Back to: Introduction to FDA’s Office of Trade and Global Partnerships
🔔 Note: Stop playback at 34:33 to complete this lesson.
Presenter
Kristan Callahan
Senior Public Health Advisor
Office of Trade and Global Partnerships (OTGP)
Office of Global Policy and Strategy (OGPS)
Office of the Commissioner (OC)
US Food and Drug Administration (FDA)
Abstract
This presentation by Kristan Callahan details the FDA’s crucial role in global trade policy for medical products. The agency ensures that U.S. trade positions align with FDA policies and leverages trade agreements to advance public health priorities. A primary focus is addressing Technical Barriers to Trade (TBT), where FDA works to ensure that regulations concerning pharmaceutical products are not overly trade-restrictive while respecting countries’ rights to protect public health. The Office of Trade and Global Partnerships (OTGP) represents FDA in related discussions and negotiations, providing technical expertise. The FDA has actively shaped significant trade agreements such as the USMCA, which uniquely includes sector-specific chapters for medical devices and pharmaceuticals to promote regulatory harmonization. More recently, the FDA participates in the Indo-Pacific Economic Framework for Prosperity (IPEF), particularly its supply chain resilience efforts. Furthermore, the presentation emphasizes the promotion of transparency and Good Regulatory Practices (GRPs) among partners, which help prevent unnecessary trade barriers by ensuring clear communication, stakeholder input, and consideration of regulatory impacts. Finally, OTGP monitors trade enforcement actions that could affect FDA-regulated products.