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Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer
Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer
University of Michigan Journal of Law Reform
This article attempts to show that the OTC drug review has distinct advantages over traditional drug regulation. Part I outlines briefly the traditional case-by-case approach to drug licensing and describes FDA enforcement efforts prior to the OTC drug review. Part II sets forth the new rulemaking approach and considers the use of advisory panels. Part III examines several procedural questions associated with the review and concludes that the use of monographs as regulatory standards will afford the FDA an expeditious enforcement mechanism by resolving complex scientific issues at the administrative rather than the judicial level. Judicial review should be available, …
The Power Of The Fcc To Regulate Newspaper-Broadcast Cross-Ownership: The Need For Congressional Clarification, Michigan Law Review
The Power Of The Fcc To Regulate Newspaper-Broadcast Cross-Ownership: The Need For Congressional Clarification, Michigan Law Review
Michigan Law Review
The controversy surrounding the FCC's Second Report and . Order, its appeal, and the subsequent decision in NCCB raises basic questions concerning the statutory authority of the FCC to promulgate rules concerning newspaper-broadcast cross-ownership. This Note suggests that the FCC, notwithstanding judicial affirmation in NCCB of the Commission's authority to adopt such rules, might well be exercising more authority than Congress intended it to possess under the Communications Act of 1934. This Note therefore concludes that, irrespective of the merits of the Second Report and Order, Congress should reexamine and clarify the scope of the FCC's power in this regard.
Public Participation In The Adoption Of Interpretive Rules And Policy Statements, Michael Asimow
Public Participation In The Adoption Of Interpretive Rules And Policy Statements, Michael Asimow
Michigan Law Review
Section I of this article surveys the practices of a selected group of federal agencies in the adoption of interpretive rules and policy statements. It emphasizes the importance of these rules both to members of the public and to the administrative process. Section II analyzes the cases that have considered the AP A exemption of interpretive rules and policy statements from preadoption notice and comment procedures. These cases are in disarray for several reasons. For one thing, the bright lines traditionally assumed to distinguish interpretive rules and policy statements from legislative rules have become blurred and indistinct. Moreover, the courts …