A national trade group representing laboratories filed a lawsuit against the FDA on May 29, arguing the agency's recent final rule to treat laboratory-developed tests as medical devices exceeds its statutory authority.
The lawsuit was filed by the American Clinical Laboratory Association and one of its member companies, HealthTrackRx, in the U.S. District Court for the Eastern District of Texas. The suit argues that Congress has not granted the FDA the authority to regulate professional testing laboratory services.
Under the new rules, the FDA will phase in oversight of laboratory-developed tests, or LDTs, over a four-year period. LDTs are those designed, manufactured and used within a single clinical laboratory, often in hospital and academic medical center labs. FDA officials have said the rule "aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and healthcare providers can trust."
Industry analysts anticipated the rule would face legal challenges from organizations such as the ACLA, which claims the move could limit patient access and stifle innovation.
"The medical device framework is inappropriate and ill-suited for regulating laboratory-developed tests, which are services provided by trained professionals rather than manufactured products," Susan Van Meter, president of the ACLA, said in a statement. "These professional services incorporate the latest scientific advances to offer innovative testing solutions to physicians and the patients they serve. The Rule will disrupt this paradigm, creating negative consequences for the entire healthcare system, including millions of vulnerable patients who depend on the essential clinical testing services that only laboratory professionals can provide."
Before releasing the final rule, federal regulators said they made adjustments in consideration of public comments they received on the draft version of the rule. Per the final rule, the FDA will give enforcement discretion to tests currently on the market, essentially grandfathering them into approval. Enforcement discretion also applies to tests manufactured and performed within a healthcare system "to meet an unmet need of patients receiving care within the same healthcare system when an FDA-authorized test is not available."
The American Hospital Association has also opposed the rule, saying the decision to impose device regulations on LDTs could increase hospital costs, though the organization did say it "appreciated" the enforcement discretion laid out in the final rule.
The FDA told Becker's in a statement May 30 that it does not comment on "possible, pending or ongoing litigation."
The new rule can be found in full here.