ARTICLE | Politics, Policy & Law

LDT policy: back to murky

FDA’s LDT policy has gone full circle from murky to terrible and back; next year may be better

November 20, 2021 1:00 AM UTC

In two separate, overlapping policies, the Biden administration has erased a contentious Trump administration policy on the regulation of laboratory developed tests and imposed new premarket review requirements for COVID-19 tests.

HHS Secretary Xavier Becerra’s reversal of his predecessor’s decision to bar FDA regulation of LDTs was expected. Serving and former FDA officials, public health experts and Democratic members of Congress criticized former HHS Secretary Alex Azar’s LDT policy. They portrayed it as an attempt to use a flawed legal analysis to justify an ideologically motivated deregulatory policy and warned that it created unnecessary public health risks. ...