Rep. Roy, Sen. Cruz Re-Introduce Legislation to Cut Bureaucratic Red Tape for Lifesaving Medicine
February 26, 2025
WASHINGTON — Rep. Chip Roy (TX-21) and Sen. Ted Cruz (R-TX) re-introduced H.R. 2159 the "Reciprocity Ensures Streamlined Use of Lifesaving Treatments" (RESULT) Act today. This bill will expedite the Food and Drug Administration's approval process for potentially lifesaving medicines.
Congressman Roy said: "Waiting for a pencil-pusher in Washington to green-light medications that are already approved in other trusted countries is the epitome of the bureaucratic nightmare that has plagued our healthcare system. This bill would cut through a wall of red tape that separates Americans from getting the care that they need, which means prioritizing their healthcare freedom.”
Senator Cruz said: “Washington bureaucracy and regulations far too often interfere with the healthcare decisions of patients and their doctors. The RESULT Act will facilitate access to life-saving drugs, devices, and medical treatments that are already proven safe and effective in other trusted countries, empowering patients to access the medications they need to improve their health. I’m proud to be advancing it, and I call upon my colleagues to expeditiously take it up and pass it.”
The RESULT Act will:
Congressman Roy said: "Waiting for a pencil-pusher in Washington to green-light medications that are already approved in other trusted countries is the epitome of the bureaucratic nightmare that has plagued our healthcare system. This bill would cut through a wall of red tape that separates Americans from getting the care that they need, which means prioritizing their healthcare freedom.”
Senator Cruz said: “Washington bureaucracy and regulations far too often interfere with the healthcare decisions of patients and their doctors. The RESULT Act will facilitate access to life-saving drugs, devices, and medical treatments that are already proven safe and effective in other trusted countries, empowering patients to access the medications they need to improve their health. I’m proud to be advancing it, and I call upon my colleagues to expeditiously take it up and pass it.”
The RESULT Act will:
- Amends the Food, Drug, and Cosmetic Act to allow for reciprocal approval of drugs, devices, and biologics from foreign sponsors in certain trusted, developed countries including the EU member countries, United Kingdom, Israel, Australia, Canada, and Japan.
- Provides the FDA with a 30-day window to approve or deny a sponsor's application for reciprocity.
- Instructs the Secretary of Health and Human Services (HHS) to approve a drug, device, or biologic if the FDA confirms the product is:
- Lawfully approved for sale in one of the listed countries;
- Not a banned device by current FDA standards;
- There is a public health or unmet medical need for the product.
- Grants Congress the authority to disapprove a denied application and override an FDA decision with a majority vote via a joint resolution.
Read the full legislation here.