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Some Stakeholders Not on Board With Draft Bill on New Dx Regulatory Framework

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This article has been updated to note that the College of American Pathologists, in April 2017, sent a letter to legislators stating its opposition to a draft version of the Diagnostics Accuracy and Innovation Act.

NEW YORK (GenomeWeb) – A group of 17 organizations including academic medical centers, physician and pathology groups, and the third largest full-service lab in the country have written to legislators to indicate their disfavor for a draft bill to update diagnostics regulations.

"The Diagnostics Accuracy and Innovation Act (DAIA) discussion draft's approach to laboratory-developed testing procedures is not appropriate as it consequently generates a new regulatory environment that would overburden and stifle clinical laboratories and medical professionals' ability to provide laboratory testing to patients," wrote 17 organizations in a letter to House Committee on Energy & Commerce leaders Greg Walden and Frank Pallone, and to Senate Committee on Health, Education, Labor & Pensions leaders Lamar Alexander and Patty Murray.

DAIA was publicly released for stakeholder input in March 2017 and fashioned closely after a framework developed by the Diagnostic Test Working Group in 2015. It proposes to create a new, in vitro clinical test (IVCT) category, which comprises both test kits and lab-developed tests. The FDA would be in charge of developing and validating an IVCT, while the Centers for Medicare & Medicaid Services would continue its historic role of overseeing the performance of the developed IVCT within labs that are certified under the Clinical Laboratory Improvement Amendments. The states will continue to have jurisdiction over the interpretation of IVCT results by a medical professional.  

Among the signatories to a letter urging legislators not to move ahead with this draft bill are the Association for Molecular Pathology; the American Medical Association; the American College of Medical Genetics and Genomics; several academic medical centers, such as Vanderbilt University Medical Center, Columbia University Irving Medical Center, and University of Chicago Medical Center; and one large commercial diagnostics lab, Bioreference Laboratories, a subsidiary of Opko Health.

Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) have been drafting versions of this bill with stakeholders for a number of years, giving hope to some that DAIA would settle the longstanding regulatory standoff between the FDA and the lab industry over the regulation of lab-developed tests (LDTs). Lab-developed testing procedures have had to meet the federal regulatory standards CLIA, but as labs have evolved in terms of technology and business practices, the FDA has long felt that these standards aren't sufficiently protecting the public health.

Even though most labs were loath to come under FDA oversight, the agency had been pushing to advance a framework to bring all LDTs under its purview, until the Trump Administration took office in 2016. Trump-appointed FDA Commissioner Scott Gottlieb has placed the responsibility of advancing a new regulatory framework for diagnostics in Congress's hands. In turn, many in the lab industry have fixed on DAIA as the best vehicle for crafting regulations that the lab industry can live with.

"The American Clinical Laboratory Association supports legislation as the path for reform and believes DAIA is a good starting point for those legislative discussions," a spokesperson for the top laboratory interest group said. She added that stakeholders have been participating in legislative discussions since 2014, and hope to continue this engagement "so that reform can be successfully enacted in 2018."

In May, ACLA and more than 70 stakeholders in the life sciences community wrote to leaders in the House E&C and the Senate HELP, urging for a legislative update to diagnostics oversight with DAIA as a starting point. "Stakeholders have never been more aligned on the need for diagnostics reform than we are," the groups, led by ACLA, American Cancer Society Cancer Action Network, and AdvaMed wrote in the letter.

Policy experts knowledgeable of the efforts to advance DAIA say the working bill has support from a broad swathe of the lab industry. Joining ACLA in signing the May letter were large reference labs Quest Diagnostics, the Laboratory Corporation of America, and ARUP; diagnostic manufactures Abbott and Roche Diagnostics; and providers of lab-developed tests, such as Myriad Genetic Laboratories and Genomic Health.

However, two prominent pathologist groups, AMP and the College of American Pathologists, were not listed among the supporters. And despite being a member of ACLA, BioReference Laboratories also didn't sign on to that letter.

"AMP opposes DAIA," said Mary Steele Williams, executive director of AMP. "Given the reference to DAIA in the letter [in May], we had concerns that the ACLA letter would be used to advocate for DAIA or imply that the co-signers of the letter also endorse DAIA."

David Liss, VP of external relations at BioReference, said the company also didn’t sign that earlier letter because the company would be concerned about any act that prevents laboratories from developing testing procedures based on the latest science and being able to bring those to patients. "Laboratory medicine has a record of extraordinary safety because of CLIA, and other regulators, including state departments of health such as New York’s, and certifying bodies such as CAP," Liss said. "What laboratories do is the practice of medicine. We should be well regulated by agencies experienced with how trained professionals practice medicine."

CAP, in April 2017, sent its own letter to Bucshon and DeGette stating its opposition to the draft bill. "Our organization does not believe the DAIA discussion draft is necessary in regulating LDTs and would only create a new and complex regulatory environment that would overburden clinical laboratories and medical professionals in their course of carrying out quality laboratory testing for patients," CAP wrote, advocating for an approach that leverages existing structures.

Both AMP and CAP have advanced their own regulatory proposals and shared them with legislators in 2015, while the House E&C was already giving serious consideration to the framework from the Diagnostic Test Working Group. Both AMP and CAP favor updating regulations through the existing system laid out under CLIA, and envision a far more limited role for the FDA in regulating laboratory tests than what the Diagnostic Test Working Group, and by extension DAIA, proposes.  

Last year, when Bucshon and DeGette circulated a version of DAIA for stakeholder input, AMP took issue with the central premise of the bill: IVCTs. The bill seeks to create a common regulatory framework for diagnostics by advancing the IVCT category, comprising both IVD kits and LDTs. 

However, AMP wrote that "a common regulatory pathway is inappropriate and unattainable," because IVD kits are manufactured to be performed in different labs by individuals with varying skills, while laboratory-developed test procedures (LDPs) are developed and performed in one lab by board-certified medical professionals. "The central role of the medical professional throughout the entire test process minimizes the risks of LDPs and ensures their safe and effective use," AMP told legislators. 

AMP also objected to the extent to which the FDA could exercise oversight powers over LDPs under DAIA, and based on this fundamental disagreement, indicated it could not support many provisions in the draft bill. In the latest letter to Congress, AMP and co-signatories reiterated these positions and recommend again that lawmakers update regulations using the existing CLIA framework.  

"We stand united in support of modernizing the oversight framework for high-complexity clinical laboratory-developed testing procedures but primarily through reform of the Clinical Laboratory Improvement Amendments," wrote AMP and the co-signees. They noted that a CLIA-centric approach would achieve the most cost-effective, streamlined, and flexible regulatory system, allowing healthcare professionals to offer the most up-to-date tests.

These organizations also objected to the proposal within DAIA to create a new FDA center to regulate IVCTs. Such a center "is not only unnecessary but also unrealistic given the current budgetary restraints on the agency," they wrote. Complying with an entirely new FDA regulatory regime could increase costs for labs at a time when they're already facing "deep cuts" to Medicare payment follow implementation of the Protecting Access to Medicare Act of 2014, they said.

While this group would like to see a far limited role for the FDA in any new diagnostic regulatory regime, they seem to agree on this point with the agency. In providing technical assistance on DAIA, the FDA also told lawmakers that creating a brand new center would be costly and unnecessary. 

Generally, the agency expressed support for the draft bill as long as "it does not impose unreasonable barriers for FDA to take action to address problematic tests, or unnecessary costs or delays of implementation." However, the FDA also took this opportunity to pitch the idea of a precertification program that could ensure that test developers have the processes in place to develop analytically and clinically valid tests.

The program would factor in the entity, technology, and clinical context to assess which tests are eligible for this pathway, and once an entity (a lab or test developer) has gained precertification for a category of tests, other tests in that category would not be subject to premarket review.

AMP's Williams noted that the organization is tracking the agency's implementation of a precertification program for digital health products, but currently does not have a position on FDA's proposal to extend such a scheme for diagnostics. AMP has also shared its oversight modernization proposal with FDA.

Meanwhile, the agency has also been working to streamline the regulatory pathway for diagnostics that labs voluntarily take through the agency. For example, last year the FDA authorized Memorial Sloan Kettering Cancer Center's MSK-IMPACT next-generation sequencing panel as a Class II, moderate-risk device, and simultaneously made the New York State Department of Health a third-party reviewer of IVDs, including similar tumor profiling assays. 

This allows other labs to apply to the FDA for 510(k) clearance — a less onerous path than premarket approval — for their tumor profiling NGS panels. But if the test already has approval through the NYSDOH, sponsors can submit that application to the FDA and ask the state regulator to forward its review documents and recommendations.

"Conditional approval of LDPs developed by laboratories with expertise in a specific area has been a successful approach used by NYSDOH," Williams said. "AMP believes that this kind of concept could be employed by CLIA to effectively ensure the accuracy and precision of LDPs."

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