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Congressional Subcommittee Probes FDA on its Plan to Regulate LDTs

NEW YORK (GenomeWeb) – The House Energy and Commerce Committee's subcommittee on health yesterday held a hearing to discuss the US Food and Drug Administration's plan to bring lab-developed tests (LDTs) under its oversight.

The congressional hearing comes after the FDA provided notice at the end of July to the US Congress that it was planning to release draft guidance in 60 days outlining a risk-based regulatory framework for LDTs that will be phased in over the next decade. That framework proposes to regulate first the highest risk LDTs, such as tests with the same indication as FDA approved companion diagnostics, screening tests meant to be used in asymptomatic patients, and tests for infectious diseases.

Before putting forth this framework, the agency had exercised enforcement discretion over LDTs for 40 years, leaving oversight responsibilities to the Centers for Medicare & Medicaid Services under CLIA. However, as Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, told legislators today, CLIA regulations are ill suited to establish the safety and effectiveness of modern, high complexity diagnostics. CLIA looks at the analytical validity of tests (whether the test is gauging the marker it's supposed to), but it doesn't ensure clinical validity (whether the test can predict patients' clinical outcome).

However, members of the subcommittee raised questions about whether the agency had the legal authority to regulate LDTs. "How will this all work? How does the FDA intend to bring this framework upon the world and have it function without clear authority for Congress?" subcommittee Vice Chairman Michael Burgess (R-Tex.) said during the hearing.

The FDA has maintained that LDTs are in vitro diagnostics, and therefore fall under regulations laid out in the 1976 Medical Device Amendments. "There is authority under the statute. That authority is there and it's applied now. We haven't [previously] enforced it," Shuren said. "This discussion isn't new." The agency began talking of regulating LDTs in the 1990s and since then, many other agencies have urged FDA to bring LDTs under its oversight. The FDA has held meetings and tried to regulate certain types of LDTs through earlier guidance that it has since abandoned in favor of a more overarching policy.

All the while that the FDA has been saying it intends to regulate LDTs, the lab community has expressed strong opposition. Industry group American Clinical Laboratory Association has long held that if there are gaps in regulating LDTs, Congress should furnish CMS with the necessary resources to oversee these tests.

Alan Mertz, president of the industry group American Clinical Laboratory Association, told members of Congress that the FDA has taken on more than it can handle with its LDT regulatory plan. He estimated that there are 11,000 high-complexity labs performing LDTs, and "the potential workload for the FDA is staggering."

Legislators expressed concerns about how the agency intended to fund the additional reviews for LDTs. According to Shuren, while the agency doesn't plan to seek user fees from the industry in the next couple of fiscal years, eventually the agency will ask the lab industry to come to the negotiating table on this point.

Ultimately, the agency's decision to regulate LDTs is one it has taken out of concern forthe public's health. In July, when the agency initially gave Congress notice of its plans, FDA Commissioner Margaret Hamburg said that leaving LDTs to be overseen under less-stringent CLIA regulations has resulted in patients getting erroneous results or unnecessary testing.

Christopher Newton-Cheh, a cardiologist who testified before the subcommittee on behalf of the American Heart Association, said that just like the American public "would not support rolling back to a 19th century Wild West, where snake oil is indistinguishable from safe and effective therapies … they would not accept continuing unregulated LDTs in the 21st century."

The lab community has countered that this fear that a lack of FDA oversight of LDTs will harm the public is overblown. Congressman Henry Waxman (D-Calif.) pointed out that an HHS committee several years ago had found that "there had been few documented cases where patients experienced harm because of errors in a CLIA regulated genetic test."

To this Shuren provided several examples where LDTs have led to inaccurate results or unproven use. Furthermore, he pointed out that the extent of the harm patients may have experienced as a result of erroneous or unproven LDTs cannot be fully gauged because there is no adverse event reporting system in place under CLIA. FDA's LDT framework would enable adverse events tracking for LDTs. "The absence of evidence" that LDTs are a threat to public health "doesn't mean there is an absence of a problem," he said.

A more detailed version of this story was published Sept. 9 in PGx Reporter.