New Drug Research, the Extraterritorial Application of FDA Regulations, and the Need for International Cooperation

Article excerpt

ABSTRACT

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

I. INTRODUCTION

In 1996, Pfizer, a large U.S. drug company, developed a new antibiotic called Trovan. …