Article by Margaret Gilhooley
Two recent cases have relied on constitutional principles of commercial speech in permitting manufacturers to promote new uses of drugs to physicians, based on medical articles, and new health claims for dietary supplements, with disclosures such as the lack of approval by the Food and Drug Administration, but without the testing or scientific acceptance for the claims that would otherwise have been necessary. This Article examines the adequacy of disclosure to prevent consumer deception, ensure safety, and provide research incentives. The Article also explores the reasons for using an intermediate review standard to govern the constitutionality of new claims on approved products and a more deferential constitutional standard to govern the availability of the product at all. Lastly, the Article suggests that courts address, in the first instance, statutory issues and the adequacy of the Agency's reasons for its administrative action. Judicial review on administrative grounds provides a type of intermediate review that may make it unnecessary to reach the constitutional issues with respect to commercial free speech.
About the Author
Margaret Gilhooley. Professor of Law, Seton Hall Law School. B.S. Fordham University; LL.B. Columbia Law School. I served in the Office of Chief Counsel of the Food and Drug Administration from 1975 to 1981. I also was a member of the presidentially appointed Commission on Dietary Supplement Labels, whose report is cited in Part III, infra.
Citation
74 Tul. L. Rev. 815 (2000)