Margaret Gilhooley

Professor Margaret Gilhooley

Emeritus Professor

Professor Gilhooley came to Seton Hall Law School in 1981 and has taught Food and Drug Law, Administrative Law and Torts. She has published widely in the areas of Food and Drug Law and Administrative Law, with an emphasis on commercial speech, drug safety, preemption, deregulation and dietary supplements.  She was appointed by President Clinton to the Commission on Dietary Supplement Labels. She testified before the House Committee on Government Reform on issues concerning dietary supplements and health claims.

Professor Gilhooley received her undergraduate degree from Fordham University, magna cum laude, and her law degree from Columbia University, magna cum laude, where she was a member of the Law Review. In addition to practicing law at Debevoise & Plimpton, she was an associate Chief Counsel for the U.S. Food and Drug Administration, and an attorney and consultant for the Administrative Conference of the United States.  She has served as a member of the Council of Administrative Law Section of the American Bar Association, and as a member of the editorial board of the Food and Drug Law Journal.  She was a member of the Committee on Academic Freedom and Tenure of the Association of American Law Schools, and of the AALS Special Committee on the Ethical and Professional Responsibilities of Law Professors.  She is an elected member of the American Law Institute.

While Professor Gilhooley retired in June 2009, she plans to continue to comment and write about FDA related issues.



Drug Safety and Commercial Speech:  Television Advertisements and Reprints on Off-Label Uses, Vol. 47-3, San Diego L. Rev. (August 2010)

Addressing Potential Drug Risks:  The Limits of Testing, Risk Signals, Preemption, and Drug Reform Legislation, 59 South Carolina Law Rev. 347 (2008)

Vioxx's History and the Need for Better Procedures and Better Testing, 37 Seton Hall L. Rev. 941 (2007)

The Impact and Limits of the Constitutional Deregulation of Health Claims on Foods and Supplements: From Dementia to Nuts to Chocolate to Saw Palmetto, 56 Mercer L. Rev. 683 (2005)

FDA and the Adaptation of Regulatory Models, 49 St. Louis Univ. L.J. 131 (2004)

Reexamining the Labeling for Biotechnology in Foods:  The Species Connection, 82 Nebraska L. Rev. 1088 (2004)

Drug Regulation and the Constitution After Western States, 37 U. Richmond L. Rev. 3 (2003)

Constitutionalizing Food and Drug Law:  When Avoidance is Right, 38 Houston L. Rev. 1383 (2002)

Tobacco Unregulated:  Why the FDA Failed, and What to Do Now, 111 Yale L. J. 1179 (2002)

Deregulation and the Administrative Role:  Looking at Dietary Supplements, 62 Montana l. Rev. 85 (2001)

Constitutional Food and Drug Law, 74 Tulane L. Rev. 815 (2000)

When Drugs are Safe for Some But Not for Others:  The FDA Experience and Alternatives for Products Liability, 36 Houston L. Rev. 927 (1999)

The Administrative Conference and the Progress of Food and Drug Reform, 30 Arizona State L. J. 129 (1998)

Herbal Remedies and Dietary Supplements: The Boundaries of Drug Claims and Freedom of Choice, 49 Florida L. Rev. 663 (1997)

Broken Back:  A Patient's Reflections on the Process of Medical Necessity Determinations, 40 Villanova L. Rev. 153 (1995)

Executive Oversight of Administrative Rulemaking:  Disclosing the Impact, 25 Indiana L. Rev. 299 (1991)

Innovative Drugs, Products Liability, Regulatory Compliance and Patient Choice, 24 Seton Hall L. Rev. 299 (1991)

Learned Intermediaries, Prescription Drugs and Patient Information, 30 St. Louis University L. J. 633 (1986)


Drug Preemption and the Need to Reform the FDA Consultation Process, 34 Amer. J. of Law & Med., 535 (2008)

Heal the Damage:  Prescription Drug Consumer Advertisements and Relative Choices, 38 health L.J. 1 (2005)

Pharmaceutical Drug Regulation in China, 44 Food Drug & Cosmetic L. J. 12 (1989)

Plain Meaning, Absurd Results and the Legislative Purpose:  The Interpretation of the Delaney Clause, 40 Administrative L. Rev. 267 (1988)


Standards and Procedures for the Discretionary Distribution of Federal Assistance, 3 Reports and Recommendations of the Administrative Conference of the United States 38, 422 in support of Recommendation 74-2 adopted by the Administrative Conference of the United States (1974)


Full list of presentations available in Curriculum Vitae

Presentation to a Delegation from the Chinese FDA on Drug Preemption at the Yale School of Public Health, (September, 2009)

The Battle over Drug Preemption Reaches the Supreme Court:  How Wide the Impact? Presentation at Health Law Professors Conference, Drexel University Law School, (June 6. 2008)