The introduction of a new Final Rule by the Food and Drug Administration (FDA) regarding Laboratory Developed Tests (LDTs) has sparked a wave of legal challenges.
This regulation forces laboratories to adhere to the same preapproval and post-marketing standards that apply to traditional medical devices.
FDA’s Authority and Regulatory Shift
In essence, the FDA’s Final Rule underscores its long-held authority to impose legal standards on LDTs.
Historically, the FDA chose not to enforce these regulations rooted in the Medical Device Amendments of 1976, primarily because LDTs were originally crafted by specialized professionals for specific patient needs in small quantities.
However, as LDTs have become more widely distributed to diverse populations, the FDA is now asserting its right to enhance regulatory oversight.
As a result of this regulatory shift, two lawsuits have been filed against the FDA: American Clinical Laboratory Association et al v. U.S. Food and Drug Administration et al. (ACLA) and Association for Molecular Pathology et al. v. U.S. Food and Drug Administration et al. (AMP).
The plaintiffs argue that the FDA’s actions could stifle medical innovation, diminish healthy competition, impose hefty regulatory expenses, and potentially endanger the health of millions.
Both cases have been consolidated in the United States District Court for the Eastern District of Texas for joint consideration.
Legal Arguments and Summary Judgment Motions
The consolidated lawsuit claims that the FDA has overstepped its legal authority.
Citing the Congressional Record, the plaintiffs argue that Congress has specially authorized the FDA to regulate medical devices, distinguishing between mass-produced items for third-party usage and customized LDTs engineered by skilled healthcare professionals in accredited settings.
Furthermore, they point out that Congress has not allocated adequate resources for the FDA to oversee the myriad of testing services, given that LDTs have already been regulated under the Clinical Laboratory Improvement Amendments (CLIA).
In September 2024, the plaintiffs submitted a motion for summary judgment, and the FDA responded with a cross-motion to oppose their requests.
Most recently, on December 23, 2024, the plaintiffs filed their reply, bringing the briefing process to a close.
In September 2024, ACLA filed a motion requesting the court to nullify the Final Rule and bar the FDA from enforcing it.
The plaintiffs contend that the FDA must provide a compelling justification for classifying laboratory testing services as medical devices, arguing that Congress did not grant such regulatory power.
They stress that the FDA’s justification for the new regulations is insufficient.
Defendants’ Position and Future Implications
AMP’s motion mirrors these requests, asking the court to vacate the Final Rule and halt enforcement.
They assert that the Federal Food, Drug, and Cosmetic Act (FDCA) does not authorize the FDA to regulate LDTs as medical devices, describing the Final Rule as arbitrary and unjustified.
Together, the plaintiffs argue that Congress only entrusted the FDA with authority over physical medical devices, establishing a framework for monitoring misbranding and adulterated products.
They emphasize that LDTs, being multi-step procedures executed in lab settings by qualified professionals, do not fit this definition.
Additionally, despite enhancements to CLIA in 1988, the FDA has resisted expanding its oversight of laboratories.
They argue that existing regulations sufficiently assure quality and performance while enabling laboratories to meet patient needs.
The plaintiffs point out a critical distinction: the FDA’s quality measures focus on ensuring commercial devices remain unchanged and largely revolve around monitoring adverse events.
They highlight the FDA’s historical reluctance to claim authority over LDTs and the consistent congressional rejection of efforts to expand the FDA’s reach.
This constitutes a pivotal legal question for the court.
Moreover, AMP’s motion emphasizes that the FDCA prohibits the FDA from restricting healthcare providers’ discretion in prescribing legal medical devices.
AMP also asserts that the Final Rule is arbitrary and capricious, alleging that the FDA misinterpreted anecdotal evidence to justify its implementation.
The FDA cites rising concerns over LDTs, yet among the many LDTs in use, only a small number have raised issues since 2008.
AMP argues that enforcing FDA standards on LDTs lacks a solid rationale, leading to skyrocketing compliance costs, reduced competition, potential lab closures, stifled innovation, and risks to patient health.
Both sets of plaintiffs reference the significant 2024 case Loper Bright Enterprises v. Raimondo to bolster their case against the FDA’s discretionary authority.
They urge the court to assert its independent judgment regarding whether the FDCA indeed permits the FDA to regulate LDTs rather than simply accepting agency interpretations of vague laws.
In their closing replies, the defendants have called upon the court to avoid an outright annulment of the Final Rule.
If the ruling does not favor them, they seek further clarification on the appropriate next steps.
They argue that the Final Rule does not fall under the major questions doctrine or the rule of lenity, maintaining that the FDA possesses clear statutory authority over LDTs and that the rule itself is reasonable and justified.
Defendants stress that their implementation of the Final Rule stems from a clear mandate from Congress, asserting that they have not arbitrarily defined their jurisdiction over LDTs but are merely executing established legislative directives.
They vigorously challenge the plaintiffs’ interpretations while defending the statutory language, underscoring that there is no inherent conflict with CLIA, given their duty to ensure clinically valid outcomes for patient safety.
With all necessary briefs now submitted, the court’s decision remains uncertain.
At this stage, no new updates have been released.
Ongoing developments regarding the Final Rule will continue to be monitored closely.
Source: Natlawreview