Regulating the Export of Unapproved Drugs

Abstract

Prior to 1986, it was not possible under the Federal Food Drug and Cosmetics Act to export drugs which did not have FDA approval. The law was changed by the Drug Export Amendments Act of 1986 after nearly a decade of debate. Those who favored liberalizing the drug export law argued that American companies were at a competitive disadvantage in foreign markets because of the prohibitions, and the pharmaceutical industry suffered as a result. They argued that the national sovereignty of those countries that decided that unapproved drugs were appropriate for use by their citizens should be respected, and that it would be excessively paternalistic to deny these countries the products they desired. Those who opposed lifting the ban on exporting unapproved drugs argued that economic concerns were not sufficient to overcome the ethical difficulty in creating a double standard which allowed drugs that had not been determined safe and effective for use by U.S. citizens to be used by the citizens of foreign nations.