HHS Reverses Course on Trump-Era Policy on Lab-Developed Tests

Statement of CSPI President Dr. Peter G. Lurie

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The top job for the Food and Drug Administration, and for Dr. Robert Califf if he is confirmed as its new Commissioner, is restoring the agency’s reputation for scientific integrity and independence.

When in October 2020 the Trump administration’s Department of Health and Human Services effectively blocked the FDA from regulating laboratory-developed tests for COVID-19 or other diagnoses, over FDA’s objection, the move was rightly seen as a threat to FDA’s integrity and independence. And so it is very good news that the Biden administration has reversed HHS’s policy as part of a broader effort to ensure the reliability of at-home test kits for COVID-19. Requiring Emergency Use Authorizations for many COVID-19 diagnostics is a judicious step forward. What the country needs is not more tests per se; it needs more accurate ones as well.

Americans deserve confidence that their drugs, diagnostics, and medical devices are safe and approved for use by regulators at the FDA. It was a mistake for the Trump administration to exempt lab-developed tests from the agency’s regulatory portfolio, granting a longstanding industry wish, and its reversal is a sign that President Biden will continue to try to undo his predecessor’s efforts to sabotage the agency.

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