Devices

Lab Association Sues FDA Over LDT Rule

David McFarland

— 2 min read
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The American Clinical Laboratory Association (ACLA), HealthTrackRX Indiana, and HealthTrackRX, Inc., are suing FDA in a Texas federal court to challenge the agency’s 5/6 final rule announcing its intent to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FFDCA). “Because the final rule exceeds FDA’s lawful authority and is arbitrary and capricious and contrary to law, the rule should be set aside and vacated, and defendants should be enjoined from enforcing or implementing the rule,” the suit says.

ACLA and the other plaintiffs say that for decades LDTs have been regulated under the Clinical Laboratory Improvement Amendments Act of 1988 “that imposes numerous laboratory-specific standards to ensure the validity and reliability of laboratory diagnostic testing services, including the training and qualifications of the skilled professionals who perform, supervise, and interpret the tests.”

Congress has never given FDA authority to regulate professional laboratory-developed testing services, the suit says, and the agency’s final rule “threatens to upend the nation’s entire laboratory profession by seeking to regulate all LDTs as if they are medical devices under the FFDCA. In asserting authority to transform the regulatory framework that has been applied for decades, FDA cannot point to any new statutory authority granted by Congress. Nor can FDA contend that Congress has ever provided it with the resources that would be necessary to retain the personnel and build the expertise necessary to exercise sweeping authority over the thousands of testing services provided by the nation’s laboratories. To the contrary, Congress has recently entertained legislative proposals that would have granted FDA new authority to regulate LDTs, and it has declined to provide FDA that power.”

The suit says FDA’s position is that when Congress expanded its authority to regulate medical devices in 1976, it also quietly intended to outlaw and subject to substantial civil and criminal penalties any professional LDTs that were not first approved or cleared by FDA. It says the agency says that the only reason LDTs have not been civilly and criminally punished is that FDA has exercised enforcement discretion.

“If it is not vacated,” the suit warns, “FDA’s unprecedented final rule will have devastating and far-reaching consequences not only for the nation’s clinical laboratories, but also for the nation’s entire healthcare system, including the millions of vulnerable patients who depend on the essential clinical testing services the laboratories provide.”

ACLA and the plaintiffs make these points:

  • LDTs are services carried out by highly skilled and trained laboratory professionals;
  • FDA’s statutory authority to regulate medical devices does not extend to professional services;
  • Congress created a separate and distinct framework for regulating laboratory testing services;
  • FDA has never broadly regulated laboratory testing services as medical devices;
  • FDA now seeks for the first time to classify virtually all laboratory testing services as medical devices; and
  • HealthTrackRX and other ACLA members face irreparable harm from FDA’s final rule.

The suit says FDA’s action violates the Administrative Procedure Act in two ways—(1) it is contrary to law, in excess of statutory jurisdiction and authority, and contrary to constitutional right and power; and (2) it is arbitrary and capricious and an abuse of discretion.

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