We're not ready for another pandemic

In March of last year, I explained that the U.S. was behind on coronavirus testing because the FDA’s authorization process for new types of lab tests—called an emergency use authorization, or EUA—was too slow. “The speed of this virus versus the speed of the FDA and the EUA process is mismatched,” Alex Greninger, the assistant director of the virology division at the University of Washington Medical Center, told me at the time. After these early testing bungles, the FDA changed its authorization process so that labs could spin up tests more quickly. But testing for Disease X is not guaranteed to go more smoothly. The FDA is answerable to whichever administration is in charge at the moment, and the next pandemic might happen under the watch of President Donald Trump Jr., not President Biden. A president might be incentivized to slow testing so that the overall rates of infection look better—and indeed, President Donald Trump reportedly did this. Another challenge that labs faced this time was getting a sample of the coronavirus out of China, where it originated and where controls on viral-sample shipping are strict. When I called Greninger back recently, he said he hopes that whoever is at the helm of the FDA during the next crisis will allow labs to use the virus’s genetic sequence, which is easier to obtain than a live sample, as the initial way of proving that their test works. (In response to a request for comment, an FDA spokesperson said that in the future, “if there are no available clinical specimens, FDA will consider the best approach to allow for validation with the most appropriate means available, for a limited time until clinical specimens become available.”)
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