Joseph R. Pitts (R-PA) Chair of the House Energy and Commerce Subcommittee on Health http://energycommerce.house.gov/subcommittees/health recently held a hearing recently to address FDA’s issuing of draft guidance documents that would fundamentally alter the regulatory landscape for the review and oversight of LDTs.This draft document has raised legitimate concerns about whether FDA can or should use guidance to promulgate a new regulatory approach.
At the hearing “Examining the Regulation of Laboratory Developed Tests” (LDT), Chairman Pitts said, “Any framework adopted must not only prioritize patient safety but it must also encourage robust investment and allow for continued innovation.
In order for this to happen, a company or venture capitalist investing in the development, testing, and FDA review of a diagnostic product must have the certainty that labs will not copy it and promote their alternatives the next day.”
Jeffrey Shuren, MD, JD, Director for FDA’s Center for Devices and Radiological Health www.fda.gov/medicaldevices /default.htm appeared before the Committee to discuss several factors related to the issue:
- LDTs offered today are often very different from those of the 1970s and have increased in both complexity and availability. Both patients and providers have to make decisions based on today’s LDTs
- Without appropriate FDA safeguards, neither patients nor providers can be assured that many of these tests are safe and effective
- FDA is aware of faulty or unproven LDTs including problems with several high-risk LDTs
- Several agencies and the Institute of Medicine have recommended additional oversight of LDTs and identified FDA as the agency to provide the oversight as the agency already has the structure to oversee in-vitro diagnostics and LDTs are a subset of IVDs.
- Since adverse events are not systematically reported or collected for LDTs, FDA does however have the mechanism for reporting and tracking adverse events
- FDA intends to continue to exercise enforcement discretion for many LDTs including those that are low risk for rare diseases and for unmet medical needs.
Alan Mertz, President of the American Clinical Laboratory Association www.acla.com presented his viewpoint on FDA’s regulation of LDTs. He said “Subjecting LDTs to FDA regulation would eliminate the very characteristics which make LDTs and the regulatory framework that governs them so vital, and flexible in their ability to respond to unmet needs.”
In addition, “FDA regulation of LDTs as medical devices would dramatically slow not only the initial premarket approval of new tests but also improvements to existing tests thereby delaying access to new and improved diagnostic testing services for patients and clinicians.”
He added, “If stakeholders have concerns about possible gaps in the clinical validation of LDTs, the most logical and appropriate solution would be to amend Clinical Laboratory Improvement Amendments (CLIA) and/or its regulations.”
He finalized his testimony by saying, “It would be overly burdensome to superimpose a new bureaucratic regime on the laboratory industry which is already highly regulated under CLIA. It would be like trying to fit a square peg into a round hole to impose an additional layer of regulation based on a statue designed for products rather than laboratory testing procedures.”