Stacy Cline Amin spoke to POLITICO Pro about the Department of Health and Human Services (HHS) withdrawing a Trump-era legal determination that the Food and Drug Administration (FDA) lacks the authority to require premarket reviews of laboratory developed tests for COVID-19 and other conditions.
According to Stacy, the FDA is prepared to defend its legal position in the event of litigation.
“HHS tried to make law through a web posting, you can’t do that,” Stacy said. “The legal memo that was leaked was inaccurate, incoherent, and inconsistent. I think FDA believes its legal footing is strong.”
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