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At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of laboratory developed tests (LDTs).

Under the Food and Drug Administration Safety and Innovation Act of 2012, the FDA is required to notify Congress sixty (60) days before the publication of draft guidance on regulation of LDTs. As a result of this requirement, the FDA announced in July of this year that it would begin regulating LDTs, saying that tests used to make important treatment decisions need to be subject to FDA oversight before they go into use, and that the FDA would be releasing two guidance documents regarding oversight of LDTs ─ “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” ─ for public comment in sixty (60) days.  During last week’s hearing, Republican congressional representatives accused the FDA of sidestepping the rulemaking process by deciding to issue guidance rather than a formal rule.

The FDA has the authority to regulate medical devices and, as such, has long regulated tests marketed and sold to healthcare facilities, laboratories, physician offices, and the general public.  However, those tests developed and performed by a laboratory, with all samples being sent to that laboratory, have typically not been subject to FDA regulation. The FDA claimed that, while it has always had the legal authority to regulate LDTs, it had been exercising “enforcement discretion” by choosing not to do so until now.

Not surprisingly, this decision to begin regulating LDTs is being opposed by many laboratories and pathologists, who believe that such FDA regulation is not only unnecessary, but would also stifle innovation by increasing the time and expenses involved in test development.  Critics also have argued that the FDA does not have proper jurisdiction over LDTs, as the testing is not a medical device but rather a medical service.  Additionally, critics contend that LDTs already are regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Laboratories engaged in LDTs should pay close attention to these developments as FDA regulation has the potential to significantly affect LDT product timelines and budgets.  For those parties interested in participating in the public comment period, the FDA will publish a notice in the Federal Register when the draft guidances are released. The agency also has stated that it intends to hold a public meeting during the comment period to collect additional input.

FDA Regulation of Laboratory Developed Tests on the Horizon