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HR 1794119th CongressIn Committee

United States-Abraham Accords Cooperation and Security Act of 2025

Introduced: Mar 3, 2025
Standard Summary
Comprehensive overview in 1-2 paragraphs

This bill would create a new Abraham Accords Office within the U.S. Food and Drug Administration (FDA). The office, led by a director, would be located in an Abraham Accords country within two years and staffed with FDA personnel as needed. Its core mission is to strengthen international regulatory collaboration with countries that signed the Abraham Accords by providing technical assistance to improve regulatory oversight and by promoting convergence of regulatory requirements for products regulated by FDA (such as drugs, devices, foods, cosmetics, and manufacturing practices). It would facilitate information sharing about U.S. regulatory pathways and collect feedback on research, development, and manufacturing. A Congress-wide report would be due within three years to assess progress, interactions, technical assistance, and coordination, and to offer recommendations for improved coordination. The bill also includes a national security safeguard and defines an “Abraham Accords country” as one identified by the Department of State as having signed the Abraham Accords Declaration.

Key Points

  • 1Establishment of the Abraham Accords Office within the FDA, headed by a director, with location in an Abraham Accords country within two years.
  • 2Duties include: providing technical assistance to regulatory partners in Abraham Accords countries to strengthen regulatory oversight and converge regulatory requirements (including good manufacturing practices) for FDA-regulated products; facilitating interactions and sharing information about U.S. regulatory pathways; and gathering feedback on research, development, and manufacturing of regulated products.
  • 3Staffing and authority: FDA will assign necessary personnel to the office to carry out its functions.
  • 4Definitions and safeguards: “Abraham Accords country” means any country identified by the Department of State as having signed the Abraham Accords Declaration; section’s actions must not contradict national security recommendations.
  • 5Reporting to Congress: Within three years, the Secretary of Health and Human Services must submit a report evaluating progress toward regulatory conformance, counting parties assisted, summarizing technical assistance, and offering recommendations to improve FDA coordination with Abraham Accords countries.

Impact Areas

Primary group/area affected: FDA, U.S. manufacturers and regulatory partners in Abraham Accords countries, and the regulatory ecosystems of those countries; potential expansion of U.S. regulatory influence and technical standards abroad.Secondary group/area affected: Department of State and U.S. national security apparatus (due to the location requirement and security considerations); international trade partners; patients and consumers via potentially faster or more harmonized regulatory pathways for medical products.Additional impacts: Potential changes in global regulatory collaboration, manufacturing practices alignment, and information sharing regarding U.S. regulatory pathways; considerations for funding and resource allocation within FDA to staff and operate the new office.
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