Trump administration’s defense of LDT rule catches legal expert by surprise

The Trump Administration’s move to defend the US Food and Drug Administration’s (FDA) rule regulating laboratory-developed tests (LDTs) has caught some experts off guard, including Philip Desjardins, a partner at Arnold & Porter, who told Focus he expected the government to walk back the rule.

Last year, FDA finalized a rule that would increase its regulatory oversight of LDTs and phase out its longstanding enforcement discretion policy. The final rule followed attempts in Congress to pass legislation, such as the Verifying Accurate, Leading-edge IVCT Development (VALID) Act to bring about LDT reform and give FDA explicit authority over such tests, as well as a failed effort by FDA to do so via guidance in 2014. (RELATED: FDA issues long-awaited LDT final rule, Regulatory Focus, 24 April 2024)

In response, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) sued FDA, arguing that the agency has no authority to regulate LDTs. On 19 February, the lobby groups representing clinical laboratories and the Department of Justice (DOJ) representing the Department of Health and Human Services (HHS) presented their case during oral arguments before the US District Court for the Eastern District of Texas in Plano.

Desjardins, who listened to the hearings, was surprised that the Department of Justice (DOJ) counsel defended the rule instead. Desjardins explained that DOJ could have acted in one of three ways. One path would be to defend the rule, as it had during the Biden administration, and another would have been to walk away from the case by changing the government’s argument, declining to advocate their position, or advocating in a way that would have led to the lawsuit being dismissed. A third option would have been to request a continuance to postpone the issue.

“What ended up happening was a full-throated defense of the rulemaking,” said Desjardins. “It's the same oral argument I would have anticipated hearing in October of last year, prior to the elections.”

“To me, that was somewhat surprising,” he added. “Not that it was outside the realm of possibility, but what it means is the new administration, at least in the context of this litigation, has not changed their external policy on this regulation.”

Desjardins said that it is possible that the administration’s policy on the LDT rule hasn’t changed yet because they haven’t had time to formulate a new policy. He noted that even if LDTs were a priority for the new administration, they have been very active in other areas and may not have had enough time to prepare a new oral argument and change their course of action and strategy.

Trump administration’s defense of LDT rule catches legal expert by surprise

Related topics

Recommended content

Welcome to the new RAPS Digital Experience