Understanding the Food and Drug Administration's Jurisdiction Over Laboratory-Developed Tests and Divisions Between Food, Drug, and Cosmetic Act-Regulated and Clinical Laboratory Improvement Amendments of 1988-Regulated Activities

The scope of the Food and Drug Administration’s (FDA’s) jurisdiction over laboratory-developed tests (LDTs), and whether FDA has such jurisdiction at all, has been a heavily debated issue over the past several years. With FDA’s release of draft guidance in October 2014 detailing its proposed framework for regulating many LDTs, the issue has become even more contentious. On a basic level, there are 2 sides to the debate: (1) those who believe FDA’s efforts to expand its authority to regulate LDTs are unlawful and detrimental to the practice of medicine and diagnostic innovation; and (2) those who believe FDA should step in to regulate at least a subset of LDTs due to the potential harm they may cause in the absence of regulation. The former tend to include clinical laboratories and hospitals, whereas the latter tend to include FDA, certain patient groups, and in vitro diagnostics (IVD) manufacturers.

If FDA moves forward with its guidance, or Congress takes action to reform LDT and IVD regulation, a fundamental question that needs to be answered is how to divide activities regulated by the Food, Drug, and Cosmetic Act (FDCA) from those regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Without a clear framework, any new regulatory system could be a major challenge to navigate, and could lead to duplicative regulation. Unfortunately, in the LDT debate, we rarely get to into these important details because both sides are entrenched in arguing generalities: FDA can do anything it wants or nothing at all with respect to LDTs. Therefore, in this article, we consider FDA’s authority to regulate LDTs and the policy implications of regulation, and discuss an idea for a fact-driven framework to distinguish FDCA and CLIA activities.