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Efforts to Allow FDA Oversight of Clinical Laboratory-Developed Tests Continue in New Congress

The VALID Act has been refiled and the FDA has declared its intent to issue a proposed rule to enable it to oversee LDTs

Should the federal Food and Drug Administration (FDA) have the authority to regulate laboratory-developed tests (LDT)? Advocates in favor of this outcome are working to make FDA oversight of LDTs a reality.

On March 29, HR.2369—the Verifying Accurate Leading-edge IVCT Development Act of 2023 (VALID Act)—was refiled in the US House of Representatives by Representatives Larry Bucshon, MD, (R-IN) and Diana DeGette (D-CO). The 273-page proposal would move LDT oversight to the FDA.

Prior to that, however, the FDA had already announced its intention to issue a proposed rule giving the agency regulatory oversight of LDTs.

“The FDA has continually supported the passage of the VALID Act by Congress,” attorney Charles Dunham IV, a Shareholder at Greenberg Traurig LLP in Houston, told Dark Daily. “In fact, there is speculation that the VALID Act will be attached to the Pandemic and All Hazards Preparedness Act as it moves through Congress.”

Dunham is moderating a legal panel at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, which takes place April 28-26 in New Orleans. The VALID Act and other lab-related legal topics will be discussed by attorneys on the panel.

Charles Dunham IV

“The FDA may not actually proceed with promulgating rules to regulate LDTs if it is concerned it will not be successful in court if the rules are challenged, which would happen,” said attorney Charles Dunham IV (above), a Shareholder at Greenberg Traurig, LLP. Clinical laboratory leaders can learn more from Dunham during a panel discussion at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans. (Photo copyright: Greenberg Traurig LLP.)

Arguments For and Against FDA LDT Regulation of LDTs

Supporters of the VALID Act contend that putting LDTs under FDA regulation will lead to improved patient safety and less review for low-risk tests. Their argument is that LDTs should undergo the same FDA review and approval process as other medical devices.

Hospital laboratory managers and pathologists—particularly in academic medical center laboratories—have largely opposed FDA regulation of LDTs. They prefer to keep the current setup under which lab-developed tests are validated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). They argue that FDA intervention will slow down development of new tests.

In fact, it was academic medical center pathologists who led the fight against the VALID Act in the last session of Congress, as Dark Daily reported in “Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests.” Lawmakers eventually chose not to include the VALID Act in the 2022 year-end spending bill.

In response, an FDA official indicated during the American Clinical Laboratory Association’s (ACLA) annual meeting on March 1 that the federal agency plans to issue a proposed rule to regulate LDTs, BioWorld reported. That rulemaking has not yet emerged. It’s possible the FDA will wait and see what happens in Congress with the VALID Act.

Attorney David Gee, JD, a partner at Davis Wright Tremaine LLP in Seattle, told Dark Daily that a US Supreme Court decision last year concerning the Environmental Protection Agency (EPA) casts doubt on the FDA’s ability to regulate LDTs.

“Some legal experts have suggested that one significant new legal challenge FDA may face is the Supreme Court’s West Virginia v. EPA decision last summer that limited the ability of the EPA to cap power plant emissions by regulation due to the EPA’s lack of explicit congressional authority to do so,” said Gee, who also will appear on the Executive War College legal panel next week.

“The West Virginia v. EPA ruling provides support for those in the clinical lab industry who point to the FDA’s lack of clear statutory authority to regulate LDTs and therefore fundamentally disagree with FDA’s longstanding position that LDTs are medical devices subject to FDA’s authority to regulate,” he added.

Actions Clinical Laboratory Managers Can Take

Clinical laboratory managers who want to share their thoughts about the future of LDT regulation may want to take one or both of the following actions:

  • Contact their representatives in Congress.
  • Find out whether any trade associations they belong to have taken a position on the VALID Act.

Clinical laboratory professionals should monitor the VALID Act’s progress while also paying attention to industry groups and manufacturers that support or oppose the bill.

Doing so will provide a clearer indication of who has the most to gain or lose should the legislation be passed. Pathologists and medical laboratory managers should also remain alert for further efforts by the FDA to issue proposed rulemaking to regulate LDTs. 

Scott Wallask

Related Information:

H.R. 2369 Verifying Accurate Leading-edge IVCT Development Act of 2023

2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management

Clinical Laboratory Improvement Amendments of 1988

Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests

Hillebrenner Says FDA No Longer Waiting on Congress for LDT Regulation

West Virginia v. EPA Decision

Looming Government Shutdown Opens Door for Congress to Possibly Pass Clinical Laboratory Bills

Theranos Whistleblower Tyler Shultz Publicly Denounces LDT ‘Loophole’ that the Disgraced Blood-testing Company Exploited

Legal Fight over Gene Patents in AMP vs. Myriad Case to Be Subject of Oral Hearings at the Supreme Court, Just Months after Its Ruling in Prometheus Case

Both pathology profession and biotech industry have much at stake in how Supreme Court rules in this important case involving the patentability of genes

Legal challenges to gene patents are a high interest topic among pathologists and clinical laboratory scientists who perform genetic testing. Two high profile cases involving gene patents were accepted by the Supreme Court. A ruling was made in one case and the second case is continuing.

The Supreme Court issued a ruling in one case, titled Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Prometheus). The dispute centered upon Prometheus’ method patents to testing for metabolites of the drug thiopurine in patients with gastrointestinal disease.

In a unanimous opinion, the Supreme Court ruled that these patents were invalid. Some medical laboratory scientists believe that the ruling could ultimately result in the invalidation of the even more significant gene patents, including those gene patents at issue in Association for Molecular Pathology, et al. v. Myriad Genetics (Myriad)..

New Ruling Has Huge Significance for Pathology and Lab Medicine

According to a story in CAP Today, in the Prometheus case, the court reasoned that a process of recognizing and reciting a law of nature is not patentable because laws of nature are not patentable.

Gene Patents by psmag.com

This summer, the Supreme Court will hear oral arguments in the case of Association of Molecular Pathology vs. Myriad Genetics. At issue is the patentability of genes. In March, the Supreme Court ruled unanimously against Prometheus in another case involving gene patents. (Image by PSmag.com)

“We have the first clear statement by the Supreme Court—and by a unanimous Supreme Court—that laboratory testing really amounts to nothing more than an observation about the correlation between an analyte and a particular medical condition is not patentable,” stated Jack Bierig, JD, Partner with Sidley Austin in Chicago, in the CAP Today article.

Bierig observed that the key question presented by Prometheus is where to draw the line between a law of nature and an application of the law. “There is a well-known distinction between laws of nature—which are not patentable; and applications of laws of nature—which are patentable,” he stated. “This is the first Supreme Court case that has addressed that question in the context of laboratory testing.”

The ruling overturned the U.S. Court of Appeals for the Federal Circuit (CAFC) decision which upheld the Prometheus patents.

Prometheus Decision May Render Myriad Gene Patent Claims Invalid

Important questions still remain about the patentability of genes. Just six days following the March 20, 2012, ruling in Prometheus, the Court remanded Myriad to the CAFC for reconsideration under the new ruling. In 2011, the CAFC found in favor of Myriad.

The Myriad case originated in 2009 when several plaintiffs, including the American Civil Liberties Union, filed a lawsuit challenging seven of Myriad Genetics’ (NASDAQ: MYGN) patents on the BRCA1 and BRCA2 genes and methods for interrogating the genes.

The question of gene patentability is of critical importance to pathologists, according to Roger D. Klein, M.D., J.D., a molecular pathologist and Chair of the Professional Relations Committee of the Association for Molecular Pathology (AMP). Klein observed in CAP Today that enforcement of gene patents in Myriad has interfered with pathologists’ ability to provide comprehensive interpretations involving multiple diagnostic test procedures. He asserted that the patents have also prevented pathologists from implementing cost-saving algorithms that reduce unnecessary testing.

“It’s the gene patents that are so universal,” agreed Wayne W. Grody, M.D., Ph.D., Professor of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics at the University of California School of Medicine. “We really care much more about the impact of this case on Myriad and other cases that may come later,” stated Grody, who is also President of the American College of Medical Genetics and Genomics.

Biotechnology in a “Minor Panic” Following Prometheus Ruling

According to a story in The Economist, the biotechnology industry is in a “minor panic” at the implications of the high court’s unexpected ruling in Prometheus.

Klein rejects the biotechnology industry’s argument that patent invalidation will jeopardize the advancement of personalized medicine. “I think it will produce tremendous advancement and accelerate progress,” he stated.

John H. Noseworthy, M.D., President and Chief Executive Officer of Mayo Clinic, agreed. “[The new ruling] will favorably impact patient care because it provides broad access to good-quality bedside testing,” he stated in a story published by The Wall Street Journal.

At this point, oral arguments in the Myriad case are scheduled for this summer. In reconsidering the Myriad case, the CAFC may reverse its previous ruling upholding the BRCA gene patents, Bierig speculated. Or, the case may end up in the Supreme Court for final determination.

“I think there’s a chance that the Supreme Court could now rule that the product of the genome is basically a natural phenomenon,” observed Bierig. Klein agreed, suggesting that the Prometheus decision probably renders the Myriad patent claims invalid.

Pathologists and clinical laboratory managers will want to continue to follow the surprising developments in these clinically-relevant patent cases. The Prometheus decision sent a clear message that the Supremes are positioned on the side of the “medical” rather than “commercial” ethic in the area of genetic patents.

For its part, the biotechnology industry may ultimately have to resort to seeking relief through congressional revision of patent law as it pertains to genes. Of course, it can be expected that the clinical laboratory testing profession would be actively educating Congressman should there be consideration of such legislation.

—Pamela Scherer McLeod

Related Information:

For background on the patent cases:

Decisions in Prometheus, Myriad, and Classen Cases Help Clarify Patent Eligibility Requirements for Genetic Lab Tests and Molecular Diagnostics

By Zeus! Prometheus ruling checks patents

Prometheus unsound: America’s Supreme Court wallops the biotech industry

Top Court’s Patent Rejection Alarms the Biotech Industry

World’s Largest Food Company Spends $567 Million to Buy into Pathology Laboratory Testing and Pharmaceuticals

Nestlé says its Prometheus Laboratory acquisition will help it develop products for patients with metabolic conditions and to promote brain health

When it comes to the brave new world of genetics in pathology and clinical laboratory testing, such terms as pharmacogenomics, companion diagnostics, and personalized medicine have been coined to describe the intersection of genetic testing and molecular diagnostics with emerging medical practice. Now the world’s largest food company is putting forth a vision of how genetic testing can inform decisions about the patient’s nutrition.

It was last May when the health-science unit of Nestlé SA, (VTX:NESN) the giant foods company in Vevey, Switzerland, announced its purchase of Prometheus Laboratories Inc., of San Diego, California. The price was $567 million.

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