Pathology Versus the FDA

When the FDA ruled on regulation of all LDTs in the US in May 2024, the pathology world was outraged. Eric Q. Konnick, of University of Washington, summed it up with this comment: “The FDA’s final rule regulating laboratory developed tests poses a huge challenge to the field of pathology. The ability of pathologists to adapt new scientific and medical knowledge to patient care could be dramatically hindered, and the financial costs to practice are likely to be greatly increased. Pathologists will be expected to comply with new regulations that are very different from CLIA requirements and have much more severe consequences for those not in compliance.”

The Association for Molecular Pathology (AMP) has escalated its concerns and taken the step of filing a lawsuit challenging the FDA’s rule (1). AMP’s President, Maria Arcila, explains, “We filed this lawsuit to ask the Court to vacate the FDA rule given the agency’s lack of authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine. AMP will continue working with key stakeholders to develop a more effective and efficient legislative framework that ensures high-quality patient care while continuing to foster rapid innovation and the promise of new diagnostic technologies.”

Many of AMP’s concerns are shared by the American Clinical Laboratory Association (ACLA), which led the way in filing a lawsuit against the same FDA ruling back in May 2023, stating, “FDA’s Final Rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach” (2).

The action led me to contemplate the likely success of such a legal challenge. Have FDA decisions been overturned in the past? 

Well, it appears they have. The courts ruled in favor of a lawsuit filed in 2019 by Catalyst, a small pharmaceutical company, claiming that the FDA’s approval of a rival’s drug was illegal under the terms of orphan designation of the drug indication (3). A complaint filed by Regenxbio successfully overturned an FDA decision that blocked its gene therapy research (4). And in June 2024, a Supreme Court ruling revoked a rule that lower courts must defer to federal agencies – like the FDA – whenever laws passed by Congress contain ambiguities (5). That decision could shift a great deal of regulatory power away from the FDA.

But the case that I found most interesting occurred at the height of the COVID-19 pandemic when some practitioners were prescribing the antiparasitic drug, ivermectin, for prevention or cure of the disease. The FDA issued a consumer update in March 2021, using social media posts, to discourage this use of ivermectin. However, the posts were later taken down after a lawsuit, filed by ivermectin’s manufacturer, challenged their legality (6).

Whilst these cases have primarily concerned the pharmaceuticals industry, the AMP and ACLA challenges to the FDA might set a powerful precedent for decisions affecting the pathology world. We await the outcome with interest.