ABSTRACT

Regulatory law is very different from law that originates with judicial decisions. The basis for regulation is legislation; statutes passed by Congress and state legislatures and often spelled out by administrative agencies that are creatures of the legislation. One is that courts often determine whether regulations passed by agencies are proper use of the language of statutes. A law of this kind with far-reaching effect is the Occupational Safety and Health Act, under which the Occupational Safety and Health Administration and the Secretary of Labor may take action against employers who violate regulations. The Supreme Court upheld this regulation, affirming a judgment by a court of appeals that reversed a decision by the federal district court. There are a number of issues that cut across the many controversies that arise concerning safety regulation. Part of the background of government regulation of medical products is the vastness of the research enterprise and the competition within it.