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2016 may be year of action on laboratory-developed tests
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2016 may be year of action on laboratory-developed tests
During a session at the Association for Molecular Pathology’s annual meeting in November, Rep. Michael Burgess, MD (R-Tex.), said he expects the Food and Drug Administration to issue its long-awaited final guidance on laboratory-developed tests during the first quarter of 2016.
FDA officials, meanwhile, have been more circumspect in their public statements. In a recent meeting of the CDC’s Clinical Laboratory Improvement Advisory Committee, Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, described the agency’s potential action on LDTs in 2016 using the conditional “if.”
When the FDA released its proposed regulatory framework for LDTs in July 2014, it sparked criticism from virtually every side. What perhaps few expected was that 2015 would slip by without agency action on the matter.
The FDA’s November 2015 release of a report designed to make the case for stricter oversight of LDTs garnered coverage in The New York Times and elsewhere, and to some eyes it presaged a definitive move in the new year, or at least aimed to offer Congress some support for legislative action on the matter. It was released the day before a hearing on LDTs held by the House Energy and Commerce Committee’s health subcommittee.
“We examined events involving 20 LDTs that illustrate, in the absence of compliance with FDA requirements, that these products may have caused or have caused actual harm to patients,” said the FDA report’s executive summary.
The AMP has issued a report in response (http://j.mp/amp20cases), arguing that the FDA often mischaracterizes the nature of the tests, how they were used—or misused—by clinicians, and whether the problems detailed were ones that stricter FDA oversight could have prevented. In an interview, AMP Professional Relations Committee chair Roger Klein, MD, JD, says the agency’s case studies too often rely on news media reports rather than peer-reviewed literature. In one specific case, he says the FDA appears to have failed to do “due diligence” by not talking with the laboratory and institution at issue to learn their depiction of the facts underlying the news report on which the agency relied.
The AMP says the Centers for Medicare and Medicaid Services should use third-party reviewers to scrutinize the clinical validity of high- and moderate-risk LDTs, and that FDA oversight of the tests would do more harm than good.
The FDA’s regulatory plan for LDTs “is a major step and has sweeping implications that the agency is only beginning to understand,” says Dr. Klein, medical director of molecular oncology at Cleveland Clinic.
“If they were to go ahead and finalize that document, it would seemingly shut down next-generation sequencing for oncology at most major academic medical centers. The reason it would is because FDA’s claimed highest-risk procedures are those tests that are used to select targeted drug therapies. NGS tests are, in fact, used to guide drug therapy in oncology patients for tumors and drugs for which FDA-approved tests are available.” As currently written, he says, the FDA’s draft guidance would appear to require laboratories to obtain premarket approval for such tests, which generally requires clinical trials. Such a course would prove cost-prohibitive for academic hospital laboratories.
Dr. Klein says he remains skeptical that the FDA will finalize its 2014 proposal, at least in anything like the form in which it was presented initially. “It’s a big trigger to pull,” he says. “It’s like the nuclear option.”
The American Clinical Laboratory Association has already said it will take legal action to stop the FDA if the agency acts to finalize its LDT proposal. ACLA says the agency must pursue its proposal using the federal rule-making process, rather than through guidance.
Dr. Klein says participation in litigation is something the AMP would be willing to consider. Apart from the FDA’s “highly questionable” jurisdiction to regulate LDTs, he says, the FDA’s proposal requires issuance of new regulations as opposed to a nonbinding guidance document because it is “more than a mere policy change…it involves implementation of an entirely new regulatory scheme.” —Kevin B. O’Reilly