The architecture of government regulation of medical products; Commentaries

An article accepts reformers' hypothesis that legal structure - the content of the standards applicable to new products and the procedures for applying them - has a critical bearing on the rate of new product introduction, and on the cost of those products that are introduced. The article recounts the evolution of these standards and procedures and, in the process, seeks to identify the forces that have influenced this evolution. The article: 1. describes the development of the modern regime for regulating drugs, 2. depicts the more recent emergence of the regime for medical devices, and 3. concludes by analyzing the major proposals for statutory reform currently being debated in Congress. Commentaries by Marmor and Temple are included.