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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 Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review
The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review
Michigan Law Review
Two judicial decisions in the early 1950s construing the FTC's section 13 (a) power produced a conflict that has not been resolved either by later courts or by the amendments to section 13 enacted in 1973. The dispute basically concerns the depth of the courts' inquiry into whether an advertisement violates- section 12 and the applicability of traditional equitable concepts in the context of the statutory injunction procedure. This Note contends that the legislative history of pertinent provisions of the Act suggests an appropriate resolution of the conflict through a two-step approach that would relax the scrutiny ordinarily accorded petitions …