Erika Lietzan Publications

Academic Journals

The Uncharted Waters of Competition and Innovation in Biological Medicines, 44 FLORIDA STATE UNIVERSITY LAW REVIEW __ (forthcoming 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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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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Thoughts on Preemption in the Wake of the Levine Decision, 13 JOURNAL OF HEALTH CARE LAW AND POLICY 225 (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

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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

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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)

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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 Drug Innovation Paradox, University of Missouri School of Law Legal Studies Research Paper No. 2017-12.

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The U.S. Biosimilar Pathway Nearly Three Years Later, GxP LIFELINE (Dec 2012)

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Biosimilar Regulation: Important Considerations and Global Developments, PLC LIFE SCIENCES HANDBOOK (CROSS-BORDER) (2011)

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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)

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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)

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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)