Academic Journals
Solutions Still Searching for a Problem: A Call for Relevant Data to Support “Evergreening” Allegations with Kristina M. L. Acri, 33 FORDHAM INTELLECTUAL PROPERTY, MEDIA & ENTERTAINMENT LAW JOURNAL 788 (2023).
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The Case of the Missing Device Patents, or: Why Device Patents Matter with Kristina M. L. Acri and Evan Weidner, 33 FORDHAM INTELLECTUAL PROPERTY, MEDIA & ENTERTAINMENT LAW JOURNAL 409 (2022).
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Ignoring Drug Trademarks, 56 WAKE FOREST LAW REVIEW 945 (2021).
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Distorted Drug Patents with Kristina M. L. Acri, 95 WASHINGTON LAW REVIEW 1317 (2020).
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Early Access to Unapproved Medicines in the United States and France, with Isabelle Moine–Dupuis, 19 YALE JOURNAL OF HEALTH POLICY, LAW, & ETHICS 1 (2020).
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The “Evergreening” Metaphor in Intellectual Property Scholarship, 53 AKRON LAW REVIEW 805 (2020).
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Access Before Evidence and the Price of FDA’s New Drug Authorities, 53 UNIVERSITY OF RICHMOND LAW REVIEW 1243 (2019).
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The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling, 69 AMERICAN UNIVERSITY LAW REVIEW 823 (2019).
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The History and Political Economy of the Hatch-Waxman Amendments, 49 SETON HALL LAW REVIEW 53 (2018).
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Paper Promises for Drug Innovation, 26 GEORGE MASON LAW REVIEW 168 (2018).
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A Solution in Search of a Problem at the Biologics Frontier, 2018 UNIVERSITY OF ILLINOIS LAW REVIEW ONLINE 19 (2018).
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The Drug Innovation Paradox, 83 MISSOURI LAW REVIEW 39 (2018).
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The Uncharted Waters of Competition and Innovation in Biological Medicines, 44 FLORIDA STATE UNIVERSITY LAW REVIEW 883 (2017).
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The Law of 180-Day Exclusivity with Julia Post, 71 FOOD AND DRUG LAW JOURNAL 327 (2016).
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The Myths of Data Exclusivity, 20 LEWIS AND CLARK REVIEW 91 (2015)
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A New Framework for Assessing Clinical Data Transparency Initiatives, 18 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW 33 (2014)
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Thoughts on Preemption in the Wake of the Levine Decision, 13 JOURNAL OF HEALTH CARE LAW AND POLICY 225 (2010)
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An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009, 65 FOOD AND DRUG LAW JOURNAL 671 (2010)
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A New History and Discussion of 180-Day Exclusivity, 64 FOOD AND DRUG LAW JOURNAL 335 (2009)
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Current Regulatory and Legal Considerations for Follow-On Biologics, 85 CLINICAL PHARMACOLOGY AND THERAPEUTICS 633 (2008)
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Issues in the Interpretation of 180-Day Exclusivity, 62 FOOD AND DRUG LAW JOURNAL 49 (2007)
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Advisory Committees at FDA: The Hinchey Amendment and ‘Conflict of Interest’ Waivers, 39 JOURNAL OF HEALTH LAW 415 (2006)
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2004 Update: 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, 59 FOOD AND DRUG LAW JOURNAL 459 (2004).
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A Brief History of 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, 59 FOOD AND DRUG LAW JOURNAL 287 (2004).
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The Authority of a Court to Order Disgorgement for Violations of the Current Good Manufacturing Practices Requirement of the Federal Food, Drug, and Cosmetic Act, 58 FOOD AND DRUG LAW JOURNAL 149 (2003)
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An Overview of Canadian Privacy Law for Pharmaceutical and Device Manufacturers Operating in Canada, 57 FOOD AND DRUG LAW JOURNAL 205 (2002)
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Tax Exemptions and the Establishment Clause, 49 SYRACUSE LAW REVIEW 971 (1998/1999)
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Law and the Wisconsin Idea, 47 JOURNAL OF LEGAL EDUCATION 297 (1997)
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Anonymous Campaign Literature and the First Amendment, 21 NORTH CAROLINA CENTRAL LAW JOURNAL 144 (1995)
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Outpatient Civil Commitment in North Carolina: Constitutional and Policy Concerns, 58 LAW AND CONTEMPORARY PROBLEMS 251 (1995)
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Book Chapters/Collected Works
FDA Regulation of Biosimilars, in FDA IN THE 21ST CENTURY: THE CHALLENGES OF REGULATING DRUGS AND NEW TECHNOLOGIES (eds. Lynch and Cohen, Columbia University Press, 2015).
Federal Regulation of Clinical Research, in MEDICAL BIOTECHNOLOGY: PREMARKET AND POSTMARKET REGULATION, (ABA, 2015)
Biosimilars, in FOOD AND DRUG LAW AND REGULATION, (3rd ed., FDLI, 2015)
The Importance of the Court Decision in Pearson v. Shalala to the Marketing of Food and Dietary Supplements in the United States, in REGULATION OF FUNCTIONAL FOODS AND NUTRACEUTICALS: A GLOBAL PERSPECTIVE, (Blackwell Press and Institute of Food Technologists Press, 2004)
Books
Medical Biotechnology: Premarket and Postmarket Regulation, editor, (ABA, 2015)
Biotechnology and the Law, editor, with Eileen Smith Ewing, Hugh Butler Wellons, Robert F. Copple, Willian Neal Wofford, (ABA, 2007)
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Other Publications
Antitrust Abuses and the FDA Approval Process: Statement Before the Committee on the Judiciary’s Subcommittee on Regulatory Reform, Commercial, and Antitrust Law U.S. House of Representatives,
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The U.S. Biosimilar Pathway Nearly Three Years Later, GxP LIFELINE (Dec 2012)
Biosimilar Regulation: Important Considerations and Global Developments, PLC LIFE SCIENCES HANDBOOK (CROSS-BORDER) (2011)
Biosimilars: What US Regulators Might Learn From Others, SCRIP PHARMA LAW (12/13/2010)
Learned Intermediary Doctrine: Required by Law?, LAW360 (July 17, 2007)
Professional Journals
A Second Look at the CREATES Act: What’s Not Being Said, 17 FEDERALIST SOCIETY REVIEW 28 (2016).
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Pharmacy Compounding After the Drug Quality and Security Act, 26 HEALTH LAWYER 1 (2013/2014)
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The Evolving Regulation of Medical Device Clinical Trials in the USA, JOURNAL OF MEDICAL DEVICE REGULATION (May 2013)
Biosimilar Naming: How Do Adverse Event Reporting Data Support the Need for Distinct Nonproprietary Names for Biosimilars?, FDLI FOOD AND DRUG POLICY FORUM vol.3:no.6 (2013)
Biosimilar Law and Regulation: An Essential Guide, FDLI MONOGRAPH SERIES vol.2:no.5 (June 2011)
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How Should FDA Use Naming and Labeling to Communicate Information about Biosimilars?, FDLI FOOD AND DRUG POLICY FORUM vol.1:no.21 (2011)
FDA in Federal Court: The Agency’s Ten-Year Record, FDLI UPDATE (Feb 2008)
The Food and Drug Administration Amendments Act of 2007, 9 BIO-SCIENCE LAW REVIEW 39 (2008)
Clinical Trial Registries and Clinical Trial Results Databases, FDLI UPDATE (Sept 2005)
FDA in Federal Court: Statistics on the Agency’s Record in Recent Years, FDLI UPDATE (July/Aug 2002)
The Medicine Equity and Drug Safety Act of 2000, FDLI UPDATE (March/April 2001)
Working Papers
User Fee Programs: Design Choices and Processes, University of Missouri School of Law Legal Studies Research Paper
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