Prof. Margaret Gilhooley is Emeritus Professor at Seton Hall University School of Law, where she taught from 1981 until her retirement in June 2009. Her teaching covered Food and Drug Law, Administrative Law and Torts, and she has published widely in the first two of those fields, with a particular emphasis on commercial speech, drug safety, preemption, deregulation and dietary supplements .
She came to the academy from government. A magna cum laude graduate of Fordham University and of Columbia Law School (LL.B., 1966), she served in the Office of the Chief Counsel of the U.S. Food and Drug Administration from 1975 to 1981, and was a member of the presidentially appointed Commission on Dietary Supplement Labels established under the Dietary Supplement Health and Education Act . That vantage point , inside the agency that writes and enforces the rules , shaped the rest of her scholarly career.
Her work interrogates the constitutional and administrative architecture of food and drug regulation rather than taking it as given. Landmark pieces include 'Tobacco Unregulated: Why the FDA Failed, and What to do Now' (Yale Law Journal, 2002), 'Constitutionalizing Food and Drug Law' (Tulane Law Review, 2000) and its companion 'Constitutionalizing Food and Drug Law: When Avoidance is Right' (Houston Law Review, 2000), 'Drug Regulation and the Constitution After Western States' (University of Richmond Law Review, 2002), and 'Addressing Potential Drug Risks: The Limits of Testing, Risk Signals, Preemption, and the Drug Reform Legislation' (South Carolina Law Review, 2008) . Her work on dietary supplements and health claims , including 'Herbal Remedies and Dietary Supplements: The Boundaries of Drug Claims and Freedom of Choice' (Florida Law Review, 1997) , has been widely cited in the ongoing debate over how far the First Amendment constrains FDA regulation .
Her articles have appeared in the Yale Law Journal, Tulane Law Review, Houston Law Review, Florida Law Review, Mercer Law Review, Nebraska Law Review, University of Richmond Law Review, Villanova Law Review, St. Louis University Law Journal, the Administrative Law Review and the American Journal of Law & Medicine, and she contributed a chapter on cosmetic regulation to the Food and Drug Law Institute's seventy-fifth anniversary volume . Though she retired in 2009, she continues to comment and write on FDA-related issues .
Prof. Gilhooley's scholarship is distinguished by a quality rare in regulatory writing: she takes the agency's own problems seriously. Having worked inside FDA's Office of Chief Counsel, she writes about preemption, risk signals and supplement labelling not as an outside critic scoring points but as someone who understands what the agency can and cannot realistically do , and what Congress and the courts should therefore require of it. Her Yale Law Journal piece on why tobacco regulation failed remains a model of that approach.
Legal manuscripts are unusually unforgiving of imprecision: a mis-cited regulation, an overstated holding, or a doctrinal step that the cases do not support will sink a submission before the substance is ever considered. Prof. Gilhooley has spent four decades reading statutes and case law at that level of exactness, and she brings it to the manuscripts APC reviews in food and drug law, administrative law and regulatory policy.
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