The Food and Drug Administration did not appeal a recent U.S. District Court decision that set aside the agency’s final rule aimed at increasing its authority over laboratory developed tests, according to two lab industry groups.
The 60-day window for the FDA to appeal the ruling by the U.S. District Court for the Eastern District of Texas expired over the weekend. The Association for Molecular Pathology supported the FDA’s move not to appeal.
“This decision should finally conclude the FDA’s unwarranted and overreaching attempts to assert regulatory authority over LDTs,” AMP President Jane Gibson said in an emailed statement.
AMP, which represents pathologists, doctoral scientists and other laboratory professionals, was one of the groups that sued the FDA to block the rule, which would have greatly expanded the agency’s regulatory authority over LDTs. Lab professionals feared the changes would have jeopardized patient care and test innovation and could have forced smaller labs to close.
“The court’s favorable ruling was a significant victory for patients and healthcare providers across the country,” Gibson said. “AMP remains firmly committed to safeguarding the interests of our members and the patients we serve.”
LDTs are regulated under the Centers for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments statutory framework. AMP members will continue to collaborate with policymakers to clarify current CLIA regulations and help shape an appropriate legislative framework to support the court decision, Gibson added.
The Department of Health and Human Services’ decision not to appeal the ruling confirms that LDTs are not medical devices subject to the agency’s regulatory oversight, the American Clinical Laboratory Association, which also sued the FDA, said in a LinkedIn post.
HHS Press Secretary Emily Hilliard declined to comment on the decision.
“We look forward to continued collaboration with policymakers to support patients, innovation, and America’s clinical laboratories,” the ACLA wrote.
TD Cowen analysts said the decision not to appeal was not a surprise, noting the first Trump administration also moved to stop the FDA from regulating LDTs, only to have the Biden administration reverse that plan.
“The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” the analysts wrote in a note Monday. They added that the measure is unlikely to come up again under the Trump administration, though a Democrat-led FDA may try to revive it.
Legislation called the Verifying Accurate, Leading-edge IVCT Development Act, which would reform the regulatory framework for in vitro diagnostics, has not gained momentum in Congress in recent years despite multiple attempts to advance the bill.
