ACLA Sues FDA to Block New LDT Oversight

In late April, FDA made the controversial ruling to amend its regulations on the oversight of laboratory-developed tests (LDT), making explicit that in vitro diagnostic (IVD) products are considered medical devices subject to rules under the Federal Food, Drug, and Cosmetics Act (FD&C Act). Along with the amendment, the agency also issued a policy to phase out its general enforcement discretion approach for LDTs over the course of four years and enforce targeted discretion polices for certain categories of IVDs manufactured by laboratories.

Now, about a month later, the American Clinical Laboratory Association (ACLA), a national trade association representing diagnostic health laboratories, has responded by filing a lawsuit against FDA in the United States District Court for the Eastern District of Texas, challenging the final rule which it says, “inappropriately seeks to regulate professional laboratory testing services as medical devices under the [FD&C Act],” according to an association statement.

Previous LDT enforcement

Historically, FDA allowed many LDTs to be used in patient care without prior review as they were seen as having fewer risks, were used on a smaller scale, and performed on common lab equipment.

“The enforcement discretion meant that the agency generally did not enforce applicable requirements to most LDTs,” MD+DI wrote in a previous article. “In 1988, LDTs were added to the Clinical Laboratory Improvement Amendments [CLIA] of 1988 standards, which is overseen by the Centers for Medicare and Medicaid Services [CMS] and state agencies.”

Since then, “LDTs and the clinical laboratories that develop and commercialize them have had to comply with CLIA and state laws relating to laboratory operations but were not required to comply with FDA’s medical device regulations due to the agency’s historical policy of enforcement discretion for LDTs,” Benjamin Zegarelli, counsel at Mintz, previously told MD+DI.

According to FDA, however, LDTs are no longer considered lower-risk, and are used more widely, for larger and more diverse populations. Additionally, LDTs are now more frequently used to guide critical medical decisions and disease diagnosis. The final rule, which will go into effect over the course of four years, will have new increased requirements, including premarket review, quality system requirements, adverse event reporting, establishment registration and device listing, labeling requirements, and investigational use requirements.

ACLA lawsuit

In ACLA’s complaint, the association — which was joined by HealthTrackRX, and endorsed by testing providers such as Labcorp and Quest Diagnostics — wrote that LDTs are not individual products, but services, meaning that they are outside of FDA jurisdiction. The trade group said that interpreting and delivering diagnostic results are based on the professional judgement of a trained lab worker.

Using the example of steps undergone when using a mass spectrometer to identify certain blood protein levels, the lawsuit wrote that, “This is a laboratory-developed testing service: a series of processes and tasks undertaken by trained laboratory professionals using instruments and other tools to derive information that may be useful to a treating physician.”

In turn, ACLA posits that FDA has no authority to regulate the professional testing services that laboratories provide — services that are already regulated by CMS and CLIA and asks the court to vacate the final rule.

“FDA’s final rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach,” said Susan Van Meter, ACLA president, in a statement. “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. 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 health care system, including millions of vulnerable patients who depend on the essential clinical testing services that only laboratory professionals can provide.”

ACLA, instead, maintains that congressional legislation “is the right — and only — approach for FDA to regulate professional testing services offered by laboratories.” Previously, ACLA supported the Verifying Accurate, Leading-edge IVCT Development (VALID) Act in Congress, but the legislation stalled.

Next steps

The case has been assigned to Judge Sean D. Jordan, who serves the Eastern District of Texas. In the short term, ACLA may seek a “preliminary injunction to prohibit the FDA from enforcing the final rule while the litigation moves forward,” according to an analysis from Goodwin Law. “A decision on a motion for preliminary injunction would be immediately appealable to the Fifth Circuit.”