By Andy Lundin
Summary: The Association for Molecular Pathology (AMP) filed a lawsuit against the FDA for its new rule regulating laboratory-developed tests (LDTs) as medical devices, advocating instead for modernizing CLIA regulations to better ensure test quality and foster innovation.
Takeaways:
- Legal Challenge to FDA’s Authority: AMP argues that the FDA lacks the authority to regulate LDTs as medical devices and contends that this rule could severely disrupt patient care and stifle innovation in the field.
- Support for CLIA Modernization: AMP believes that updating the existing CLIA regulations is a more effective, streamlined approach to ensuring the accuracy, reliability, and appropriate utilization of LDTs.
- Long-Term Impacts: AMP warns that the FDA’s rule could lead to significant job losses, reduced access to advanced diagnostics, and exacerbate the shortage of pathologists, urging the Court to prevent these potential consequences.
The Association for Molecular Pathology (AMP) has taken a step to protect the integrity of laboratory-developed tests (LDTs) by filing a lawsuit challenging the U.S. Food and Drug Administration’s (FDA) new rule that seeks to regulate these tests as medical devices under the Federal Food, Drug, and Cosmetic Act.
The lawsuit argues that the FDA lacks the authority to regulate LDTs in this manner, and instead advocates for modernizing the existing Clinical Laboratory Improvement Amendments (CLIA) regulations as a more effective approach to ensuring test quality and supporting continued innovation.
“Modernizing CLIA is the most streamlined, flexible, and cost-effective pathway forward for updating laboratory testing requirements,” says Laurie Menser, CEO of AMP, adding that this approach would maintain patient access to high-quality testing while also supporting innovation without hampering clinical care.
The Impact of FDA’s Rule
AMP believes the FDA LDT rule will drastically alter how lab services are regulated, significantly disrupting access to localized, evidence-based patient care and will also stifle innovation.
“The FDA rule duplicates already existing CLIA requirements and requires many more resources and staff at the agency to regulate the hundreds of thousands of laboratory-testing procedures that are used for patient care,” Menser says. “This new workload would significantly hinder FDA’s current obligations.”
Menser further argued that the FDA’s rule could have long-lasting consequences on the pathology profession. Smaller laboratories, particularly those serving rural or disadvantaged communities, may be forced to close due to the financial burden of complying with the new mandates.
“Many laboratories and laboratory 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 timely diagnose fast-moving diseases and mitigate emerging public health threats,” she said.
She emphasizes that the best approach to ensuring the quality and accuracy of LDTs lies in modernizing the existing Clinical Laboratory Improvement Amendments (CLIA) regulations.
Further reading: ADLM Says FDA’s LDT Final Rule Will Impede Fight Against Drug Epidemic
Why CLIA is the Preferred Pathway
Menser says that AMP has long maintained that modernizing the current CLIA regulations promulgated by CMS is the most effective way to ensure the continued development of accurate and reliable LDT procedures for correct utilization, precise interpretation, and proper application of molecular test results.
“AMP’s legislative proposal to update CLIA builds on the existing oversight framework and provides enhancements where necessary to provide assurances of test quality,” Menser says.
Specifically, the legislation will enhance testing quality and transparency in the following ways, according to Menser:
- The legislation requires the Secretary of Health and Human Services to develop minimum levels of standards for analytical and clinical validity.
- Labs will need to provide summary information about their tests upon request via a standardized format established by the Secretary to provide inspectors with the opportunity to review information about a test’s analytical and clinical validity.
- The Secretary will develop standards and processes that ensure that laboratory inspectors are appropriately trained to inspect and evaluate laboratories and all examinations and procedures that would be within the inspector’s responsibilities.
- It expands the number of tests subject to standardized proficiency testing, and when a proficiency testing program does not exist, it requires that all other tests be evaluated via an alternative assessment approach on a quarterly basis.
- With input from the public and the Clinical Laboratory Improvement Advisory Committee, it will create requirements specific to laboratory-developed testing procedures with 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,” added Menser. “These organizations enlist experts to support their operations and accredit laboratories in certain specialties and subspecialties. AMP’s proposed legislation continues the successful role of third-party accreditation organizations, ensuring there are sufficient personnel to verify the quality of all clinical laboratory testing.”
AMP’s Vision for the Future
Looking ahead, AMP is deeply concerned about the potential long-term impacts of the FDA’s rule if it is not vacated. Menser warned that the rule could lead to significant job losses, reduced training opportunities, and further exacerbate the ongoing shortage of pathologists in the United States.
“It is imperative that this Court act to prevent the catastrophic consequences that FDA’s Final Rule will unleash,” she concluded.
