In response to domestic pharmaceutical producers' demands, Congress amended the Federal Food, Drug, and Cosmetic Act (FFDCA) on November 14, 1986. The advantages of foreign drug producers over United States drug producers prompted Congress to enact the Drug Export Amendments Act of 1986 (DEAA) which was designed to help United States drug producers compete effectively in the world market. The DEAA now puts domestic producers on more of an equal basis with the rest of the market by allowing them to export unapproved drugs.
The first section of this Note will examine the new amendment and outline its requirements. Then, it will explore the product liability laws of New Zealand, Great Britain, and West Germany. This discussion will present a broad overview of the divergent product liability regimes employed by various countries. These sections will also serve as a warning to the careless domestic producer. Finally, this Note will critique the present statute and the resulting opportunities for abuse that arise from the language of the statute.
James C. Grant,
The Impact of the Drug Export Amendments Act of 1986 on Foreign Tort Victims,
21 Vanderbilt Law Review
Available at: https://scholarship.law.vanderbilt.edu/vjtl/vol21/iss4/4