Congressional Hearing on LDTs: Split on FDA Regulation but Support for VALID

April 1, 2024By Ana Loloei & Jeffrey N. Gibbs

On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.”

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing the hearing, made their views clear: “FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input. The proposed rule extends far beyond the scope of any legislative proposals and would threaten access to reliable tests for children and patients with rare diseases.” They believe any regulatory oversight for laboratory developed tests (LDTs) should be mandated by Congress, rather than the Executive Branch.

The majority of witnesses, along with several of the Congressional members, agreed that legislation is the appropriate path to regulating laboratory developed tests.  FDA, which was not invited to participate, would surely have concurred.  This seems to have been the outcome that many lawmakers desired. Specifically, Representatives Bucshon (R-IN), Eshoo (D-CA), DeGette (D-CO), and Carter (R-GA) asked targeted questions seeking to get witnesses to go on the record supporting legislative efforts, in lieu of rulemaking by FDA. Congress has on multiple times considered, and failed to enact, LDT legislation (see here and here). Nevertheless, lawmakers appeared eager to pursue a legislative solution and try to force stakeholders back to the table.

The FDA proposed rule elicited some strong criticism. Susan Van Meter, the president of the American Clinical Laboratory Association, said, “FDA is poised to reshape the regulation of laboratories by bypassing Congress and unilaterally imposing medical device regulation on the professional testing services that laboratories provide.”  She testified that applying such an approach to laboratories is inappropriate and does not strike the right balance between maintaining patient access and encouraging diagnostic innovation.  Multiple witnesses warned that FDA’s rulemaking would inhibit the ability of labs to offer innovative tests due to the high cost and delays of going through the FDA review process.

Donald Karcher, president of the College of American Pathologists, said most LDTs are developed and used for patients that are cared for in the hospital or health care network where the lab is located, which enables the lab and pathologists to interact directly to adequately assess the clinical validity. He emphasized that FDA regulatory oversight should focus on those tests that pose the highest risk to patients.

Several witnesses also noted the lack of grandfathering provisions for tests already on the market in the proposed rule, something that was included in the VALID Act.  FDA could, of course, insert grandfathering in the final rule; it remains to be seen if that will happen.

Committee Chair Rodgers expressed her concerns that FDA regulation of LDTs would substantially increase the regulatory and financial burden on labs, causing them to stop offering many tests, such as those that are used in oncology and cell and gene therapies. Van Meter also testified that this is even more consequential for pediatric patients, small patient populations and patients with rare diseases.  These are areas where “revenue is modest,” she said.

Zach Rothstein, executive director of AdvamedDx, noted that the VALID Act included certain provisions that are designed to provide regulatory certainty and encourage the development of innovative diagnostics (e.g., technology certification program). Rothstein emphasized that the VALID act has specific provisions related to postmarket modifications and mitigation measures for bringing the tests down to a lower risk test.

A fundamental divide is over whether LDTs and in vitro diagnostic products (IVDs) should continue to be regulated differently or if legislation can be crafted and enacted that will cover both types of products. While most witnesses appeared to support the legislative approach, Dara Aisner, Medical Director at Colorado Molecular Correlates Laboratory representing the Academic Coalition for Effective Laboratory Developed Tests, said that LDT developers and IVD manufacturers are not in the “same playing field” as they are “not playing the same sport,” and that they should not be held to the same standards.  Years of debate have shown that no legislative proposal will be palatable to all stakeholders.

Rothstein also expressed concerns over LDTs current regulatory status, and said that FDA’s proposed rule clarifies that IVDs, including those developed by a laboratory, are medical devices. Rothstein further asserted that a modernized regulatory framework for all diagnostic tests should be overseen by FDA, and the focus should be on whether the tests work rather than “where they are developed.”  Jeff Allen, President and CEO of Friends of Cancer Research, also expressed support for FDA regulation, saying that without FDA oversight there’s no way to know how many LDTs are available.

Consistent with our own analyses, (see here and here), both Representatives and witnesses expressed significant concerns about FDA’s underestimating the number of available LDTs and the number entering the market each year.  Karcher testified that it is not clear how this assessment was done and that even CAP doesn’t have the capability to gather such information. The majority of witnesses believed the number is much higher.  FDA’s understating the number of LDTs would result in FDA understating the total costs of complying with a final rule.

As we previously blogged, the draft final LDT rule is with OMB’s Office of Information and Regulatory Affairs (OIRA) for review. So far, OIRA has held or is scheduled to hold at least eleven meetings with stakeholders on LDT issues, including some that testified on March 21. Whether these meetings will lead to changes in the rule is unknown.

The March 21 hearing did generate public support for VALID.  But given Congress’ track record on VALID and its limited ability to tackle any substantive issues, it would be surprising if Congress sprang into action, even after a final rule is issued.  At this point, litigation – not legislation – is the more likely next step after finalization.