Fighting the FDA’s Final Rule on LDTs

The U.S. Food and Drug Administration (FDA)’s final rule on laboratory-developed tests (LDTs)¹ has not come quietly into existence. It has been the subject of objections, queries, and challenges from a range of legal and laboratory experts, including professional organizations,² trade associations, and even members of Congress. Most recently, the Association for Molecular Pathology (AMP) filed an 83-page lawsuit calling for the rule to be vacated and its enforcement by the FDA prohibited.³ The suit builds on those already filed by placing particular emphasis on molecular pathology practice, including precision medicine, and by analyzing and countering in detail the FDA’s interpretation of the laws that govern its authority.

AMP’s CEO, Laurie Menser, sat down with Lab Industry Advisor to explain the lawsuit, the reasoning behind it, and the ways clinical laboratory professionals can get involved.

Q: Why did AMP file this lawsuit against the FDA?

A: AMP remains very concerned about the wide-sweeping and long-lasting consequences the FDA rule will have for our members and patients across the country. We filed this lawsuit to ask the court to overturn the FDA rule given the agency’s lack of statutory authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine.

The FDA rule threatens the ability of professionals in clinical laboratories—including many academic medical centers, reference laboratories, and community health systems across the country—to create, adapt, and modify LDTs to meet patients’ needs, account for supply chain issues, reflect advances in scientific understanding and practice standards, and improve performance characteristics.

AMP is committed to protecting the interests of our members and the patients we serve. This action was taken after months of careful consideration of the potential consequences of this drastic policy change on patient care and the practice of molecular pathology. We are confident in our position and look forward to the next steps in this process.

Q: What key things do you want laboratorians to know about the suit?

A: For decades, LDTs have led to significant clinical advancements in rare and infectious diseases, human genetics, oncology biomarker testing, and more. Often created in response to unmet clinical needs, they are instrumental for early and precise diagnosis, disease monitoring, and treatment guidance. Importantly, Congress has not given FDA the authority to regulate LDTs as manufactured products, but instead delegated that authority to the Centers for Medicare & Medicaid Services (CMS) to regulate these procedures as laboratory services under the Public Health Service Act.

Many laboratories and clinical lab professionals will be forced to stop providing vulnerable patients with cutting-edge medical care and will abandon ongoing efforts to develop new LDTs that could diagnose fast-moving diseases quickly and mitigate emerging public health threats. Others will risk bankruptcy or opt to close their laboratories in response to the cost of complying with FDA’s new mandates—leading to significant job losses in the pathology profession, driving future doctors into other fields, reducing training opportunities, and further exacerbating the ongoing shortage of pathologists in the United States.

In particular, smaller laboratories aiming to survive FDA’s regulatory overreach—especially those serving isolated, rural, or disadvantaged communities—may not have the financial wherewithal to continue to practice. These labs will be faced with challenging decisions regarding whether to close their operations or consolidate with the few national laboratory conglomerates and private equity firms that can afford the extraordinary cost of FDA compliance. Consequently, competition among laboratories—and the innovation it spurs—will be greatly hampered.

Ultimately, patients will pay the price—not only because recouping the final rule’s massive compliance costs is likely to require significant price increases for every procedure a laboratory performs, but also because many patients will face care delays and other barriers to accessing testing for diseases or conditions that could have been prevented, diagnosed, and treated far sooner if new LDTs had been developed and made available. It is imperative that the courts act to prevent the catastrophic consequences that FDA’s final rule will unleash.

Q: How does AMP’s lawsuit relate to the American Clinical Laboratory Association (ACLA) suit also filed against the FDA over LDT regulation?

A: There are a few important differences between AMP’s lawsuit and that of the ACLA.⁴ The memberships are different; AMP is a medical professional society that represents individuals, whereas ACLA is a trade association that represents laboratories. As a result, AMP’s complaint highlights the FDA’s encroachment on the practice of medicine, which affects individuals to a far greater extent than the laboratories in which they work. AMP chose to file separately because the needs of our members are unique and independent of those organizations represented by ACLA. Our arguments, although similar, reflect these differences in representation.

Recently, both cases were consolidated for briefing and a decision in a single proceeding in the U.S. District Court for the Eastern District of Texas.⁵ That ensures that the judge will consider both parties’ perspectives on the LDT rule before issuing his decision.

We hope to receive relief from the court as soon as possible. The briefing schedule will be complete by the end of the year and we hope to have our case heard in the first quarter of 2025.

Q: Why should LDTs not be regulated by the FDA as medical devices?

A: LDTs are essential medical procedures that are designed, developed, validated, performed, and interpreted by highly trained medical and scientific experts in highly regulated clinical laboratories. They are protocols and, as such, differ vastly from medical devices. LDTs are not manufactured, packaged, nor commercially distributed as medical devices.

These tests are already highly regulated through the existing CMS Clinical Laboratory Improvement Amendments (CLIA) program.⁶ This program has successfully run for nearly 40 years and has led to hundreds of thousands of safe and effective tests on the market.

Q: AMP proposes to update CLIA to help ensure the quality and reliability of LDTs. How would this differ from the FDA’s regulations?

A: AMP has long maintained that the best approach to ensuring the continued development of accurate and reliable LDT procedures—and the correct use, precise interpretation, and proper application of molecular test results—is through modernizing the current CLIA regulations. AMP’s legislative proposal to update CLIA builds on its existing oversight framework and provides enhancements where necessary to provide assurances of test quality.⁷

Specifically, it will enhance testing quality and transparency in the following ways:

• The legislation requires the US Secretary of Health and Human Services (HHS) to develop minimum levels of standards for analytical and clinical validity.
• Laboratories will need to provide summary information about their tests upon request via a standardized format established by the Secretary of HHS so that inspectors have the opportunity to review information about any given test’s analytical and clinical validity.
• The US Secretary of HHS will develop standards and processes to ensure that laboratory inspectors are appropriately trained to inspect and evaluate not only laboratories, but also all examinations and procedures that fall within the inspector’s responsibilities.
• The number of tests subject to standardized proficiency testing will increase. For lab tests without a proficiency testing program, our proposal requires quarterly evaluation via an alternative assessment approach.
• With input from the public and the Clinical Laboratory Improvement Advisory Committee, it will create requirements that are specific to laboratory-developed testing procedures that have elements that do not allow for interlaboratory comparisons and are not well suited to proficiency testing programs.

Under CMS, CLIA allows for the use of third-party accreditation organizations to ensure that all clinical laboratories are complying with CLIA requirements. These organizations enlist experts to support their operations and accredit labs in certain specialties and subspecialties. AMP’s proposed legislation continues the successful role of third-party accreditation organizations, ensuring that there are sufficient personnel to verify the quality of all clinical laboratory testing. Importantly, the Secretary has existing authority to collect fees related to administrating Section 353 of the Public Health Service Act.⁸

Q: What can laboratorians or lab leaders do to support AMP’s efforts?

A: If you or your organization is interested in supporting AMP, there are a few different ways to help.

1. Join AMP to help shape the future of the molecular diagnostics field.
2. Educate yourself—learn more about AMP’s position on the regulation of LDTs.⁹
3. Get involved—serve on one of AMP’s volunteer committees, working groups, or task forces.
4. Engage your colleagues and community. Encourage your colleagues to join AMP, educate individuals on how this rule will impact your practice and patient care, and participate in our local public policy efforts. AMP is currently surveying the clinical lab community on how the FDA’s final LDT rule impacts them.
5. Provide financial support; AMP is a 501(c)(3) nonprofit organization and can accept donations from both individuals and companies.

AMP will continue to advocate for a more effective and efficient legislative framework that supports innovation while ensuring high-quality patient care. Our proposal to modernize the current CLIA regulations is a key part of this effort and we believe it offers a better path forward than the FDA’s final rule.

References:

1. 21 CFR Part 809. Medical Devices; Laboratory Developed Tests. Federal Register. May 6, 2024. https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf.
2. American Society for Clinical Pathology. ASCP Supports Legal Challenges to the FDA’s LDT Rule. September 11, 2024. https://www.ascp.org/news/news-details/2024/09/11/fda-s-legal-challenges-to-ldt-rule-mount–ascp-to-join-lawsuit.
3. Association for Molecular Pathology (AMP) et al. v. United States Food and Drug Administration (FDA). August 19, 2024. https://www.amp.org/AMP/assets/File/advocacy/AMPvFDA_Complaint_8.19.2024.pdf.
4. American Clinical Laboratory Association (ACLA) et al. v. United States Food and Drug Administration (FDA). May 29, 2024. https://www.acla.com/wp-content/uploads/2024/06/ACLA-LDT-Complaint.pdf.
5. US District Court for the Eastern District of Texas. Association for Molecular Pathology et al v. United States Food and Drug Administration et al Case electronically transferred to Eastern District of Texas – Sherman Division. September 10, 2024. https://dockets.justia.com/docket/texas/txedce/4:2024cv00824/232820.
6. Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). September 19, 2024. https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments.
7. Association for Molecular Pathology. Draft Legislation to Modernize the Clinical Laboratory Improvement Amendments (CLIA). https://www.amp.org/AMP/assets/File/advocacy/Amendments%20to%20CLIA%20modernization%20legislative%20text%2011_7_23%20FINAL.pdf.
8. United States Code. Public Health Service Act, Section 353. https://www.cdc.gov/cliac/docs/addenda/cliac0910/Addendum-C_Yost.pdf.
9. Association for Molecular Pathology. Regulation of Laboratory Developed Testing Procedures (LDPs). https://www.amp.org/advocacy/laboratory-developed-testing-procedures-ldps11.