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Sept. 20 — Clinical laboratories could face significant costs if the FDA moves forward with plans for lab-developed tests, the chairman of a Senate committee said Sept. 20.
Vanderbilt University’s lab in Nashville, Tenn., for example, could spend $30 million to $75 million to get Food and Drug Administration approval for a single high-risk laboratory-developed test (LDT) under the agency’s plan to regulate the tests, Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.) said during a hearing.
The FDA’s approval process for high-risk medical devices required manufacturers to spend roughly $75 million to get those products on the market as of 2010, Alexander said as a point of reference.
The cost figures quoted by Alexander are likely too high, David S. Klimstra, a pathologist and the chairman of the Department of Pathology at the Memorial Sloan Kettering Cancer Center in New York, said at the hearing. Nonetheless, he testified, if the agency moves forward with its LDT plans, Memorial Sloan Kettering would need to stop making LDTs because of the monetary and time costs associated with getting FDA approval.
A potential shift in which agency regulates LDTs has been a key issue for the lab industry for nearly two years. LDTs are tests that are designed, manufactured and used in a single laboratory. The Centers for Medicare & Medicaid Services currently regulates these tests, but the FDA issued two controversial draft guidance documents in 2014 outlining its planned oversight of LDTs (190 HCDR, 10/1/14).
Committee Democrats generally voiced support for the FDA’s plans.
The current LDT regulatory system doesn’t provide doctors and patients assurance that the test results are valid, the committee's ranking Democrat, Sen. Patty Murray, said.
Jeffrey Allen, the president and chief executive officer of the Washington-based nonprofit group Friends of Cancer Research, agreed with Murray's stance.
Given the role that medical tests play in optimizing and determining patient care, it is imperative that these tests’ accuracy be well characterized before placing important treatment decisions on the results that they provide, Allen said in written testimony.
Furthermore, the ramifications of uncertainty or inaccuracy can be quite significant, Allen said.
“An inaccurate test could result in a patient not receiving the most appropriate treatment or expose them to an unnecessary or potentially harmful treatment,” he said.
In fact, a recent report from the National Academies concluded that diagnostic errors, including some from molecular tests, account for 6 to 17 percent of adverse events in hospitals and played a role in 10 percent of patient deaths, Allen told lawmakers.
Various industry groups used the hearing to reiterate their stance on the issue.
The American Clinical Laboratory Association (ACLA), which represents the lab industry and has been staunchly against the FDA's plans for LDTs, outlined 10 key principles to guide any reforms to oversight of the tests, according to a letter the group sent the committee's leaders.
In its letter, the group restated that LDTs aren't medical devices and shouldn't be regulated by the FDA as such. In addition, the federal government should implement any new framework for LDTs through notice and comment rulemaking, not guidance documents, the ACLA said.
However, AdvaMedDx, an industry group representing device makers that develop diagnostic kits that are already subject to FDA oversight, urged the agency to continue with the plans for regulating LDTs.
The FDA's “oversight is essential to ensuring that all diagnostic tests—including LDTs—are subject to premarket review, required demonstration of clinical validity, systematic adverse event reporting and other critical regulatory safeguards,” Andrew Fish, executive director of AdvaMedDx, said in a Sept. 20 statement.
While AdvaMedDx supports congressional efforts to improve oversight of LDTs, there shouldn't be legislation to prevent the FDA from exercising its authority over the tests, Fish said.
“Delay in finalizing a regulatory oversight framework for LDTs does not benefit patient safety or innovation,” he said.
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