SELECTED PUBLICATIONS
LAW REVIEW ARTICLES
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)
OTHER JOURNAL ARTICLES
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)
OTHER PUBLICATIONS
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)
PRESENTATIONS
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)