With the US Food and Drug Administration (FDA) likely in coming weeks to release its final rule on regulation of laboratory-developed tests (LDTs), Congress has indicated interest in once again taking up oversight of such tests and reforming diagnostics regulation.
This month, US Sen. Bill Cassidy, R-La., issued a Request for Information (RFI) asking stakeholders for input on diagnostics reform. Also this month, the House of Representatives’ Energy and Commerce (E&C) committee held a public hearing on “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.”
According to several observers this rekindled congressional interest stems from concerns, both among legislators and industry stakeholders, with the FDA’s plan to regulate LDTs through rulemaking. The FDA itself has said several times that it would prefer a legislative solution to the LDT question and that it chose to act unilaterally after Congress’ failure in 2022 to pass the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would have created a new single structure for regulating both LDTs and in vitro diagnostics by bringing both under the FDA’s authority.
“I suspect [the congressional activity] is largely driven by the timeline of the FDA’s advancement of its rule,” said Jonathan Genzen, chief medical officer and medical director of automation at ARUP Laboratories. “There are major concerns within constituencies about negative impacts of the proposed rule to public health and clinical laboratories and patient care, and I think that is hopefully escalating to the point where maybe people are taking those concerns seriously.”
Discussing the E&C hearing, Susan Van Meter, president of the American Clinical Laboratory Association, said that from her perspective, there was “pretty strong bipartisan consensus among committee members … that the [FDA] rule is not the right direction.”
“So, we are hopeful that that re-energizes the discussion on legislation,” she said.
The FDA has maintained for more than three decades that LDTs are medical devices that fall under its authority according to the Federal Food, Drug, and Cosmetic Act (FDCA), but the agency has declined to exercise that authority, instead adopting what it has called a policy of enforcement discretion.
More recently, however, the FDA has argued that its policy of enforcement discretion is no longer appropriate given the increasing complexity of LDTs and their ubiquity throughout the healthcare system, including for the diagnoses and management of life-threatening conditions. It has also noted that a number of vendors offer their tests as LDTs as a way of avoiding FDA regulation, even though these tests are marketed to large and diverse customer bases much like traditional IVDs.
In 2014, the agency released a pair of draft guidances in which it said it would require registration of LDTs and premarket approval of certain higher-risk LDTs. The agency received substantial pushback from the clinical lab and diagnostics industries, which questioned its authority over the tests, and two years later, following the election of President Donald Trump, the agency halted its LDT regulation plans.
Following that, Congress began giving the LDT question a closer look, with lawmakers crafting legislation — most notably the VALID Act — that would have given the FDA authority over LDTs. Despite apparent momentum in 2022, VALID ultimately failed to move through Congress, and the following spring, the FDA said it would resume its efforts to regulate LDTs.
This effort has met with pushback from most corners of the clinical lab industry, including parties like ACLA and the College of American Pathologists who had expressed either openness to or support of VALID.
At the recent E&C hearing, a number of committee members also voiced reservations regarding the FDA’s proposed rule on LDTs. Representatives including Brett Guthrie, R-Ky., chair of the E&C Health subcommittee; Anna Eshoo, D-Calif., ranking member of the E&C Health subcommittee; Larry Bucshon, R-Ind., vice chair of the E&C Health subcommittee; and Cathy McMorris Rodgers, R-Wash., chair of the E&C committee, expressed opposition to the FDA rule.
There were indications that this dissatisfaction with the FDA rule could spur Congress to revisit a legislative approach to LDT regulation, with a number of representatives signaling support for this idea. Eshoo also asked the expert witnesses testifying at the session — Van Meter; Zach Rothstein, executive director of AdvaMedDx; Donald Karcher, president of CAP; Jeff Allen, president and CEO of Friends of Cancer Research; 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.
Stakeholders hold firm
Aisner’s opposition to VALID points to the fact that while industry stakeholders are largely opposed to the FDA rule, it has not meaningfully shifted their opinions on VALID. Aisner and the Academic Coalition represent a collection of academic medical center labs, which were among the most vociferous opponents of VALID when Congress last seriously considered the bill in 2022.
Olivia Peck Palmer, president of the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), which also counts many academic medical center labs among its members, likewise told 360Dx that her organization opposes both VALID and the FDA proposed rule.
Meanwhile, ACLA, which represents a number of large commercial labs including Quest Diagnostics and Laboratory Corporation of America, continues to maintain openness to VALID but to advocate for what it believes are needed changes to the bill.
In particular, Van Meter said the organization has issues with VALID’s provisions exempting tests for noncontagious disease or conditions that affect no more than 10,000 individuals in the US annually, and tests developed to diagnose a unique pathology or physical condition of a specific patient or patients if the test isn’t intended for use in more than five patients. The organization is concerned these caps are too low, she said.
Additionally, Van Meter said ACLA would like to see the bill’s technical certification pathway made more expansive.
Beyond VALID
Meanwhile, the RFI recently released by Cassidy’s office suggests that Congress may look outside the VALID framework to address LDTs.
The RFI asks stakeholders for thoughts “specifically addressing the actions Congress should pursue to meet the challenge of ensuring patient access to timely and advanced diagnostics” and lists a series of specific questions for stakeholders to address, including how well the FDA’s medical device framework is working for regulating diagnostics and what updates to CLIA could improve regulation of LDTs.
However, the RFI does not discuss the possibility of FDA oversight of LDTS, either through agency rulemaking or legislation like VALID. Instead, it focuses on whether LDT oversight might be addressed through updates to CLIA regulations. This is the preferred route of some lab groups like ADLM and the Association for Molecular Pathology (AMP), though the US Centers for Medicare & Medicaid Services, which oversees CLIA regulation, has said it supports FDA oversight of LDTs.
Peck Palmer said the Cassidy RFI’s focus on CLIA as a means of updating LDT regulation “suggests that the message ADLM has been presenting and the facts that we have been sharing speaking with these [congressional] offices has been heard.”
“I appreciate the fact that in the RFI, they are asking questions not just about FDA oversight but also about a role for CLIA,” said ARUP’s Genzen. “It’s been my personal belief, and we reflected this in the ARUP public comment letters, that there is a role for CLIA here.”
Cassidy has been skeptical of VALID, expressing reservations during a 2022 Senate Committee on Health, Education, Labor, and Pensions (HELP) hearing discussing the bill and advocating for an amendment introduced by Sen. Tommy Tuberville, R-Ala., that would have exempted LDTs developed at academic medical centers from FDA regulation under VALID.
Electoral implications
Cassidy could be a key player in any congressional efforts around LDT regulation going forward. Currently ranking member on the Senate HELP committee, he could take over as committee chair if Republicans take control of the Senate in this year’s elections. Meanwhile, one of VALID’s primary champions, former Sen. Richard Burr, R-N.C., retired at the beginning of 2023.
Retirements in the House could also impact VALID’s chances of moving forward, particularly if, as seems likely, Congress isn’t able to take it up this year. Bucshon, one of the bill’s most prominent supporters, has said he is retiring at the end of this term. On the flip side, McMorris Rodgers, who played a key role in blocking passage of the bill in 2022, is also planning to retire at the end of this term.
Congressional skepticism toward the FDA proposed rule raises the question of whether legislators might act to block its implementation even if they are not able this year to pass a law like VALID addressing oversight of LDTs. One route would be to attach a “no such funds” rider to future appropriations bills providing funding for FDA. Such a move would prohibit the agency from using its funding to implement LDT oversight, though this would require the support of Sen. Patty Murray, D-Wash., chair of the Senate Appropriations Committee, and a staunch supporter of VALID.
Legal challenges, which many observers see as likely, could also delay implementation of the rule. Van Meter said that while ACLA has not yet made any decisions on potential litigation, the organization “would not be surprised to see legal action.”
“We have long said that we do not believe the FDA has any authority to regulate laboratory-developed testing services as medical devices,” she said.
In a recent blog post, diagnostics consultant Bruce Quinn suggested that a lawsuit over the proposed rule is essentially inevitable.
Quinn added that if Trump wins a second presidential term in November, his administration could end or undermine the FDA rule in a variety of ways, including reversing the rule through the rulemaking process or declining to defend it in court in the event of legal challenges.
The first Trump administration “was hostile multiple times to LDT regulation,” Quinn said, noting that following his election, the FDA withdrew LDT regulation it had been working on in the waning days of Barack Obama’s presidency.
During the COVID-19 pandemic, the US Department of Health and Human Services said the FDA could not require premarket review of laboratory-developed tests without notice-and-comment rulemaking, which removed the requirement that CLIA labs take SARS-CoV-2 LDTs through the FDA’s Emergency Use Authorization process.
In 2020, an internal memo from Robert Charrow, then general counsel at HHS, laid out several legal challenges FDA rulemaking on LDTs might face and expressed skepticism that the agency effort would succeed, particularly with respect to oversight of LDTs developed at state public health labs and state universities.
