FDA Warned of Overstepping Authority With Lab Test Rule Proposal

Federal efforts to bring laboratory tests to detect Covid-19, blood infections, cancers, and more under FDA authority received intense scrutiny from stakeholders that indicate significant legal hurdles for the final regulation.

The Food and Drug Administration this week faced heavy pushback on its proposed rule (RIN 0910-AI85) that would hand the agency explicit authority to regulate medical tests that come from a single laboratory, also known as lab-developed tests (LDTs). If finalized, the FDA could label LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act, requiring the products to face additional rigorous review before being marketed.

The proposal follows concerns about risks associated with new tests that have entered the market in recent years, according to the FDA. The move also trails Congress’ failure to include provisions in a 2022 year-end spending bill that would have clarified the agency’s authority over LDTs.

Clinical lab groups, academic centers, and members of Congress question the FDA’s power to regulate LDTs. The agency, which received thousands of comments on the rule by the Dec. 4 deadline, seemingly faces a rocky path forward amid litigation threats in the early rulemaking stages.

“The litigation over the LDTs rule has the potential to be the most significant litigation FDA has seen since the legal fight over the regulation of tobacco products in the ‘90s,” said Stacy Cline Amin, a partner at Morrison Foerster and the FDA’s former chief counsel.

“The lab industry views this as an existential threat and has demonstrated in the past its willingness to devote tremendous resources to challenging the agency’s attempt to assert greater regulatory oversight,” Amin said.

Questioning Power

Lawsuits confronting the FDA’s rule will be an “interesting fight,” said William Garvin, a shareholder at Buchanan Ingersoll & Rooney—given that the FDA has laid out a “litany of bad outcomes” without its regulation, while opponents argue the tests shouldn’t be under the agency’s purview.

“They’re going to throw everything at them that they can, but the primary fundamental thing is going to be: does FDA have the regulatory authority to even do this, or are LDTs not considered a medical device and they need their own statutes,” Garvin said.

The FDA’s rule would amend its regulations to make explicit that LDTs are in vitro diagnostics (IVDs) and are devices under the FDCA, including when the manufacturer is a laboratory.

The rule also puts in place a four-year phase-out period on the agency’s general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.

That power shouldn’t be handed to the FDA, the American Clinical Laboratory Association said in its comments.

The association, which represents the nation’s largest commercial reference laboratories such as LabCorp, Quest Diagnostics, and Mayo Clinic, argue the agency should be denied statutory authority and that any expansion of its role should be tailored by Congress.

The statutory authority to regulate devices delegated to the FDA in the FCDA “extends to physical products that are sold and distributed by manufacturers,” the ACLA said in its 107-page response to the agency.

“But LDTs are services offered by trained laboratory professionals, not physical products. An LDT is a protocol or process by which a laboratory uses various tools—some of which are individually regulated as devices—to derive a test result for a patient,” the association said.

The medical device framework is “dramatically ill-suited” to regulate LDTs, said Susan Van Meter, president of the ACLA.

“It is built to regulate medical devices—think of implantable spinal stimulators, defibrillators, any other manner of what you would traditionally think of as a medical device with a standard for safety and effectiveness—that framework is inflexible,” Van Meter said.

The Association for Diagnostics & Laboratory Medicine said LDTs already face regulation under the Centers for Medicare & Medicaid Services’ Clinical Laboratory Improvement Amendments of 1988, along with complementary state laws that interact with CLIA.

But those welcoming the FDA’s rule like the Center for Science in the Public Interest and the National Center for Health Research say that oversight isn’t enough.

“There’s nobody at CMS that’s saying what the sensitivity and specificity is in the test—how many false positives, how many false negatives,” said Diana Zuckerman, president of the National Center for Health Research.

That specific information will determine if a product does more harm than good, or vice versa, Zuckerman said.

“It’s not their job and that’s the kind of information that FDA needs,” she added.

Additional oversight would also ensure health-care providers and patients can rely on accurate tests, proponents say. According to the proposal, many laboratories fail to perform appropriate or adequate validation studies, which has shown data demonstrating their test doesn’t work as intended.

“The results of these mistakes will be people being told that they have diseases that they don’t have, and therefore getting treatments that they don’t need,” said Peter Lurie, president of the Center for Science in the Public Interest.

“If you don’t get the diagnosis, you won’t get the treatment,” said Lurie, who served as the FDA’s former associate commissioner for public health strategy and analysis.

‘Gauntlet’ to Congress

The FDA declining to extend the comment period on the proposal raises speculation that it’s trying to finalize certain rules in advance of the next election cycle, according to some attorneys and industry groups.

The agency’s push comes after its previous failed attempts to move forward with a successful framework to regulate LDTs. In 2014, the agency released a draft guidance that would have set the path forward, but a 2017 white paper from the FDA explained the numerous differences on the framework, which the agency declined to finalize.

Congressional efforts to give the agency power also stalled when the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act was dropped in 2022.

“This action is essentially a challenge to Congress to act. It’s sort of throwing down the gauntlet to Congress and saying, ‘if you don’t act, we’re going to act on our own,’” said Gregory Levine, a partner and chair of Ropes & Gray’s global FDA regulatory group.

The Supreme Court is hearing one case this term, Loper Bright Enterprises v. Raimondo, also raises doubt about the agency’s rulemaking timeline, as justices weigh whether to continue giving agencies “Chevron deference” for interpretations of ambiguous terms in their statutes.

“We’re facing a Supreme Court that I think would be most hostile to administrative agencies and their expansion of powers—that I’ve seen in my lifetime,” Garvin said. “That makes it a much more interesting case about whether or not FDA is going to be able to regulate this space under just rulemaking.”