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Draft of 21st Century Cures Legislation Addresses Device Reforms, but Silent on LDTs

NEW YORK (GenomeWeb) – A nearly 400-page draft version of legislation aimed at improving the way new treatments and tests are developed and delivered in the US contains numerous proposals to modernize clinical trials, improve data-sharing efforts, and streamline efforts within public health agencies.

However, under a section entitled "Modernizing regulation of diagnostics," the legislative suggestions are yet "to be supplied," according to the draft document that the House Energy & Commerce Committee released yesterday. The legislative blueprint was crafted under the 21st Century Cures Initiative, led by Rep. Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) after eight hearings and with substantial input from a broad range of stakeholders over several months.

The Personalized Medicine Coalition commended the committee on releasing such a comprehensive bill that emphasizes improvements in patient care. "The breadth and depth of the legislative discussion draft indicates that the Committee gave serious consideration of how legislation could support personalized medicine and innovation," Amy Miller, executive VP of the PMC, told GenomeWeb. "In particular we are pleased that the committee recognized the importance of innovative clinical trial designs for the future of healthcare, the need for incentives for therapy development for unmet, complex, and orphan needs, and recognized that improvements to the regulatory landscape are necessary to support innovations."

However, the legislative language in the draft doesn't directly address diagnostic regulation or mention LDTs. This is conspicuous given the ongoing tension within the life sciences industry regarding the US Food and Drug Administration's draft plans for regulating laboratory-developed tests (LDTs). Although, according to a white paper accompanying the draft legislation, it seems committee members are working on it.

"Following FDA's proposed guidance altering the regulatory landscape for review and oversight of laboratory-developed tests, a broader conversation about the need to modernize the regulation of diagnostics has reached a fever pitch," the legislators wrote in the white paper. "The committee is encouraged by stakeholder efforts to build a consensus around what a modern framework should look like and is working toward the inclusion of such a proposal."

Groups that had provided input to Congress expect legislators in the 21st Century Cures Initiative to weigh in on the topic of LDT regulation and address ways to accelerate development of molecularly targeted precision therapies.

"LDTs and in vitro diagnostics, generally, were mentioned in a white paper that accompanied the draft legislation as an area the committee still hopes to address," Alan Mertz, president of the American Clinical Laboratory Association, told GenomeWeb. "ACLA has consistently said we are willing to work with the committee, but we shouldn't begin with the FDA's misguided proposal that would double regulation and costs all while creating barriers for patient access to clinical laboratory services, results that we view as contrary to the 21st Century Cures Initiative."

In the absence of concrete legislative proposals from Congress on this front, speculation will continue as to whether FDA has statutory authority over LDTs. Many in the lab industry assert that Congress never granted FDA the legal authority to regulate labs, and instead created a separate set of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to place lab oversight under the aegis of the Centers for Medicare & Medicaid Services.

Mertz said as much at a Congressional hearing in September and the group submitted comments to the 21st Century Cures Initiative outlining its objections to FDA oversight of LDTs. Meanwhile, stakeholders supportive of FDA oversight of LDTs, maintain that through the Medical Device Amendments of 1976 (MDA), Congress granted the agency broad authority to regulate such tests.

In a recent interview with GenomeWeb, John Conley, an intellectual property and civil litigation expert at Robinson Bradshaw & Hinson, said that Congress could once and for all end the speculation about whether or not it intended to give the FDA oversight power over LDTs. "Congress could resolve this problem tomorrow," Conley said. "They could resolve this question of congressional intent in CLIA versus the MDA."

Although the legislators have yet to address LDTs, the draft legislation contained several sections dedicated to devices. For example, in one section, entitled "Medical device reforms," legislators suggested allowing FDA to use accredited third parties to certify manufacturing changes that don't alter the underlying technology of the device. They have specified that "valid scientific evidence" backing a medical device can be derived from clinical registries, case histories, as well as peer-reviewed, published data.

The "medical device reforms" section includes language that would allow labs marketing Class I devices to simply provide notification to FDA before commercialization. Moreover, legislators have proposed to expand the humanitarian device exemption (HDE) to include devices that address diseases affecting more than 4,000 individuals annually in the US. At a public meeting on LDT regulation earlier this month, stakeholders complained the terms for an HDE – which exempts labs from having to submit clinical effectiveness data on a device – were too narrow.

The draft legislation would also create a category of breakthrough devices, similar to the breakthrough designation that FDA currently grants to innovative drugs in areas of medical need. The proposed pathway would facilitate expedited review and accelerated approval mechanisms for devices with breakthrough status. Legislators are also working on language that would stipulate that once FDA approved, a breakthrough device would also have Medicare and Medicaid coverage.

One section seeks to clarify the law on research-use-only labeled medical testing products – a topic on which the FDA has issued a controversial guidance. Specifically, the lawmakers note that the FDA cannot consider an RUO-labeled medical test misbranded and hold the manufacturer responsible if the end user is marketing the test in a non-research setting.

Finally, legislators also have yet to supply language in a section in the draft legislation entitled "precision medicine." However, in the white paper, legislators note the need for data-sharing efforts that move healthcare providers and researchers beyond siloed systems. Toward this end, Rep. Michael Burgess (R-Texas) is working on developing a proposal for a national interoperable health information infrastructure. The committee said it would support "a meaningful, workable proposal" on this topic.

Similar to the PMC, AdvaMed commended the lawmakers for releasing the draft legislation for discussion. However, the group representing device manufactures said they were still reviewing the many proposals in the legislation.