Bethany Hills spoke to Law360 for an article examining the top issues healthcare attorneys are watching as the COVID-19 pandemic faces a potentially harrowing winter.
According to Bethany, the U.S. Food and Drug Administration (FDA) is prioritizing emergency use authorizations (EUA) for certain products – such as rapid coronavirus tests, vaccines, and therapeutics – and “giving less attention to others,” including mask decontamination units. FDA staffers also aren’t even reviewing preliminary packages of information about EUA requests until they’re virtually complete, she said.
“FDA is imposing necessary procedural limitations,” Bethany said. “They are totally overwhelmed with a huge volume of EUA-related submissions and [are] under-resourced, so in my view it is necessary, as they are trying to get control of the situation.”
Bethany also told Law360 that she foresees serious scrutiny of the vast and varied marketplace of COVID-19 tests after that marketplace emerged quickly with overhyped claims about speed and accuracy.
“This is the area that I worry about the most for the future,” Bethany said. “We expect that in a few years we will start seeing significant enforcement actions looking into how the COVID tests were advertised, how results were delivered, how much was charged and paid, and how accurate the tests actually were.”
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