Pharmaceutical Drug Testing in the Former Soviet Union: Contract Research Organizations as Broker-Dealers in an Emerging Testing Ground for America's Big Pharma

Abstract

Developing countries are a fertile testing ground for the research and development of new drug products. Recently, Western pharmaceutical companies expanded their overseas drug testing from India and Africa to the former Soviet Union, where doctors in need of reliable income conduct clinical trials on subjects seeking access to medical care. Although U.S. government agencies monitor clinical drug trials sponsored by American pharmaceutical companies, the scope of governmental authority is effectively limited to the companies’ domestic activities. In October 2008, restrictions on the FDA’s supervisory powers were further reinforced by the agency’s substitution of the ethical research principles found in the Declaration of Helsinki with other, less subject-oriented standards. This revision threatens the health and safety of clinical trial participants in the former Soviet Union, where large populations of the ailing poor prevent local governments from imposing substantial restrictions on Western pharmaceuticals manufacturers. This Comment criticizes the practice of exploiting underprivileged populations for Western scientific progress, and argues that Congress must immediately respond to the FDA’s October 2008 resolution by acknowledging the Nuremberg Code as customary international law by which American pharmaceutical companies must abide.