IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed FDA LDT guidance. Among the interesting insights are that FDA officials will not be surprised if some labs file a lawsuit challenging the federal agency’s legal authority to regulate LDTs. To this point, the FDA official discusses the history of FDA oversight of medical devices and medical laboratory tests and why the agency believes that recent developments in how labs develop and offer LDTs nationally warrant its action to regulate and oversee these tests under current federal laws.
Forty years ago, pathologists in hospital and academic labs worked closely with treating physicians to produce laboratory-developed tests for discrete clinical cases. Seeing that, the FDA decided not to regulate those tests, according to Alberto Gutierrez, PhD, Director of the FDA’s Office of In Vitro Diagnostics and Radiological Health.
Over time, however, use of LDTs became a serious concern when labs developing LDTs were no longer involved with their use for individual clinical cases. These labs marketed their LDTs nationwide and made claims about their validity that were unsupported by evidence, the Gutierrez says.
Gutierrez was one of four speakers who participated in a recent webinar sponsored by the Harvard T.H. Chan School of Public Health and STAT News.
Separately from this webinar appearance, the FDA gave lab executives and pathologists an idea of the evidence that it will put forward to demonstrate that LDTs can harm patients. On November 16, 2015, prior to a Congressional hearing on LDTs, the FDA issued a 39-page FDA report, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies.”
And in his presentation, Gutierrez predicted that the FDA guidance will proceed despite pushback from clinical laboratories. He invited clinical labs to work with the FDA to improve its review processes.
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