ANAHEIM, CALIFORNIA – Last year, the American Association for Clinical Chemistry (AACC) was a leading opponent of congressional efforts to pass legislation giving the US Food and Drug Administration explicit authority to regulate laboratory-developed tests (LDTs).
A year later, that legislation, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, appears stalled in Congress. The battle over LDTs continues, however, with the FDA having announced plans to regulate these tests through the rulemaking process. At last week's annual meeting here, AACC, which has changed its name to the Association for Diagnostics & Laboratory Medicine (ADLM), made it clear that it is poised to oppose this effort, as well.
The FDA has maintained for more than 30 years that LDTs are medical devices that fall under its authority according to the Food, Drug, and Cosmetic Act (FDCA). This supposed authority has been disputed by many in the lab industry, however, and the agency has by and large refrained from regulating LDTs, adopting what it has called a policy of enforcement discretion.
In recent years, lawmakers worked to craft and pass legislation, most notably the VALID Act, that would give the FDA authority over LDTs. However, following VALID's failure last year to move through Congress, the agency announced that it would resume efforts to establish oversight of these tests.
The FDA has said it plans to release its proposal on LDTs in August, and last week the Office of Management and Budget said that it has received the agency's proposed rule. Following the release of the rule, there will be a 60-day public comment period during which stakeholders can make comments that the FDA must address when it produces its final rule.
The scope of the FDA's rule on LDT regulation remains unclear, but ADLM members involved in the organization's fight against VALID identified the upcoming public comment period as key to their efforts opposing this latest initiative.
During a session on political advocacy at the recent AACC meeting, Patricia Jones, chair of the organization's Policy and External Affairs Core Committee (PEACC), said the committee is planning grassroots organizing to encourage as many people as possible to leave public comments on the FDA's rule on LDTs once it is posted.
Christina Lockwood, associate director of the genetics and solid tumor diagnostics laboratory at the University of Washington, likewise noted the importance of the public comment period. She added that if the FDA does move forward with rulemaking on LDT regulation, "then, ultimately, the legal case that is going to follow that will be very important."
Whether the FDA actually has the authority to regulate LDTs via rulemaking or otherwise remains an open question. Speaking to 360Dx earlier this year, Jeff Gibbs, a director at the law firm Hyman, Phelps & McNamara, who formerly served as the FDA's associate general counsel for enforcement, said that "there is no question FDA is going to run into a court challenge when they" attempt to regulate LDTs.
A 2020 internal memo from Robert Charrow, then general counsel at the US Department of Health and Human Services, lays out several main challenges such an effort might face. The memo argued that while, assuming it proceeded via rulemaking, the FDA would likely prevail in the argument over whether LDTs are medical devices, in order to regulate LDTs under the FDCA, the agency would still need to demonstrate that these tests meet the definition of interstate commerce, that they are in commercial distribution, and that the laboratories performing them are legal "persons."
The memo noted that while the FDA could likely demonstrate that LDTs fell under interstate commerce, it was less clear that LDTs met the commercial distribution requirement.
Of particular relevance to ADLM, many of whose members work at state universities, the memo suggested that for certain types of labs — state public health labs and academic medical centers at state universities — the legal persons standard would be impossible to meet as these are considered part of the state and "presumed by definition not to be a 'person.'" That would mean the FDA could not regulate LDTs developed at these facilities even if it were determined it could regulate LDTs developed at labs that did meet the legal personhood standard.
Some of the panelists at the ADLM advocacy session suggested that, in fact, certain kinds of LDTs should be regulated by the FDA. Jones drew a distinction between LDTs developed in clinical labs to meet specific physician and patient needs versus LDTs developed by entities aiming to mass market them and suggested that the FDA should be involved in overseeing the latter variety of tests.
Carmen Wiley, medical director of the clinical laboratory at Spokane Valley, Washington-based Incyte Diagnostics, likewise said that such LDTs should be submitted to the FDA.
Others outside ADLM are also watching the FDA rulemaking process.
Jianqing Bennett, who leads the clinical business unit at mass spectrometry vendor Waters, said that the company is monitoring it "very closely" as it could impact many of its customers in the clinical mass spec space, where LDTs are commonly used.
"It's not super clear in our customers' minds what [FDA] is going to do," she said.
The American Clinical Laboratory Association (ACLA) is also following the agency's efforts, said President Susan Van Meter. ACLA is more favorably disposed toward the VALID Act than is ADLM, but the organization has historically opposed the FDA's efforts to regulate LDTs outside of a legislative process.
Van Meter declined to say if ACLA planned to take legal action if the FDA does attempt to regulate LDTs through rulemaking but said that it had "foundational concerns about the authority of the FDA to regulate LDTs as medical devices."
She said that ACLA continues to believe that legislation like VALID "is the best way to go" in terms of regulating LDTs.
The FDA, perhaps aware of the legal challenges its rulemaking efforts are likely to face, has also said that its preference is for Congress to pass legislation like VALID giving it authority over LDTs.
At the moment, however, the bill appears to have little momentum, particularly in the Senate where one of its primary champions, former North Carolina Sen. Richard Burr, has retired, and another, Sen. Patty Murray, D-Wash., has moved from chairing the relevant Senate committee, the Committee on Health, Education, Labor, and Pensions (HELP), to chairing the Senate Appropriations Committee.
"I would say the chances are probably not very good that VALID will pass this year," Jones said. "We've kind of moved on to FDA and their rulemaking."