Original from: 360dx

The Association for Molecular Pathology and Michael Laposata, a pathologist at the University of Texas Medical Branch-Galveston, have filed a lawsuit against the US Food and Drug Administration challenging the agency's May 6 final rule on laboratory-developed tests (LDTs).

In the suit, filed in the US District Court for the Southern District of Texas on Monday, AMP argues that the rule, which gives the FDA oversight of LDTs, exceeds the agency's legal authority. It has requested that the court vacate and set aside the rule and enjoin the FDA from enforcing it.

The suit is the second to challenge the FDA rule, following a suit filed by the American Clinical Laboratory Association and its member company HealthTrackRx in May.

The FDA has maintained for more than three decades that it has the authority to regulate LDTs under the Federal Food, Drug, and Cosmetic Act (FDCA). It has historically declined to exercise this authority, instead adopting what it has called a policy of enforcement discretion.

More recently, however, the agency argued that its policy of enforcement discretion was no longer appropriate given the increasing complexity of LDTs and their ubiquity throughout the healthcare system, including for the diagnoses and management of life-threatening conditions. It has also noted many vendors now offer their tests as LDTs as a way of avoiding FDA regulation, even though these tests were marketed to large and diverse customer bases much like traditional IVDs.

Following the collapse in 2022 of Congress' effort to pass legislation giving the agency explicit oversight of LDTs, the agency began its own efforts to regulate these tests through the rulemaking process. This effort was opposed by much of the clinical lab industry, which has raised concerns that FDA oversight will hamper lab innovation and flexibility, limiting test development and, ultimately, harming patient care. When the FDA published its final rule on LDTs in May, legal challenges to the rule were widely expected.

AMP has strongly opposed the FDA's efforts to regulate LDTs, maintaining that oversight of these tests would best be handled through modernization of the existing Clinical Laboratory Improvement Amendments (CLIA) regulations.

In a statement announcing the lawsuit, AMP President Maria Arcila said that "AMP remains very concerned about the wide-sweeping and long-lasting consequences the FDA rule will have for our members and patients across the country," and reiterated its belief that the agency lacks the legal authority to regulate LDTs.

Source: AMP Sues FDA Over Laboratory-Developed Test Final Rule