Trio of Lawmakers Introduces Resolution to Repeal FDA Final Rule on LDTs

WASHINGTON, DC — May 17, 2024 — U.S. Congressmen Brad Finstad (MN-01) and Dan Crenshaw (TX-02) 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). U.S. Senator Rand Paul (R-KY) introduced the resolution in the U.S. Senate. The final rule, published May 6, seeks to impose burdensome regulations on the creation and implementation of laboratory-developed tests (LDTs), limiting patients’ access to critical diagnostic testing.

Oftentimes, LDTs are the only or most reliable option available within the US healthcare system that provide timely results to patients with rare diseases and conditions. 

Specifically, implementation of the FDA’s rule would

• impose regulatory burdens that hinder the development and deployment of new and improved lab-developed tests;
• increase regulatory requirements that will lead to delays in patients’ access to critical diagnostic tests;
• potentially hinder collaborative efforts in clinical care that rely on the flexibility provided by LDTs; and,
• negatively impact small and medium-sized laboratories, which will face economic challenges with complying with the rule as written.

“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,” said 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.” 

“This rule is the biggest unilateral expansion of FDA regulation in recent years. Unelected bureaucrats are saying they know better than the diagnostic developers and clinicians that make Houston a capitol for medical innovation,” said Rep. Crenshaw. “This is a clear case of unreasonable overregulation that will cost billions of dollars and put lives at risk by stifling medical innovation. I’m proud to cosponsor this legislation to revoke the rule so that Congress prevents executive overreach and reasserts its role as the first branch of government.”  

“Unnecessary regulations on lab-developed tests threaten to delay critical diagnostics and undermine healthcare innovation,” said Dr. Paul. “This CRA is a step toward preserving the innovation and flexibility needed to address emerging medical challenges and safeguard patient health.”

Background

In March 2024, Congressman Finstad sent a letter to the Chairwoman and Ranking Member of the House Committee on Energy and Commerce requesting an investigation into the impact that the FDA’s proposed LDT rule would have on the industry, as well as on small- and medium-sized laboratories.

Following the letter, the House Committee on Energy and Commerce conducted a hearing titled “Evaluating Approaches with Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule" during which Committee members heard testimony from members of the medical community about the harmful impact of the FDA’s proposed rule on the access to reliable tests for laboratories and patients.

- This press release was edited for clarity and style from the original, which was published on the Brad Finstad website