House Appropriations Bill Seeks to Halt FDA Regulation of LDTs

With the U.S. Food and Drug Administration (FDA) on the threshold of releasing final rules for its oversight of laboratory developed tests (LDTs), the lab sector is taking a run at preserving the current regulatory model by essentially asking Congress to bring the agency to heel.

Contained in a pending FDA/agriculture appropriations bill in Congress is a provision that would suspend final regulations for the FDA’s oversight of LDTs. Instead, the agency would be directed to work with federal lawmakers to create a pathway for regulating such assays.

The bill was approved by the House Appropriations Committee on a voice vote and likely has a significant swath of supporters in both the House of Representatives and the Senate, according to Alan Mertz, president of the American Clinical Laboratory Association (ACLA).

“It should send a message to the FDA that Congress is interested in a legislative solution,” Mertz said, acknowledging that while Congress has weighed in on reimbursement issues for the sector on multiple occasions, it has not really involved itself on the regulatory end for decades.

In a statement released after the committee’s action, Mertz discussed industry support for the House Appropriation Committee’s efforts and efforts to achieve a legislative solution regarding LDTs: “The language in the bill report recognizes the need to suspend the Final FDA Guidance while Congressional authorizing committees work with laboratories, diagnostic manufacturers, providers and patients on a comprehensive framework that supports innovation and personalized patient care. This is consistent with ACLA’s position.”

The House Appropriations Committee’s language calls the FDA framework a “significant shift” concerning LDT regulation which requires public input. Most importantly, the language mirrors objections raised by ACLA that the FDA is taking the wrong path to exercising oversight of LDTs: “The FDA’s guidance circumvents the normal rulemaking process and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988. The Committee directs the FDA to suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner.”

Not everyone fully supports the bill’s attempt to stall the FDA. Connecticut Congresswoman Rosa L. DeLauro stated in her “Additional Views” on the bill that “the 2017 bill contains a number of partisan ideological provisions that completely undermine our regulatory agencies’ abilities to do their jobs, and puts the lives of children, seniors, and families at risk.” Citing the FDA as “one of our most critical lines of defense in ensuring the health and wellbeing of Americans,” DeLauro criticized the bill for restricting the FDA’s oversight of these “currently unregulated,” which she claimed “are the precipice for people receiving treatment [for] life-threatening diseases.” She exhorted that “FDA oversight of LDTs is crucial to ensuring they have been properly validated and is essential to patient safety. This viewpoint has the support of 36 patient groups who wrote to the Committee in support of FDA’s oversight of Laboratory Developed Tests.”

So… is this bill an actual legislative solution—or an end run around the FDA’s regulatory authority? Experts on the FDA and the laboratory sector suggest the latter.

“It would be an end run around the FDA if it were adopted,” said Jeff Gibbs, a director with the law firm of Hyman, Phelps & Mc- Namara in Washington, D.C. Gibbs added that the move should also be construed as a “warning shot” against the agency, although he does not believe the FDA would be deterred from issuing the final regulations.

“It would be interesting to see where Congress comes down on this debate. However, the real impact may just be a delay in regulation for some time—which, of course, most laboratories would not mind,” said Danielle Sloane, a member of the law firm Bass, Berry & Simms in Nashville, Tenn.

Potential stalling tactics aside, a significant majority of the laboratory sector has been opposed to the FDA’s regulation of LDTs. They say that tweaks to the existing CLIA regulations would address the pertinent issues.

However, the FDA has been fairly relentless in its move to try to regulate LDTs, claiming their growing complexity could place patients in danger if their accuracy and efficacy is not closely monitored. Last year, it issued a paper that listed 20 LDTs that possibly placed patients in danger—essentially a first for the agency. Meanwhile, Mertz believes that a bill in some form that preempts the proposed regulations stands a good chance of passing both chambers.

Gibbs is not so sure. He noted that there are still many steps involved in keeping the language in a final bill that would pass both houses of Congress. He also added there is resistance from test kit manufacturers, whose assays are already regulated by the FDA, as well as consumers concerned about safety issues surrounding LDTs.

“This is obviously a very unusual set of circumstances,” he said.

Nevertheless, whether Congress or the FDA has the final word, both Sloane and Gibbs expect that LDTs will eventually come under tighter regulation.

“However, the lingering uncertainty is ... unsettling,” Sloane said.

Takeaway: The laboratory sector appears to be attempting an end run around the regulation of LDTs.