Labs Want Congress to Intervene on LDT Regulation

With the U.S. Food and Drug Administration on the threshold of releasing final rules for its oversight of 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 the pending FDA/agriculture appropriations bill in Congress is a provision that would suspend final regulations for the FDA’s oversight of laboratory-developed tests. 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.

Even in Washington’s current polarized political climate, appropriations bills are usually passed by Congress and signed into law, because much of the federal government would grind to a halt without the funding they provide. It is also fairly commonplace for lawmakers to insert into appropriations bills only tangentially related legislation that would draw much closer scrutiny if introduced as standalone pieces of legislation.

Is it 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 & McNamara 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.