By Diagnostics World Staff
November 21, 2016 | The U.S. Food and Drug Administration has put its plan on hold to regulate laboratory-developed tests, waiting instead for input from the new Presidential administration and the new Congress.
An FDA spokesman told the Wall Street Journal that patients and health-care providers “need accurate, reliable and clinically valid tests” and that it would “continue to work with stakeholders, our new administration and Congress to get our approach right.”
FDA announced it plans to regulate laboratory developed tests (LDTs) in the same way it does other diagnostics in 2014, though the Agency had been expressing interest in the space since 2006. The tests—of which there are thousands—have been regulated by the Centers for Medicare and Medicaid Services through CLIA lab certification. They are a type of in vitro diagnostic, which uses a sample taken from a patient, like blood, saliva, or a tissue biopsy, to diagnose a medical condition.
FDA’s foray into the space drew criticism from diagnostics companies, hospitals, and the Association of Molecular Pathologists. A group of academic lab directors wrote to the Office of Management and Budget in July 2014, all representatives of nonprofit hospital centers, all intimately involved in patient care.
The authors were strongly opposed to any FDA regulation of LDTs, asserting that CLIA certification already provides “extensive validation and continuous monitoring to ensure the performance, quality and reliability of diagnostic services.” The authors were especially concerned that some tests may become completely and permanently unavailable if LDTs become subject to premarket approval. “Some testing currently performed at laboratories as LDTs will never generate the financial returns to justify the costs of obtaining FDA clearance or approval,” they wrote. “Patients served by these tests would be left with no testing options.”
Last August, the Association of Molecular Pathologists released its own plan for how LDTs should be regulated. Roger Klein, Medical Director for Molecular Oncology at the Cleveland Clinic and Chair of the AMP’s Professional Relations Committee, outlined his plan for Diagnostics World. The Centers for Medicaid and Medicare would retain control of the process.
“CLIA has a very strong analytical framework, and if a test isn’t performing properly, CLIA is designed to remove it from use. That’s particularly important with respect to analytical performance, because the end user may not have the ability to evaluate that independently. Truthfully, clinical validity tends to be less of a problem,” Klein said.
Klein also said that FDA—“nor anybody else”—had put forth evidence that there is a “systematic problem with laboratory testing in the United States.” Perhaps FDA took the statement as a challenge.
Three months later, FDA released a collection of case studies outlining how LDTs “may have caused or have caused actual harm to patients.” FDA argued that with its own regulatory oversight, that harm could have been avoided.
AMP objected to the characterizations, releasing a case-by-case rebuttal, calling the FDA’s report “irresponsible”, and warning that it may, “cause unwarranted stress to patients, needlessly scare the American public, and lead patients to unduly question the quality of care,” they received.
It seems, for now anyway, that the objections have worked.
AMP released a statement today applauding FDA for its retreat from the issue. “AMP believes this decision is in the best interest of patients, healthcare providers, and the entire field of molecular pathology,” the statement reads.
“We are pleased that the FDA has decided not to finalize the guidance and we look forward to our continued discussions and professional collaborations to ultimately develop a streamlined approach that ensures high-quality patient care, enhances transparency, and preserves innovation,” said Mary Steele Williams, Executive Director, AMP, in the published statement. “Challenging the FDA’s initial draft guidance has been one of our top priorities. I’d like to thank all of our members for their countless hours spent developing and advocating for a CLIA-centric approach to LDP oversight and for their ongoing commitment to putting the patient first and preserving broad access to essential care.”