WASHINGTON – U.S. Senator Tommy Tuberville (R-AL) joined U.S. Senator Rand Paul (R-KY) in a resolution of disapproval under the Congressional Review Act (CRA) to oppose the Medical Devices: Laboratory Developed Tests (LDTs) rule that was recently finalized by the Food and Drug Administration (FDA). The final rule, published May 6th, seeks to impose burdensome regulations on the creation and implementation of LDTs, limiting patients’ access to critical diagnostic testing. Additionally, 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.
“Yet again, the Biden administration is exercising executive overreach,” said Senator Tuberville. “Excessive regulations on LDTs pose a risk of delaying vital diagnostics patients critically need. Alabama hospitals use these tests every day, and I will fight to ensure Alabamians get the best care possible in our medical centers.”
Senator Tuberville was joined by Senators Marsha Blackburn (R-TN), Ted Budd (R-NC), Katie Britt (R-AL), Bill Cassidy (R-LA), and Eric Schmitt (R-MO) in introducing the legislation.
U.S. Representative Brad Finstad (R-MN-01) introduced the companion resolution in the U.S. House of Representatives.
View the full text of the resolution here.
BACKGROUND:
Lab tests are often the only or most reliable option available within the U.S. healthcare system that provide timely results to patients with rare diseases and conditions. Specifically, implementation of FDA’s rule would:
- Hinder the development and deployment of new and improved lab-developed tests.
- Delay or deprive patient access to tests that diagnose or indicate whether a patient is genetically predisposed to cancer, heart disease, and other conditions.
- Impede collaborative efforts in clinical care that rely on the flexibility provided by lab tests; and,
- Limit the test offerings made available to patients because the economic burden imposed by the rule may force small and medium-sized laboratories to close.
Senator Tommy Tuberville represents Alabama in the United States Senate and is a member of the Senate Armed Services, Agriculture, Veterans’ Affairs, and HELP Committees.
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