A Food and Drug Administration proposal to regulate laboratory-developed tests could upend a clinical sector that provides thousands of tests to healthcare providers every day, raising costs and potentially limiting patient access, detractors say.
But advocates of new regulation say some patients have been harmed by poor oversight of the tests. Some women who were tested for ovarian cancer with a specific laboratory-developed blood test, for example, chose to have their ovaries removed as a result of inaccurate test results, according to Laura Koontz, director of policy for the Ovarian Cancer National Alliance.
Both sides got their say Thursday and Friday during a two-day workshop featuring dozens of speakers representing laboratories, healthcare providers and patients who raised questions about the impact of the proposed regulation.
The medical device industry supports the proposed regulation. But other groups, such as the American Hospital Association and the American Medical Association, say FDA regulation of the tests will raise costs and potentially hinder patient access.
Another opponent, the American Clinical Laboratory Association, argues that the agency doesn't have the statutory authority to issue the proposed regulation.
“The FDA's effort to expand its jurisdiction and treat labs as manufacturers will interfere with the practice of medicine, disrupting the ability of doctors to obtain tests they need to provide the best care to patients,” Alan Mertz, the ACLA's president, said in a statement.
FDA regulation of lab tests won't guarantee better quality and may also limit access to community healthcare, Dr. Curtis Hanson, a hematopathologist at the Mayo Clinic in Rochester, Minn, said Friday at the workshop. The Mayo Clinic uses about 1,600 laboratory-developed tests. “Let's be sure we know what problem we're fixing,” he said.
Despite such contentions, regulation advocates came back to the issue of quality.
“What we do know is that many women were given dangerous and inaccurate results—with real consequences,” Koontz said in her testimony. “Ultimately, OvaSure (the test) was removed from the market—but not before countless women were put at risk.”
The FDA regulates diagnostic tests developed by laboratory manufacturers. Last year, it developed a risk-based framework to regulate laboratory-developed tests. Those tests are regulated by the CMS as the result of a law passed in the 1980s over concerns about the quality of pap smears.
“Faulty tests can lead to misdiagnosis or failure to diagnose, resulting in patients receiving unnecessary treatment, delays in treatment, or no treatment when treatment is needed,” Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in prepared remarks Thursday.
Laboratory-developed tests are widely used and include routine testing, including pap smears, for sexually transmitted diseases and more complex tests used to identify genetic variations that have high risks of certain cancers.
The discussion at the workshop highlighted the complexity of the tests and the extent of their prevalence in medicine. “How do you harmonize the FDA's new proposed directive with the existing safety framework that the clinical community has built over the past 40 years?” said Lakshman Ramamurthy, director of FDA and regulatory policy at Avalere Health.
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