Erika Fisher Lietzan

University of Missouri School of Law

Missouri Avenue & Conley Avenue

Columbia, MO 65211

United States

SCHOLARLY PAPERS

15

DOWNLOADS
Rank 18,160

SSRN RANKINGS

Top 18,160

in Total Papers Downloads

2,171

CITATIONS

0

Scholarly Papers (15)

1.

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 Fisher Lietzan, Jeffrey Elikan and Krista Hessler Carver
University of Missouri School of Law, Covington & Burling and Covington & Burling
Downloads 141 (107,799)

Abstract:

biosimilars, BPCIA, biologics, Hatch-Waxman

2.

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 Fisher Lietzan
University of Missouri School of Law
Downloads 82 (197,025)

Abstract:

biosimilars, BPCIA, FDA, biologics

3.

A New Framework for Assessing Clinical Data Transparency Initiatives

Number of pages: 54 Posted: 11 Aug 2013 Last Revised: 18 Mar 2014
Erika Fisher Lietzan
University of Missouri School of Law
Downloads 40 (330,306)

Abstract:

transparency, trade secrets, clinical data, data protection

4.

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 E. Korn, Erika Fisher Lietzan and Shaw W. Scott
Pharmaceutical Research and Manufacturers of America (PhRMA), University of Missouri School of Law and Covington & Burling
Downloads 34 (275,252)

Abstract:

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

5.

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 Fisher Lietzan
University of Missouri School of Law
Downloads 18 (115,453)

Abstract:

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

6.

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 Fisher Lietzan
University of Missouri School of Law
Downloads 6 (513,708)

Abstract:

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

7.

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 Fisher Lietzan
University of Missouri School of Law
Downloads 6 (493,603)

Abstract:

advisory committees, FDA, conflicts of interest

8.

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 Fisher Lietzan and Sarah E. Pitlyk
University of Missouri School of Law and Independent
Downloads 6 (477,982)

Abstract:

preemption, FDA, products liability

Abstract:

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

10.

The Drug Innovation Paradox

University of Missouri School of Law Legal Studies Research Paper No. 2017-12
Number of pages: 77 Posted: 07 Apr 2017 Last Revised: 11 Apr 2017
Erika Fisher Lietzan
University of Missouri School of Law
Downloads 0 (30,781)

Abstract:

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

11.

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 Fisher Lietzan
University of Missouri School of Law
Downloads 0 (483,245)

Abstract:

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

12.

The Uncharted Waters of Competition and Innovation in Biological Medicines

Florida State University Law Review, Vol 44, 2017, Forthcoming, University of Missouri School of Law Legal Studies Research Paper No. 2016-27
Number of pages: 63 Posted: 06 Oct 2016 Last Revised: 25 Oct 2016
Erika Fisher Lietzan
University of Missouri School of Law
Downloads 0 (125,918)

Abstract:

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

13.

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 Fisher Lietzan
University of Missouri School of Law
Downloads 0 (240,740)

Abstract:

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

14.

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 Fisher Lietzan and Julia Post
University of Missouri School of Law and Covington & Burling LLP
Downloads 0 (59,984)

Abstract:

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

15.

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 Fisher Lietzan and Henry G. Grabowski
University of Missouri School of Law and Duke University - Department of Economics

Abstract:

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