FDA’s Summer Plans May Include LDT Rulemaking

The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn.  In the most recent Unified Agenda, which is a list of planned regulatory actions published semi-annually by the Office of Management and Budget (OMB), FDA announced its intent to issue a proposed rule “to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.”  The Notice of Proposed Rulemaking (NPRM) for LDTs is scheduled to be published in the Federal Register in August.

Whether we will actually see a proposed rule in August is more than a little uncertain, however.  Take for example FDA’s Unified Agenda announcement for ISO 13485 harmonization, which first occurred in the Spring of 2018 and was re-issued until a proposed rule was published in early 2022 (see our post here).  Thus, simply because the Unified Agenda targets August, it doesn’t necessarily mean it will be August or even this year.  The difference between a proposed LDT rule and ISO 13485 is that the Unified Agenda categorizes LDTs as “Significant” priority as compared to ISO 13485, which was “Non-Significant.”

Timing aside, FDA’s plans should not come as a surprise.  In the wake of Congress’ failure to enact the VALID Act last year, Commissioner Califf and CDRH officials have made public statements affirming the Agency’s intent to take matters into its own hands and initiate LDT rulemaking.  The announcement in the Unified Agenda of a planned NPRM is the most concrete evidence that FDA is moving forward with this plan.

Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs.  These include FDA’s efforts to use guidance as the vehicle (see posts here, here, and here) and the multiple attempts to pass the VALID Act (see posts here and here).  So far, all of these efforts have been fruitless.  Given the make-up of the House and the aversion to expansion of FDA authority, it seems extremely unlikely that the newest version of the VALID Act, which was introduced in March 2023, will advance in the next two years.  And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.  See, e.g., ACLA White Paper on LDTs here.  Rulemaking avoids the twin problems of dependency on action by Congress and the legal weakness of imposing substantive legal requirements through guidance.

Of course, the rulemaking process has its own uncertainties.  Once the NPRM is published, the public will have the opportunity to submit comments; given the wide range of stakeholders that would foreseeably be affected by FDA oversight of LDTs, the docket will no doubt be voluminous.  It will inevitably take FDA a substantial period of time to review these comments and incorporate responses in a final regulation.  Before a final rule can be issued, it will be scrutinized both by the Department of Health and Human Services and OMB.  FDA will also need to conduct an economic impact analysis pursuant to Executive Orders 12866 and 13563, which direct FDA to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including economic benefits).  All of this will take time.  And, of course, there is the political calendar.  If there is a change in administration, this process will almost surely be halted immediately, unless the current administration abandons the effort on its own, as it did in 2016 (see post here).

Even if a final rule is issued, that will not be the end of the story.  The NPRM merely says that the regulation would make explicit that LDTs are devices, but what that means and how the existing device framework would apply to LDTs remains a mystery.  Would there be a new regulatory framework, as is proposed in VALID and outlined in FDA’s 2017 discussion paper (see our prior post here), or something different?

Moreover, while rulemaking may shield FDA from some procedural challenges, the imposition of substantive new requirements on clinical laboratories would be very likely to prompt lawsuits on other grounds.  Opponents of LDT regulation received a boost with last year’s Supreme Court decision overturning an agency action based on the “major questions” doctrine, West Virginia v. EPA.  Depending on what happens in the next few weeks in Loper Bright Enterprises v. Raimondo, FDA may also lose the shield of Chevron deference in any litigation.

In sum, the notice of a projected NPRM is not the end of the LDT story, or the beginning of the end, or even the beginning of the beginning of the end.  We still expect to be blogging about FDA’s efforts to regulate LDTs for years to come.