In recent years, U.S. pharmaceutical companies have expanded their new drug trials beyond the borders of the United States. While the companies have a variety of reasons for making this move, among them may be a desire to avoid Food and Drug Administration (FDA) regulation and monitoring. Lack of adequate supervision of drug trials conducted in the developing world endangers both the subjects of the tests and the consumers in the United States. It is unclear whether the FDA can execute regulatory and supervisory authority abroad. The FDA statute does not clearly authorize the agency to regulate extraterritorially. Applying the presumption against extraterritoriality, the FDA should not, therefore, be allowed to regulate drug testing abroad. Exceptions to the presumption might, however, be applicable. Regardless of whether U.S. courts allow the FDA to bring actions against companies for violations abroad, international cooperation is needed to control drug testing.
New Drug Research, The Extraterritorial Application of FDA Regulations, and the Need for International Cooperation,
36 Vanderbilt Law Review
Available at: https://scholarship.law.vanderbilt.edu/vjtl/vol36/iss1/10