Public interest and media attention around the Food and Drug Administration's proposal to regulate laboratory-developed tests (LDTs) has gone from a slow burn to steady flame in recent weeks. (“Why the FDA should regulate lab tests,”) That is a good thing. The average person should come to understand how something that may seem of remote consequence could have a chilling effect when we are at our most vulnerable—sick and in need of appropriate diagnosis and treatment.
If undisrupted patient access to innovative, safe, accurate, reliable and meaningful clinical laboratory diagnostic services is the endgame in this debate (and it should be), physicians and all of us who receive care and guidance from them are in a good place—right now. LDTs are currently regulated by the CMS under a strict framework provided by the Clinical Laboratory Improvements Act. CLIA establishes quality standards, inspections, user fees and penalties for noncompliance. In addition, all such laboratories are subject to inspection and licensure by state health authorities.
The notion put forward by the FDA that LDTs are unregulated is a gross misinterpretation at best and a red herring at worst. If regulators believe further oversight of already regulated LDTs is necessary, it should be done through the proven CLIA framework, not by creating a duplicative and unnecessary regulatory scheme at another federal agency.
Further, the FDA's decision to propose guidance rather than engage in the rulemaking process completely sidesteps the Administrative Procedure Act, bypassing key consideration of stakeholder comments as well as providing an economic analysis of the impact on the very industry it intends to regulate. Moreover, the agency proposes to regulate these testing services as “medical devices.” LDTs are know-how, not physical articles or commodities.
Dodging the rulemaking process and classifying a testing service as a medical device are certainly problematic. Interfering with the practice of medicine, as this proposed guidance will do, will jeopardize patient access to vital and innovative clinical laboratory services without offering any clear offsetting benefit.
The American Clinical Laboratory Association has long supported modernizing and strengthening CLIA as the world of diagnostic discovery leads us deeper into genomic science and nearer to clues for cures. Our goal is to promote and support diagnostic innovations that provide physicians with the information necessary to save more lives.
