Summary: U.S. Senator Rand Paul introduced a resolution to repeal the FDA’s new rule on regulating laboratory-developed tests (LDTs), arguing that it oversteps authority and threatens medical innovation.
Takeaways:
- The FDA’s final rule on LDTs imposes new regulations on lab-developed tests, which are already regulated by the Centers for Medicare & Medicaid Services.
- Impact on Innovation and Access: The rule could hinder the development of new lab tests, limit patient access to diagnostic testing, and disrupt collaborative clinical care efforts.
- Senator Paul and Congressman Brad Finstad have introduced resolutions in the Senate and House, respectively, to repeal the rule and protect the flexibility and innovation in medical diagnostics.
U.S. Senator Rand Paul (R-KY) introduced a resolution under the Congressional Review Act (CRA) to repeal Medical Devices: Laboratory Developed Tests (LDTs), a rule that was recently finalized by the U.S. Food and Drug Administration (FDA).
The LDT Final Rule
The final rule, published May 6, 2024, seeks to impose regulations on the creation and implementation of laboratory-developed tests (LDTs).
“These tests are already regulated by the Centers for Medicare & Medicaid Services and Congress has never given the FDA the authority to regulate lab tests,” according to an official release from Paul’s website. “U.S. Congressman Brad Finstad (MN-01) introduced the resolution in the U.S. House of Representatives today.”
Potential Impact of the Final Rule
According to the news release, the implementation of FDA’s rule would hinder the development and deployment of new and improved lab-developed tests; limit the test offerings made available to patients; and impede collaborative efforts in clinical care that rely on the flexibility provided by lab tests.
“Unnecessary regulations on lab developed tests threaten to delay critical diagnostics and undermine healthcare innovation,” says Paul. “This CRA is a step towards preserving the innovation and flexibility needed to address emerging medical challenges and safeguard patient health.”
Further reading: Is the LDT Final Rule a Sword of Damocles?
“Minnesota’s First District is home to some of the most cutting-edge medical innovation in the world. With new technologies emerging every day, diagnostic testing is more advanced than ever before, largely thanks to laboratory developed tests,” says Rep. Finstad. “This harmful rule from FDA will stifle the development of new methods of testing, delay access to patient care, and impact many of the laboratories that we depend on in southern Minnesota for accurate, timely diagnostic testing. I am proud to introduce this resolution with Rep. Crenshaw to protect LDTs from overregulation and strengthen the relationship between medical innovation and patient care.”
Featured image: The Kentucky State Capitol building in Frankfort, Kentucky. Photo: Dreamstime
