To minimize risk, the agency has sacrificed speed, preventing doctors and patients from accessing the tools they need until it's too late. The agency's risk reduction over speed of approval goes back to the 1960s, when a sleeping pill called thalidomide marketed to pregnant women caused babies to die in utero or to be born with serious birth defects. The crisis was mostly contained to Europe because concerned FDA regulators had kept the untested drug out of the U.S. In 1962, President Kennedy signed a landmark bill increasing the agency's oversight powers. It resulted in a culture of extreme caution that led to long approval times for experimental drugs and devices, keeping potentially lifesaving tools out of the hands of patients. The beginning of the movement to relax those rules and rethink the trade-off between risk and speed in the FDA approval process began during the AIDS crisis of the 1980s. Gay rights activists were outraged that the FDA wouldn't quickly approve more experimental drugs like AZT, which blocks HIV's replication or thalidomide used to treat some of the wasting symptoms of AIDS. After lobbying and protests, including the 1988 shutdown of the FDA building, the administration slowly began to loosen its rules, leading to the approval of highly active antiretroviral therapy, or HART, in 1996, because of HART contracting HIV wasn't a death sentence anymore. Gay rights activism during the 1980s and 1990s created a framework for patient advocacy to people with life-threatening illnesses, leading to the Right to Try movement, which has allowed terminally ill patients to access experimental drugs and devices that are still undergoing FDA testing. The movement pushed the agency to streamline its own compassionate use program to help the same kinds of patients. But the COVID-19 testing debacle underscores the limits of those reforms. Once a full investigation comes out about the agency's failures, perhaps it will bring fundamental reform, at last giving Americans rapid access to potentially life-saving tools.