NEW YORK – As implementation of the US Food and Drug Administration's final rule on laboratory-developed tests (LDTs) continues amidst legal challenges from several industry stakeholders, efforts are also afoot to revive legislative approaches to LDT regulation and diagnostics reform.
Members of Congress are reportedly working on a new bill tackling these issues, and a new organization, the Coalition for Effective Diagnostics (CED), has called on lawmakers to pass legislation revamping diagnostics regulation, including oversight of LDTs.
But while the CED has brought together several stakeholders who in the past have been on opposing sides of these issues, the lab industry and broader medical community remain divided on the path forward.
Composed of the College of American Pathologists (CAP), Mayo Clinic, Roche, Thermo Fisher Scientific, Alexion, and Friends of Cancer Research (FOCR), the CED recently issued a letter to legislators in the House of Representatives and the Senate urging them to pass legislation that would halt implementation of the FDA rule on LDTs and establish "a regulatory framework at the [FDA] uniquely tailored to diagnostic tests."
The group was formed "recognizing that the [FDA] final rule as it exists is unacceptable," said CAP President Donald Karcher. "We are trying to develop legislation that will once and for all provide a proper framework for FDA oversight of these tests."
Karcher said that work is underway in Congress on a draft of such legislation, with Reps. Larry Bucshon, R-Ind., and Diana DeGette, D-Colo., leading the effort. Bucshon, who is retiring at the end of the current Congress, and DeGette, who is widely expected to take a leadership position on the Energy and Commerce (E&C) Health subcommittee in the next Congress, previously sponsored the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which aimed to bring LDTs under FDA oversight while also reforming diagnostics regulation more broadly. Neither Bucshon's nor DeGette's office responded to requests for comment.
Karcher described the draft legislation as a "new version of VALID." The prior version of VALID fizzled out in 2022 as Congress declined to pass the bill, which ran into heavy opposition from many quarters of the lab industry. This set the stage for the FDA's decision to tackle LDT regulation on its own through the notice-and-comment rulemaking process.
Few parties seemed happy with this route, however, including the FDA, which suggested on multiple occasions that it would prefer Congress to take the lead on diagnostic reform and LDT regulation. During an E&C hearing in March, numerous committee members voiced reservations about the FDA's then-proposed rule on LDTs. At the hearing, Rep. Anna Eshoo, D-Calif., ranking member of the E&C Health subcommittee, asked the expert witnesses testifying at the session — Susan Van Meter, president of the American Clinical Laboratory Association (ACLA); Zach Rothstein, executive director of AdvaMedDx; CAP's Karcher; Jeff Allen, president and CEO of FOCR; and Dara Aisner, a professor of pathology at the University of Colorado and representative of the Academic Coalition for Effective Laboratory Developed Tests — whether, if forced to choose, they would prefer LDT regulation via VALID or the FDA's proposed rule. Van Meter, Rothstein, Karcher, and Allen indicated that they preferred a legislative solution like VALID, while Aisner said that she and the Academic Coalition — though strongly opposed to the FDA rule — could not support the VALID Act.
Given this broad dissatisfaction with unilateral FDA action, it is perhaps unsurprising that work on a legislative alternative has begun once again.
FOCR's Allen said that following finalization of the FDA rule, Bucshon and DeGette "were interested in updating some of [VALID's] language."
"There seemed to be a renewed interest on the Hill to potentially revisit legislation in the context of that," he said. "That was the motivating factor for bringing some different organizations together and provide feedback that was requested from several [congressional] offices."
Nick Bath, a partner at law firm Manatt, which helped put together the CED, said that after finalization of the FDA rule, a number of stakeholders reached out to the firm to discuss aspects of the rule they opposed.
"We started convening some meetings to talk [it] through from every stakeholder perspective, including stakeholders who had different and contrasting problems with the rule — ostensibly opposing interests," he said, adding that these discussions identified focusing on a legislative approach to LDT regulation as the most promising way forward.
Another factor driving action around alternatives to the FDA rule is the impending return of President Donald Trump to the White House.
While formation of the CED and the recent work in Congress predate the recent elections, some see a Trump administration as more likely than a Kamala Harris administration to undermine or roll back the FDA LDT rule. As Mark Birenbaum, executive director of the National Independent Laboratory Association (NILA) and the American Association of Bioanalysts (AAB), suggested to 360Dx prior to the election, Trump "may want to make some changes at FDA."
Trump's election in 2016 effectively ended the FDA's efforts to regulate LDTs by guidance. In 2020, in the midst of the COVID-19 pandemic, his administration determined that the FDA would not require premarket review of LDTs without notice-and-comment rulemaking. (The recently issued final rule was produced through notice-and-comment rulemaking, however.)
Bath said that the incoming Trump administration raises the potential volatility around the FDA rule compared to a Harris administration in which "there would have been more continuity."
Legislation could "constrain that volatility very significantly and provide more regulatory certainty going forward," he said. "The uncertainty about the future of the rule, I think, convinces folks more that a statutory alternative that is durable and long term is a much better way to go."
Bath said the approach of the deadlines for compliance with the initial stage of the FDA rule has also focused stakeholders on restarting a legislative approach.
"This is a unique time to strike while the iron is hot before people start making fixed-cost investments in the rule that you can't really roll back or don't want to roll back," he said.
The CED includes organizations that in the past have been on different sides of the debate around LDT regulation. FOCR, for instance, supported both the VALID Act and the FDA rule (though the group has said it preferred a legislative approach like VALID to unilateral FDA action). CAP supported VALID but is opposed to the FDA rule. Mayo, meanwhile, is a member of ACLA, which is opposed to the FDA rule, and has neither formally supported nor opposed VALID. Mayo is also a major academic medical center. Academic medical centers and the Association for Diagnostics and Laboratory Medicine (ADLM), which represents clinical laboratorians at many academic medical centers, have been among the strongest opponents of both VALID and the FDA rule.
Karcher suggested that participation of these three groups within the CED indicates the possibility of finding common ground on the issue of LDT regulation and diagnostics reform.
"We are reaching a point where a legislative package that would satisfy all of [the CED] is coming into focus," he said.
Karcher said that one key component of the new draft legislation is a provision that would exempt from premarket review LDTs produced by a medical center for the care of patients of that center. He expressed hope that this could help bring academic medical centers on board, noting that this has been one of their biggest issues with previous stabs at LDT regulation.
It is unclear whether this will satisfy academic medical centers, however. The current FDA rule includes a similar carve-out, and a similar provision was considered as part the prior version of VALID. In an email, ADLM President Anthony Killeen, professor and vice-chair for clinical affairs, department of laboratory medicine and pathology at the University of Minnesota, Minneapolis, said that ADLM had not joined the CED because it sees that organization's aim as "seeking to advance the VALID Act in lieu of the [FDA's] final laboratory-developed tests rule."
While ADLM shares the CED's "goal of making sure that [LDTs] are safe and effective … we oppose both the VALID Act and the FDA's rule, which is why we are not a member of the coalition," Killeen said. He added that ADLM continues to support overhauling LDT regulation via CLIA modernization as opposed to giving oversight to the FDA.
ACLA's Van Meter declined to say whether her organization had been invited to join the CED but said that it remains "in the same place where we have been for some years now, which is we really do think that Congress needs to step in to craft diagnostics-specific legislation."
"We continue to talk with the committees of jurisdiction and leadership offices and will continue to do so in the next Congress," she said. "We will absolutely be part of any significant bipartisan conversation on Capitol Hill about legislation. We think that is the right direction to go long term. Certainly, it is far preferable to the current FDA LDT regulation."
The CED members represent only a small slice of the lab industry. Manatt's Bath declined to specify which entities were approached about joining but said that the firm had reached out to a wide swath of stakeholders across the hospital systems, health plans, labs, and lab organizations "that had had a prominent voice in the debate in the last Congress, and some of them chose not to participate."
Even within the CED, members are not entirely aligned on the path forward. For instance, while CAP's Karcher highlighted the medical center carve-out as an important addition to the draft legislation, FOCR's Allen questioned whether it is actually necessary.
"I think a number of these institutions have shown that they are able to work through regulatory oversight mechanisms such as New York state and that they are able to have transparency around the performance of their tests," he said. "I think it is something that will continue to be debated in terms of what the logistics are of implementing oversight."
Mayo Clinic did not respond to requests for comment on its participation in the CED.
Changes in Congress will no doubt impact the path of LDT legislation. With Bucshon retiring, the House is losing one of the main architects and supporters of VALID.
"We'll see sort of who takes over the Republican mantle [in the House]," Bath said.
Meanwhile, Rep. Cathy McMorris Rodgers, R-Wash., chair of the House Committee on Energy and Commerce, one of VALID's more powerful opponents, is retiring, while on the Senate side, Sen. Bill Cassidy, R-La., will likely take over as chair of the Senate Committee on Health, Education, Labor, and Pensions (HELP). Cassidy has been skeptical of VALID, expressing reservations during a 2022 HELP hearing discussing the bill. In March, he issued a Request for Information asking for input on diagnostics reform that raised the possibility of handling LDT oversight via updates to CLIA regulations as opposed to giving that authority to the FDA.