To explore these concepts, this paper focuses on the Japanese motivation for taking control in the pharmaceutical industry and efforts that the US can take to ensure its role as a leader in the pharmaceutical industry. First, the paper discusses how Japan is poised to invade the US pharmaceutical market, reasons for Japanese entry into the market, the Japanese focus on research, recent examples of Japanese expansion and how US policy may affect Japanese expansion into the pharmaceutical market. The next section describes the need for the FDA to protect consumer interests in the US since market forces and / or the legal system cannot protect consumers against unsafe or ineffective drugs. The third section discusses both the fallacy of a proposal to deregulate the FDA and the effects of the proposed deregulation on the Japanese penetration of the pharmaceutical industry. Additionally, the need for FDA protection in a global market is stressed. The fourth section deals with the critical role of research to maintain US leadership in the pharmaceutical market. Finally, the fifth section discusses Japanese approaches that the US may adopt to help maintain its leadership position in the world pharmaceutical market.
Rachel F. Ochs, Pharmaceuticals: The Battle for Control in the 21st Century, 10 J.L. & Health 297 (1995-1996)