Lab Sector Goes to Big Legal Guns in Grapple With FDA Over Test Regulation

The American Clinical Laboratory Association (ACLA) has officially loaded up its legal howitzers in a likely path toward litigation over the U.S. Food and Drug Administration’s (FDA’s) intent to regulate laboratory-developed tests (LDTs).

ACLA recently retained the services of renowned attorneys Laurence H. Tribe and Paul D. Clement, both of whom have voluminous experience litigating and appealing cases in the federal courts.

Tribe, 71, a professor of constitutional law at Harvard University, is perhaps the foremost legal scholar in the United States. He has argued nearly three dozen cases in front of the U.S. Supreme Court since the early 1980s, winning about 60 percent of them.

Clement, 48, is a partner in the Washington, D.C., law firm of Bancroft PLLC, which specializes in Supreme Court and federal appellate litigation. He was a solicitor general in the George W. Bush administration, arguing cases on its behalf in front of the Supreme Court. In private practice, Clement argued in front of the high court in 2012 against the constitutionality of the Affordable Care Act.

Although ACLA trumpeted its hiring of Tribe and Clement in a press release issued last week, ACLA President Alan Mertz would not say specifically whether the organization plans to sue the FDA, perhaps with the intent of establishing in federal court that agency’s authority—or lack thereof—to regulate the laboratory sector.

Instead, Mertz has stuck to the argument that the FDA’s regulation of LDTs would duplicate the regulatory oversight already provided by the Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists, and regulators in states such as New York and Florida.

The FDA announced last July that it intended to regulate LDTs much in the way it currently regulates medical devices, with a vetting process based on the risk of each test to patients. It issued a 43-page framework last month, which is currently open for public comment until February.

“We’re not against oversight—just the way they’re doing it,” said Mertz, who added that the ACLA wants a withdrawal of the FDA’s draft regulations of LDTs.

The FDA has countered that the current system under CLIA is unsatisfactory and has created a market full of complex assays, some of which have been vetted by the agency and others that have not.

“For a long time, we have supported making some modifications to CLIA, and we can add on to [its] process of authority,” Mertz said. “You can make some additions to that that would be far less destructive to innovation, and not just re-create the wheel.”

The hiring of Tribe and Clement appears to be timed with increasing pressure on the FDA from outside organizations. On the same day as ACLA’s announcement, the American Association for Clinical Chemistry, the American Medical Association, the American Hospital Association, and a variety of other health care trade organizations called on the FDA to withdraw its proposed regulatory framework.

FDA spokesperson Jenny Haliski declined to comment specifically on the possibility of litigation from the lab sector. “The agency looks forward to receiving feedback from all stakeholders on the draft guidance and intends to hold a public meeting early next year to get further input from all interested parties,” she said.

Takeaway: With the hiring of perhaps the two best-known appellate lawyers in the United States, ACLA appears poised to sue the Food and Drug Administration over its intent to regulate laboratory-developed tests.   

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