Hill Country Chronicle

WASHINGTON, DC — On May 18, Rep. Chip Roy (R-TX-21) reintroduced the "Reciprocity Ensures Streamlined Use of Lifesaving Treatments" (RESULT) Act to expedite the Food and Drug Administration's approval process for potentially lifesaving medicines.

Rep. Roy said, “The American people should not have to wait years and years for bureaucrats at the FDA to sign off on medicines that are already approved in other trusted countries.

This bill would cut through another wall of red tape that separates Americans from care, which means taking power away from the pencil pushing gatekeepers and putting it back where it belongs — the doctor-patient relationship.”

Rep. Roy first introduced the RESULT Act in March 2020. This bill would amend the Food, Drug and Cosmetic Act to allow for reciprocal approval of drugs approved in other trusted nations. Additionally, the legislation would require the FDA to quickly review drug, device, and biologic applications from companies that have products approved and sold in developed and reliable countries.

Senators Ted Cruz (R-TX) and Mike Lee (R-UT) introduced companion legislation in the Senate.

BILL BACKGROUND:

• 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 piece of legislation here.

Original source can be found here.