56 Pages Posted: 8 Feb 2006
Date Written: February 1, 2006
Administrative agencies frequently use guidance documents to set policy broadly and prospectively, in areas ranging from Education Department Title IX enforcement to FDA regulation of direct-to-consumer pharmaceutical advertising. In form, these guidances closely resemble those agencies issue in ordinary notice-and-comment rules, although guidances generally are developed with little participation and are often immune from judicial review. Nonetheless, guidances can evoke significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though they lack some important procedural safeguards, these documents can help agencies supervise low-level employees and supply valuable information to regulated entities regarding how an agency will implement a program. Thus far, however, this debate on administrative process has largely ignored the distinct and substantial interests of regulatory beneficiaries. These are people who expect to benefit from government regulation of others, such as pharmaceutical consumers, environmental users, and workers who seek safe workplaces. When agencies make policy informally, these regulatory beneficiaries suffer particular losses to their ability to participate in the agency's decision and to invoke judicial review. The article accordingly argues that when regulatory beneficiary interests are considered, the case for procedural reform of guidance documents is considerably stronger. The article then overviews some possible solutions.
Keywords: administrative law, administrative process, guidance documents, regulatory beneficiaries
JEL Classification: L51
Suggested Citation: Suggested Citation