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The Department of Health and Human Services is paying a private firm to review the accuracy of some Covid-19 tests — the latest example of the department’s political leadership attempting to bypass scientists at the Food and Drug Administration.
The idea behind the last-minute contract, announced days before President Donald Trump leaves office, is that HHS would use the review to issue emergency use authorizations for the tests without input from FDA.
It comes as the health department has scrambled to force through several new FDA regulations — sometimes without the agency’s knowledge, and sometimes over its objections.
The noncompetitive, sole source contract HHS recently signed with NDA Partners — a Rochelle, Va., consulting firm that employs former top FDA regulators — is only worth a maximum of $1.5 million. Public health experts said the decision is largely symbolic, since the incoming Biden administration could return responsibility for reviews to FDA. But it comes after a bruising pandemic year for the agency and its scientists, who Trump without evidence repeatedly accused of slowing down progress of tests, drugs and vaccines for political reasons.
“It’s concerning because it gives at least the strong appearance that these decisions about scientific questions are being taken away from the FDA and lodged elsewhere,” said Rachel Sachs, an associate professor of law at Washington University in St. Louis. “The emerging picture for HHS Secretary Azar seems to be to bind the hands of FDA as much as he can going forward, before he leaves office.” ...
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