Erika Lietzan

University of Missouri School of Law

Missouri Avenue & Conley Avenue

Columbia, MO MO 65211

United States

SCHOLARLY PAPERS

20

DOWNLOADS
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in Total Papers Downloads

3,473

CITATIONS

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Scholarly Papers (20)

1.

The Drug Innovation Paradox

Missouri Law Review, Forthcoming, University of Missouri School of Law Legal Studies Research Paper No. 2017-12
Number of pages: 75 Posted: 07 Apr 2017 Last Revised: 09 May 2018
Erika Lietzan
University of Missouri School of Law
Downloads 847 (26,876)

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new drugs, patents, data exclusivity, clinical trials, medical innovation, health policy, empirical research, history of medicine, patent policy, patent term restoration

2.

The Law of 180-Day Exclusivity

Food & Drug Law Journal, Forthcoming, University of Missouri School of Law Legal Studies Research Paper No. 2016-17
Number of pages: 104 Posted: 31 May 2016 Last Revised: 24 Jun 2016
Erika Lietzan and Julia Post
University of Missouri School of Law and Covington & Burling LLP
Downloads 440 (63,420)

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Generics, Brand Drugs, Hatch-Waxman, Antitrust, Intellectual Property, Patents, Biosimilars, Authorized Generics, New Drugs, FDA, PTO

3.

The History and Political Economy of the Hatch-Waxman Amendments

49 Seton Hall Law Review 53 (2018), University of Missouri School of Law Legal Studies Research Paper No. 2018-20
Number of pages: 76 Posted: 15 Mar 2018 Last Revised: 19 Dec 2018
Erika Lietzan
University of Missouri School of Law
Downloads 381 (75,274)

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drugs, patents, generic drugs, patent term restoration, patent term extension, public choice

4.

The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling

68 American University Law Review 823 (2019), University of Missouri School of Law Legal Studies Research Paper No. 2019-02
Number of pages: 103 Posted: 20 Sep 2018 Last Revised: 12 Feb 2019
Sean M. O'Connor and Erika Lietzan
University of Washington - School of Law and University of Missouri School of Law
Downloads 300 (98,558)

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cannabis, marijuana, medical marijuana, FDA, food and drug law, health law, regulatory law, administrative law

5.

An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009

Food and Drug Journal, Vol. 65, No. 4, 2010
Number of pages: 149 Posted: 17 Feb 2013
Erika Lietzan, Jeffrey Elikan and Krista Carver
University of Missouri School of Law, Covington & Burling and Covington & Burling
Downloads 284 (104,567)

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biosimilars, BPCIA, biologics, Hatch-Waxman

6.

The Myths of Data Exclusivity

20 Lewis & Clark L. Rev. 91 (2016), University of Missouri School of Law Legal Studies Research Paper No. 2015-22
Number of pages: 74 Posted: 02 Sep 2015 Last Revised: 18 Sep 2016
Erika Lietzan
University of Missouri School of Law
Downloads 265 (112,537)

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pharmaceuticals, drugs, generic drugs, access to medicines, biologics, biosimilars, intellectual property, patents, exclusivity, data protection

7.

The Uncharted Waters of Competition and Innovation in Biological Medicines

44 Florida State University Law Review 883 (2017), University of Missouri School of Law Legal Studies Research Paper No. 2016-27
Number of pages: 61 Posted: 06 Oct 2016 Last Revised: 29 May 2018
Erika Lietzan
University of Missouri School of Law
Downloads 243 (123,011)

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Generic Drugs, Biosimilars, Patents, Antitrust, Coverage, Reimbursement, Substitution, Marketplace Dynamics, Competition, Medicare, Medicaid

8.

Biosimilar Law and Regulation: An Essential Guide

FDLI Monograph Series, Volume 2, Number 5, June 2011
Number of pages: 228 Posted: 20 Feb 2013
Erika Lietzan
University of Missouri School of Law
Downloads 140 (202,254)

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biosimilars, BPCIA, FDA, biologics

9.

A Second Look at the CREATES Act: What's Not Being Said

The Federalist Society Review, Volume 17, Issue 3, Forthcoming , University of Missouri School of Law Legal Studies Research Paper No. 2016-26
Number of pages: 14 Posted: 29 Sep 2016 Last Revised: 25 Oct 2016
Erika Lietzan
University of Missouri School of Law
Downloads 108 (246,097)

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Generic Drugs, Biosimilars, Antitrust, Patent, Legislation, FDA, Drug Pricing, Innovation Policy, Biologics

10.

Paper Promises for Drug Innovation

26 George Mason Law Review 168 (2018) , University of Missouri School of Law Legal Studies Research Paper No. 2018-17
Number of pages: 48 Posted: 23 Jan 2018 Last Revised: 15 Apr 2019
Erika Lietzan
University of Missouri School of Law
Downloads 99 (261,247)

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drugs, biologics, medicine, generic drugs, biosimilars, patents, exclusivity, new uses, repurposing, innovation policy

11.

A New History and Discussion of 180-Day Exclusivity

Food and Drug Law Journal, Vol. 64, No. 2, 2009
Number of pages: 57 Posted: 18 Feb 2013
David Korn, Erika Lietzan and Shaw Scott
Pharmaceutical Research and Manufacturers of America (PhRMA), University of Missouri School of Law and Covington & Burling
Downloads 84 (289,948)

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Hatch-Waxman, 180-day exclusivity, generic drugs, ANDAs

12.

A New Framework for Assessing Clinical Data Transparency Initiatives

Number of pages: 54 Posted: 11 Aug 2013 Last Revised: 18 Mar 2014
Erika Lietzan
University of Missouri School of Law
Downloads 60 (348,888)

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transparency, trade secrets, clinical data, data protection

13.

A Solution in Search of a Problem at the Biologics Frontier

2018 U. Ill. L. Rev. Online 19, University of Missouri School of Law Legal Studies Research Paper No. 2018-05
Number of pages: 17 Posted: 30 Nov 2017 Last Revised: 06 Feb 2018
Erika Lietzan
University of Missouri School of Law
Downloads 59 (351,740)

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Antitrust, Competition, Generic Drugs, Biosimilars, Patents, Exclusivity, Product Hopping, Incremental Innovation, Competition, Innovation

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FDA, Patent, Antitrust, Drug Pricing, Generic Drugs, Public Health, Transparency, Open Government

15.

Access Before Evidence and the Price of FDA's New Drug Authorities

53 U. RICH. L. REV. __ (2019) (Forthcoming), University of Missouri School of Law Legal Studies Research Paper No. 2019-02
Number of pages: 61 Posted: 05 Mar 2019 Last Revised: 11 Apr 2019
Erika Lietzan
University of Missouri School of Law
Downloads 44 (400,224)

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fecal microbiota, FDA, new drugs, tissues, blood, Hatch Waxman, orphan drugs, cost-benefit analysis, innovation

16.

Brief of 11 Professors as Amici Curiae in Support of Amgen in Amgen v. Sandoz

Number of pages: 55 Posted: 23 Mar 2017 Last Revised: 25 Mar 2017
Erika Lietzan
University of Missouri School of Law
Downloads 22 (498,494)

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biologics, medicines, innovation, patent litigation, economics, FDA, Hatch-Waxman, legislation

17.

Thoughts on Preemption in the Wake of the Levine Decision

Journal of Health Care Law & Policy, Vol. 13, No. 225, 2010
Number of pages: 32 Posted: 18 Feb 2013
Erika Lietzan and Sarah E. Pitlyk
University of Missouri School of Law and Independent
Downloads 19 (515,423)

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preemption, FDA, products liability

18.

Advisory Commitees at FDA: The Hinchey Amendment and 'Conflict of Interest' Waivers

Journal of Health Law, Vol. 39, No. 4, 2006
Number of pages: 35 Posted: 20 Feb 2013
Erika Lietzan
University of Missouri School of Law
Downloads 15 (538,236)

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advisory committees, FDA, conflicts of interest

19.

Outpatient Civil Commitment in North Carolina: Constitutional and Policy Concerns

Law and Contemporary Problems, Vol. 58, No. 2, 1995
Number of pages: 32 Posted: 21 Feb 2013
Erika Lietzan
University of Missouri School of Law
Downloads 11 (561,613)

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outpatient commitment, mental health, O'Connor v. Donaldson

20.

FDA Regulation of Biosimilars

FDA in the Twenty First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press 2015)
Posted: 17 Sep 2015
Erika Lietzan and Henry G. Grabowski
University of Missouri School of Law and Duke University - Department of Economics

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biosimilars, generic drugs, BPCIA, Hatch-Waxman, price competition, innovation, cost savings, pharmaceuticals, biotechnology