House Democrats say the department’s decision is another example of politics guiding the Trump administration’s coronavirus response.
Two months before Health and Human Services Secretary Alex Azar overruled FDA officials to revoke the agency's oversight of lab-developed tests this August, the health department's top lawyer began building a legal case that would lead to its controversial decision to remove that authority, according to a memo obtained by POLITICO.
Lab-developed tests are created and used within a single laboratory for a wide range of diseases. There's long been questions about whether FDA had the authority to regulate these tests as medical devices, which include certain offerings from lab giants like Quest and LabCorp. But the timing of HHS' decision raised eyebrows among public health officials who worry that looser standards will allow a surge of unreliable Covid-19 tests, as was the case early in the outbreak.
Story continues“We have been asked by departmental leadership to review the legal bases — both substantive and procedural — for FDA’s regulation of laboratory developed tests,” Charow wrote in that memo.
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