Margaret Gilhooley

Professor of Law
 SETON HALL LAW SCHOOL


(973)642-8482
SSRN Site
 
 
Biography & Scholarship
Biography
Publications
Curriculum Vitae
Courses & Syllabi
Administrative Law
Drug Innovation, Regulation & Costs
Food, Drugs & Biotechnology
Torts
Biography


Professor Gilhooley came to Seton Hall Law School in 1981 and has taught Food and Drug Law, Drug Innovation Regulation and Costs, Administrative Law and Torts. She has published in the areas of Administrative Law,  and Food and Drug Law. 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, an attorney and consultant for the Administrative Conference of the United States and an Attorney for the U.S. Office of Economic Opportunity. 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.

 
 
Publications
 

Law Review Articles

Addressing Potential Drug Risks: The Limits of Testing, Risk Signals, Preemption, and the Drug Reform Legislation, 59 SOUTH CAROLINA LAW REVIEW, 347 (2008).

Vioxx's History and the Need for Better Procedures and Better Testing, 37 SETON HALL L. REV. 941(2007).

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

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)

The Supreme Court Checks Out Drug Promotion Restrictions, 58 Food Drug L. J. 347 (2003)

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

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

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

Deregulation And The Administrative Role: Looking at Dietary Supplements, 62 Montana L. Rev. 85 (2001). 

Constitutionalizing 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). 

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

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

The Availability of Decisions and Precedents in Agency Adjudication: The Impact of the Freedom of Information Act Publication Requirements, 3 American University Administrative L/ J. 53 (1989). 

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). 

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

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

Keynote Addresses and Presentations

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, Philadelphia, P.A.

Other Professional Material

Comments to FDA on a Proposal Rule Related to Preemption (Supplemental Applications Proposing Labeling Changes for Approved Drug, Jan. 16, 2008)
FDA Comments Available Here

Draft Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved Uses of Approved Drugs or Approved or Cleared Medical Devices, Notice of Availability, 34 Fed. Reg. 9342 (Feb. 20, 2008)                      FDA Comments Available Here