With the Threat of an Ad Ban Looming, Pharma is Fighting to Repair Its Reputation – Under Fire from Washington, Again,

Media InterviewNewspaper Article
ADWEEK
Publication year: March 27, 2016

Stacey Lee is  quoted about the American Medical Association’s request for stronger drug company advertising guidelines.

Untested Drugs to Treat Ebola: A Case of Uncompassionate Compassionate Use?

Journal paper
Stacey B. Lee
OH. N. UNIV. L. REV., Vol. 42, No. 2 (Spring 2016)
Publication year: 2016

Drug Shortage Crisis: What Happens When Generic Manufacturers “Just Say No,”

Journal paper
Stacey B. Lee
OR. L. REV. Vol. 93 No. 2, 355 – 402 (2014)
Publication year: 2014

Business and Law – Legal, Practical and Ethical Skills Make Business Law Graduates Stand Out in the Corporate World, BALT. SUN, July 7, 2013

Newspaper Article
Linda Estreson
BALT. SUN, July 9, 2013
Publication year: July 7, 2013

Stacey B. Lee quoted regarding thoughts on the importance of legal and ethical reasoning for business school graduates.

No Warning Needed, NATURE MEDICINE, Aug. 8, 2011

Magazine Article
Elie Dolgin
NATURE MEDICINE, (August 8, 2011)
Publication year: August 8, 2011

Stacey B. Lee quoted on reaction to and implications of  Supreme Court Ruling on Pliva v. Mensing.

Midday with Dan Rodricks, Analysis and Reactions to the Supreme Court’s Ruling on President Obama Affordable Care Act, NPR Affiliate, June 28, 2012

Media Interview
WYPR - a NPR Affiliate, June 28, 2012
Publication year: June 28, 2012

NPR-LogoScreen

 

Hour long discussion on reaction to the  Supreme Court’s decision regarding the Affordable Care Act.

Employment Libel and Privacy Law, MEDIA LAW RESOURCE CENTER 50 STATE SURVEY

Book Chapter
Gary B. Eidleman & Stacey L. Boyd
Employment Libel and Privacy Law, MEDIA LAW RESOURCE CENTER 50 STATE SURVEY 32-40 (Media Law Resource Center, ed., 1999) pp. 32-40.
Publication year: 1999

Evidentiary Issues in Sexual Harassment Litigation, LITIGATION IN SEXUAL HARASSMENT

Book Chapter
Harriett E. Cooperman & Stacey L. Boyd
Evidentiary Issues in Sexual Harassment Litigation, LITIGATION IN SEXUAL HARASSMENT 322-347 (Matthew B. Schiff & Linda C. Kramer, eds., 2d ed.1999).
Publication year: 1999

Commentary, Harbinger of Informed Consent Protection Parity?: Abdullahi v. Pfizer and the Alien Torts Statute

Op-ed
Stacey B. Lee
ASLME Scholars Section website
Publication year: 2011

Editorial, Drug Users Need Protection, BALT. SUN, July 7, 2011

Op-ed
Stacey B. Lee
BALT. SUN, July 7, 2011
Publication year: 2011

Perspective, Access Denied, ONE Magazine, Spring/Summer 2013

Magazine Article
Stacey B. Lee
ONE Magazine (Spring/Summer 2013)
Publication year: 2013

Editorial, FDA Proposal Could Right a Supreme Court Wrong, BALT. SUN, Dec. 3, 2013

Op-ed
Stacey B. Lee
BALT. SUN, Dec. 3, 2013
Publication year: Dec. 3, 2013

Is A Cure on the Way? – The Bad Medicine of Citizen Petitions, Generics, and Noerr-Pennington Immunity

Journal paper
Stacey B. Lee
20 KAN. J.L. & PUB. POL’Y, 98-126 (Fall 2010)
Publication year: 2010

generic_pill_300_255

This Article explores the regulatory and adjudicatory impact of brand-name drug manufacturers’ use of the governmental processes to delay the availability of generic drugs. In the current environment, brand-name drug manufacturers can engage in a two-tiered approach to extend their market share with little fear of facing antitrust liability. On the administrative agency level, manufacturers can file baseless petitions that can delay a generic drug’s approval for six months or longer. If the FDA determines the petition is meritless, these manufacturers can avoid antitrust liability by relying on Noerr-Pennington immunity. While this Article recommends a robust application of the sham exception, even a reconfigured Noerr-Pennington doctrine cannot provide a complete solution. This Article argues that agency reforms are necessary to effectively curb this type of abuse. The Food and Drug Administration Amendments Act of 2007  is an initial step in that direction.  This Article suggests ways to build on that foundation and more fully engage the FDA in actively policing the integrity of its own processes.

Informed Consent: Enforcing Pharmaceutical Companies’ Obligations Abroad

Journal paper
Stacey B. Lee
12 HEALTH & HUM. RTS: INT’L. J. 15-28 (2010).
Publication year: 2010

 

sick child article image

The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international
tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the “right to health.” This article concludes that by building on the federal appellate court’s ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

Using Mind Mapping To Bridge The Gap In Teaching Health Law To Non-Law Students

Journal paper
Stacey B. Lee
21 ANNALS HEALTH L. 281-290 (2012).
Publication year: 2012

MINDMAPPING

This pedogological approach allows me to use case law to highlight the natural associations between legal issues raised in the medical and business communities. Mapping transforms the academic exercise of case briefing into a multi-dimensional analysis that more closely mirrors the complex strategic challenges business students will face throughout their careers. It is my experience that whether created by me or by teams, mapping cases increases student comprehension of health law and improves class discussions. This occurs in large part because creating case maps invites students to think about the legal issues in a contextual way that incorporates policy, political, economic, business, and social considerations.

Pliva v. Mensing: Generic Manufacturers’ Unfortunate Hand

Journal paper
Stacey B. Lee
12 YALE J. HEALTH POL’Y L. & ETHICS 209-263 (Summer 2012).
Publication year: 2012

Generic-Drug-Label-Failure-To-Warn-Wright-Schulte-LLC

This Article explores the unfortunate hand that PLIVA dealt generic drug consumers and proposes a framework to increase the odds that generic drug consumers are provided with safe, effective, and adequately labeled generic drugs. To fully understand how PLIVA recasts the generic manufacturers’ safety obligations to consumers, this Article begins with a discussion about the approval process for brand-name and generic drugs and the corresponding manufacturer responsibilities. In particular, this Article focuses on manufacturers’ post-approval responsibilities. Next, the discussion examines how PLIVA substantively alters generic manufacturers’ post–approval responsibilities and weakens the safety provisions in the drug-labeling framework. This Article then explores the implications this compromised framework could have on consumers, patients, physicians, pharmacists, and states. This Article offers a regulatory framework to remedy the deficiencies created by PLIVA. In doing so, the argument addresses anticipated criticisms and illustrates how the proposed framework fulfills the Hatch-Waxman Act’s goal of providing consumers with safe generic drugs.

Can Incentives to Generic Manufacturers Save Doha’s Paragraph 6?

Journal paper
Stacey B. Lee
44 GEO. J. INT’L L. 1387- 1421(2013).
Publication year: 2013

DOHA DEVELOPMENT AGENDA

A primary objective of the Doha Declaration was to create a process for member countries with insufficient manufacturing capabilities to access generic versions of patented drugs without violating TRIPS intellectual property standards. This year marks the tenth anniversary of the process. Referred to as the “Paragraph 6 compulsory licenses provisions,” this first and only amendment to TRIPS was intended to ensure developing countries access to affordable medicines. Over the past decade, these provisions have failed to provide the gains initially anticipated. This Article explores the reasons for this failure and suggests that an under-examined approach to reaching the Doha Declaration’s goal lies in
reframing the role of generic manufacturers in the Paragraph 6 process. More specifically, the current health challenges facing many developing countries call for a compulsory licensing framework that realigns legal and business incentives to encourage generic manufacturers to become primary drivers in delivering necessary medicines to developing countries through Paragraph 6 provisions. This Article proposes such a framework.