The FDA, which has just introduced a gadget that handles sensory organs still in action on the corpse (an artificial nose, or "electronic nose"), has been criticized publicly. Therefore, it is confronted by two contradictory attitudes. One is a certain amount of faith and trust at medical exhibitions and hospital open days in the future; on the other hand. The FDA action is called "arbitrary, capricious and abusive" in a lawsuit filed Monday in the Southern District of Texas. It was the 27th court challenge to FDA rules involving LDTs.

AMP and Laposata's lawsuit is aimed at overturning the rule, which gives the FDA extensive control over LDTs-typically used by in-house hospital and healthcare labs. AMP President Maria Arcila expressed concern in the trade group's statement for rule's "wide-sweeping and long-lasting consequences." She notes that the association is taking legal action to prevent disruptions in laboratory medicine.

The lawsuit is the second one of its kind recently filed, the other being a suit from the American Clinical Laboratory Association in May. The two suits both argue that FDA lacks legal authority to regulate LDTs, traditionally under the authority of Centers for Medicare & Medicaid Services through Clinical Laboratory Improvement Amendments (CLIA).

The complaint emphasizes how much of an economic burden this new rule could place on laboratories. For example, FDA estimates cited by AMP see initial compliance costs totaling up $114 billion with annual costs of $14.31 billion additional. AMP argued that these projections underestimated the true costs, especially for smaller labs serving a rural or disadvantaged community area, which might have difficulty achieving regulatory compliance.

The group also warned that the rule could stifle innovation and harm patients if smaller labs were forced to close or consolidate, limiting access to diagnostic testing in underserved areas. The lawsuit claims that "patients would pay the ultimate price," as certain diseases could go undiagnosed due to fewer available testing options.

However, FDA Commissioner Robert Califf supported the move, saying that as the use of LDTs increases it's important for people to have confidence that if they are using these tests at all their results will be accurate and reliable.

Historically, LDTs have been regulated jointly by the FDA and CMS. By the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, Congress gave to FDA the authority to regulate medical devices, while CMS has responsibility for laboratory practice under CLIA. AMP’s complaint calls upon Congress’s purported intent not to have the 1976 Medical Device Amendments cover LDTs for one thing Congress viewed them as distinct from commercially distributed medical devices. FDA Regulatory Oversight: A Course of Action

Despite legal challenges, the FDA is moving forward with implementing the new rule, and compliance is set to start in May 2025. The agency has been criticized by congressmen and trade groups for significantly expanding its regulatory scope, particularly given the recent Supreme Court rulings affecting regulatory deference.

No comment yet from the FDA on the lawsuit. Legal Representation and Case Information

AMP and Laposata are represented by Fred D. Raschke of Mills Shirley LLP and a team from Hyman Phelps & McNamara PC. The case is Laposata et al. v. United States Food and Drug Administration et al., case number 3:24-cv-00241, in the Southern District of Texas, Galveston Division.