Subcommittee Chair Guthrie Opening Remarks on Regulation of Diagnostic Tests (3.21.24)

chair recognize I recognize myself for 5 minutes for an opening statement thank to thanks to our Witnesses for uh joining us today we're here to we are thanks to our witness for joining us today we're here to examine the history of diagnostic test regulation previous legislative proposed is to update this regulatory framework and the Biden administration's current proposed to regulate laboratory developed tests or ldts as medical devices the current oversight structure for a do diagnostic tests including laboratory develop tests is split between us F US Food and Drug Administration and the centers for Medicare Medicaid services in 1976 Congress gave the FDA the explicit authority to regulate the medical device industry at the time of enactment the FDA adopted an enforcement discretion policy as a matter of practice over ldts over time it became clear to policy makers industry stakeholders and patient groups that a separate regulatory approach was needed for ldt to protect the health and well-being of patients as well as create more standardization across the Health Care system which led to the passage of the 1988 Clinical Laboratory Improvement amendments in establishing the Clea or Clea in establishing the Clea program Congress intended to ensure the accuracy and reliability of all Laboratory Testing in the wake of reports of inaccurate clinical tests ldts are viewed as an important as important tools for medical uses from helping to treat cancer to Common Public Health purposes like help helping law enforcement and healthc Care Professionals determine which drugs are being trafficked and sold in their communities lab develop tests also must go through certification requirements under Clea in addition to state public health regulators and independent accrediting agency such as Dr Carter's organization the College of American Pathologists or cap despite many known benefits of lab develop tests the FDA has repeatedly attempted for almost two decade to completely reform how these tests are regulated in order to give the agency sole discretion and policing power over all diagnostic tests regardless of whether they are developed and run by the same laboratory or developed to be and to be sold and used elsewhere under proposed FDA rule announced in September 2023 the vast majority of ldts will be regulated as medical devices this means they would need to go through fda's existing medical device framework such as the 510k a clearance process or pre-market approval Labs will not be able to make simple modifications to existing diagnostic tests or even novel tests undermining the flexibility provided through the ldts even more problematic the proposed rule doesn't include a grandfathering clause that would allow for the continued use of Clea certified ldts without disruption commissioner caleff cited concerns relating to the performance of current ldts that could potentially lead to un un necessary care or delaying necessary care is a primary reason why the FDA needs this additional policing power he further states that over 70% of medical conditions rely on ldts and other senior FDA officials have stated the current approach to disincentives Innovation the current approach disincentivize in Innovation as conventional kit manufacturers do adhere to the medical device framework to be clear I agree with commissioner Caleb that our regulatory approach always needs to ensure we're protecting patients while facilitating Innovation however I remain concerned whether fda's proposal will protect patients in the most effective way achieve lower costs or Foster greater Innovation however we cannot Overlook the unintended consequences this prop rules proposed rule could cause namely it could lead to Greater consolidation among testing providers reducing access to high quality care for patients living with life-threatening diseases especially in the cell gene therapy space set our health care System back on our mission to move closer to toward closer toward personalized medicine and have harmful effects on disadvantage and Rural populations also question whether the FDA is going to execute the authorities that it seeks given its experience with an influx of covid applications to put all of this into greater context the American Hospital association's comment letter one of nearly 7,000 the FDA received on this proposed rule mentions one of its sister systems has 1,600 lab develop tests assuming they were pursuing a 510k clearance the 2023 user fee rates PID by manufacturers through the FDA for a 510k this can mean the system ends up paying upwards of more than 31 million to comply with the fda's rule as diagnostic testing becomes more complex I believe it is essential that Congress worked with the public health community physicians and patient groups to address any current challenges with providing patients with the highest quality Diagnostics without stifling Innovation I cannot support the fda's proposed Rule and it hope it is withdrawn but do look forward to continue the discussion on possible legislative proposals to address outstanding challenges with ldts thank you and I yield back the chair