House Committee Wrestles With Lab Test Regulation

Members of a House committee mostly agreed that laboratory-developed tests need more oversight, but were divided Thursday on how best to approach the topic.

The issue at hand was a proposed rule from the FDA that would require medical facilities that use lab tests developed in-house to get the tests approved by the FDA, something they currently aren't required to do.

"Instead of capitalizing on advancements in precision medicine, and exciting genetic technologies to help patients, the FDA has proposed dramatically increasing the regulatory burden on a subset of diagnostic tests," Rep. Cathy McMorris Rodgers (R-Wash.), chair of the House Committee on Energy and Commerce, said during a subcommittee hearing on the issue. "These regulations extend far beyond any of the legislative proposals that Congress has considered."

"Under the proposed rule, laboratories will incur significant costs to come into compliance," she continued. "New administrative and clerical burdens along with oppressive submission fees will be a substantial drain on our labs' limited resources." For example, a lab that offers 1,000 laboratory-developed tests (LDTs) will likely be required to submit 250 sample tests in a year as proof of proficiency, "something that is likely impossible for the lab to do and for FDA to review in a timely manner."

But Rep. Frank Pallone (D-N.J.), the full committee's ranking member, said he was in favor of the FDA rule. "Physicians have years of training and the best interests of their patients in mind," he said. "By not providing oversight of LDTs, we're failing them by not ensuring they can trust the tools that they have to guide their patient counseling and develop effective interventions. So the proposal is an important step to help ensure that healthcare decisions are made based on test results that patients can reliably trust."

Still other committee members wanted to see a different solution -- namely, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, a bipartisan bill that would put stricter approval requirements on higher-risk tests. "While the VALID Act, like the LDT rule, assumes that diagnostic regulation is in need of change, it takes a much different approach," said subcommittee vice-chair Rep. Larry Bucshon, MD (R-Ind.), the act's chief sponsor.

For one thing, all existing LDTs will be grandfathered in for approval, he explained. In addition, new tests would be categorized as low-, medium-, or high-risk, and all low-risk tests would not require FDA pre-market approval.

Asked by Rep. Anna Eshoo (D-Calif.), the committee's ranking member, which they preferred -- the FDA's proposed rule or the VALID Act -- most witnesses chose the latter. "We strongly support the VALID Act," said Zach Rothstein, JD, executive director of AdvaMedDx, a division of the medical device trade group AdvaMed.

Donald Karcher, MD, president of the College of American Pathologists, agreed. In his opening testimony, he said that the VALID Act "would establish a reasonable and balanced regulatory framework that would ensure quality testing for patients and minimize the regulatory burden on labs ... Further, it places guardrails around LDT regulation to prevent duplicate of existing [federal] requirements and infringement on the practice of medicine."

But Dara Aisner, MD, PhD, who represented the Academic Coalition for Effective Laboratory Developed Tests, begged to differ. "Those I represent don't support VALID Act; we believe there's a way to find middle ground," said Aisner, who is also a professor of pathology at the University of Colorado in Aurora. "One pathway is to center on proficiency testing. A pathway that asks laboratories to undergo proficiency testing prior to launch achieves the endpoint without the burden. There are other options."

Later in the hearing, she noted that a 2018 study published in JAMA Oncology found that out of nearly 7,000 proficiency testing responses, both LDTs and FDA-approved tests -- known as "companion diagnostics" -- had similar, near-100% accuracy. "There is ample data from decades of testing demonstrating that labs perform at an exceptionally high level. The idea that there's no post-market review doesn't account for proficiency testing."

Susan Van Meter, president of the American Clinical Laboratory Association, expressed similar sentiments in her response to a question from Rep. Jay Obernolte (R-Calif.). "The FDA offers a de minimis number of examples," of problems with LDTs, she said. "We're very concerned about the prejudicial language that the agency uses to describe laboratory-developed test services and the examples of problematic LDTs that it offers -- frankly, most of those are not based in scientific literature."

Thursday's hearing was the latest development in the long history of attempts at LDT regulation, as noted in the committee's hearing memo. Starting in 2006, the FDA published draft guidance for a specific subset of LDTs. However, the FDA never finalized this guidance. Instead, the agency held a public meeting in July 2010 to discuss more comprehensive oversight.

The FDA issued draft guidance on LDT regulation in 2014, officially notifying Congress of its intent to begin regulating LDTs. In response to this notification, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing in 2016. This was followed by an FDA white paper in 2017, in which the agency said it would not be issuing final guidance to give Congress a chance to legislate the matter.

In 2020, HHS rescinded materials related to the FDA's premarket review of LDTs, "determining that the FDA may not require pre-market review of LDTs absent a formal notice and comment process," the memo noted. Finally, last year, the agency announced its proposed rule.

In the meantime, Congress was working on its own legislation, including the VALID Act. In fact, Eshoo noted, "this is the sixth year for Congress to be grappling with the VALID Act, so we have not acted validly."

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