The FDA on Monday finalized a long-awaited rule that outlines how it will regulate laboratory-developed tests (LDTs) as medical devices, even though some critics say the FDA is overstepping its authority.
The agency said the rule is needed to more closely regulate LDTs for safety and accuracy, but groups representing labs have argued that having the FDA regulate tests could slow innovation and make it harder for patients to get care.
The new rule, more than 500 pages long, allows a four-year phase-out to give the FDA and lab test developers time to become compliant. The agency will continue its existing enforcement policy for LDTs, meaning that it won’t enforce certain requirements, for products that came to market before the final rule and for those that are manufactured for an unmet clinical need.
The final rule also includes a carve-out for LDTs that are approved by New York’s Clinical Laboratory Evaluation Program.
A bill called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act aims to solidify the FDA’s authority to regulate diagnostics, but it hasn’t seen much movement in Congress since nearly passing the finish line in 2022. The legislation would establish a risk-based regulatory framework for LDTs and create a user fee program for in vitro diagnostics (IVDs).
“We are disappointed that the FDA has moved ahead with a burdensome rule based on an inflexible statute that was never designed to regulate in vitro diagnostics,” the bill’s sponsors, Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN), said in a statement. “However, we also recognize that FDA’s action today is because Congress hasn’t acted yet.”
During a call with reporters, Jeff Shuren, who oversees the FDA’s device center, said the VALID Act has a broader scope than the final rule, and it would change the regulatory framework for all IVDs.
“This rulemaking doesn’t create a new scheme for IVDs but rather phases out our general enforcement discretion approach for LDTs under our existing statutory authority,” he said. “However, we also continue to be open to working with Congress on a modern legislative framework for all tests.”
Lisa Dwyer, a partner at the law firm King & Spalding, told Endpoints News that the argument that LDTs are considered a device under the Food, Drug & Cosmetic Act is vulnerable to legal challenges.
“FDA’s final rule on LDTs does not change the nature of the decades-long battle over whether FDA has jurisdiction over laboratory developed tests — it just shifts the battlefield from FDA to the courts,” she wrote in an email. “Given the controversial nature of the rule, we expect a legal challenge.”
The American Clinical Laboratory Association said the final rule could increase healthcare costs and stifle innovation. It also doesn’t believe the FDA has the authority to do this.
“We are disappointed that FDA has continued down this path,” ACLA President Susan Van Meter said.
Bill Cassidy, ranking member of the Senate HELP Committee, came down hard on the FDA, asserting that the Biden administration is overextending its reach. He called on Congress to clarify the FDA’s authority.
“The FDA does not have the authority to unilaterally increase its regulatory jurisdiction,” he said. “This rule will undermine access to essential laboratory tests, increase healthcare costs and ultimately harm patients.”