FDA’s Proposed LDT Rule Trumped by VALID Act, Hearing Speakers Say

Those who work with laboratory developed tests (LDT) would have much preferred their rapidly developing field be regulated by the Verifying Accurate, Leading-edge IVCT Development (VALID) Act — but since Congress has repeatedly failed to pass the bipartisan act, the field is now reeling at the “overreach” of the FDA’s new proposed rule on regulating LDTs.

That was the upshot of Thursday’s three-hour House Energy and Commerce Committee subcommittee hearing that was slated to focus on the impact of the FDA’s proposed rule, announced in September.

Several legislators at the hearing said they also thought the VALID Act was a better way to regulate LDTs, which FDA Commissioner Robert Califf said in September are now being offered by labs “without assurance that they work.” And all but one of the five experts testifying at the hearing agreed that the field of LDTs would be irreparably harmed by the FDA’s proposed rule.

Read the proposed rule here.

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