Regulation

Purpose and Functions

The primary purpose of government regulation is to develop and enforce the detailed rules that effectuate statutes. When the U.S. Congress or a state legislature enacts a law, it cannot account for all the technical aspects of implementation, as legislators do not have the time or the expertise to do so. Statutes typically set overall policy guidance in a field and direct an agency to bring it to fruition. For example, the U.S. Congress mandated that the Food and Drug Administration (FDA) ensure the safety and efficacy of all new drugs and devices but left it to the agency to determine the manner in which clinical testing will be conducted. The legislature in every state has required that physicians be licensed by a medical board to practice and directed these boards to set the actual qualifications for licensure.

In a private context, regulation implements policy decisions of professional and industry organizations. For example, the hospital members of the Joint Commission seek to have all institutions function at a uniform level of quality. Committees within the organization devise the actual standards that must be met to exhibit quality and the procedures for enforcing them. Similarly, the physician members of medical specialty societies seek to ensure that practitioners display minimum levels of skill and competence. Committees of these bodies develop examinations and practice guidelines to assess these attributes.

Government regulators serve four main functions. First, they promulgate rules and standards that fill in the details of legislation, as when the FDA specifies the procedures for testing a new drug. This activity is known as rulemaking. Second, they conduct adjudications that enforce those rules and that grant rights and privileges under them, such as the right to practice medicine. Third, they administer government functions, such as hospital operations in the Veterans Administration (VA). Fourth, they disperse funding for targeting purposes-for example, support for biomedical research by the National Institutes of Health (NIH).

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