New Drug Research, the Extraterritorial Application of FDA Regulations, and the Need for International Cooperation
DuBois, William, Vanderbilt Journal of Transnational Law
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.
TABLE OF CONTENTS I. INTRODUCTION II. THE GLOBALIZATION OF THE DRUG INDUSTRY AND THE FDA'S ATTEMPT TO KEEP PACE A. The Globalization of Pharmaceutical Research B. The FDA's Role in Drug Testing Abroad III. EXTRATERRITORIAL APPLICATION OF U.S. LAW AND THE PRESUMPTION AGAINST EXTRATERRITORIALTY A. Application of the Presumption Against Extraterritoriality in Environmental and Labor Law B. The "Effects Test" Exception to the Presumption Against Extraterritoriality in Antitrust and Securities Law C. Implied Congressional Intent and the Role of the Effects Test in the Extraterritorial Application of U.S. Criminal Law D. Exception for Crimes and Frauds Against the U.S. Government E. Does the Presumption Against Extraterritoriality Survive the Chevron Deference Approach? IV. THE FDA's POWER TO REGULATE U.S. DRUG RESEARCH ABROAD IS LIMITED A. The Food, Drug, and Cosmetic Act Does Not Exhibit a "Clearly Expressed" Congressional Intent for Extraterritorial Application B. Under Congress's Statutory Scheme the FDA Probably Has the Power to Accept Foreign Research Data C. If the FDA Can Accept Foreign Research Data, Then it Can Take Steps to Ensure the Efficacy of the Tests and the Reliability of the Data D. The FDA Probably Lacks the Authority to Regulate the Treatment of Human Subjects in Foreign Clinical Drug Trials V. INTERNATIONAL MECHANISMS PROTECTING HUMAN RESEARCH SUBJECTS OF MEDICAL TESTING ARE NEEDED A. The Difficulties of Regulating Transnational Corporations in the Developing World B. Unilaterally Using U.S. Law to Protect Human Research Subjects Would Violate the Doctrine of International Comity 1. U.S. Law Versus the Power of Developing Countries to Legislate for Themselves 2. The Anti-Democratic Force of Extraterritorial Application of U.S. Law 3. Potential Conflict of U.S. Law with Other Developed-Country Regulatory Practices C. The Role of International Law and the Rights of Human Test Subjects 1. The Status of Research on Humans Under International Law 2. The Lack of Status of Corporate Entities Under International Law D. Nations Must Work Together to Formulate Protections for Human Research Subjects VI. CONCLUSION
In 1996, Pfizer, a large U.S. drug company, developed a new antibiotic called Trovan. …