Law Commons^™

Race And Regulation Podcast Episode 6 - Race, Social Inequalities, And Clinical Drug Trials, Jill A. Fisher

Penn Program on Regulation Podcasts

As mandated by the U.S. Food and Drug Administration, clinical trials for new pharmaceuticals enroll healthy people as paid research participants to test for drug safety and tolerability. But the social injustices from these trials are too often overlooked. Drawing on her award-winning book, Adverse Events, Jill Fisher of UNC-Chapel Hill’s Center for Bioethics explains how clinical drug trials attract disproportionate participation by racial and ethnic minorities who then disproportionately assume risks of participating in these trials, often just to stay financially afloat.

Sobering Up After The Seventh Inning: Alcohol And Crime Around The Ballpark, Jonathan Klick, John M. Macdonald

All Faculty Scholarship

Objectives: This study examines the impact of alcohol consumption in a Major League Baseball (MLB) stadium on area level counts of crime. The modal practice at MLB stadiums is to stop selling alcoholic beverages after the seventh inning. Baseball is not a timed game, so the duration between end of the seventh inning (last call for alcohol) and the end of the game varies considerably, providing a unique natural experiment that allows us to estimate the relationship between alcohol consumption and crime near a stadium on game days to non-game days and to areas around sports bars that fans also …

Risk And Regulatory Calibration: Wto Compliance Review Of The U.S. Dolphin-Safe Tuna Labeling Regime, Cary Coglianese, André Sapir

All Faculty Scholarship

In a series of recent disputes arising under the TBT Agreement, the Appellate Body has interpreted Article 2.1 to provide that discriminatory and trade-distortive regulation could be permissible if based upon a “legitimate regulatory distinction.” In its recent compliance decision in the US-Tuna II dispute, the AB reaffirmed its view that regulatory distinctions embedded in the U.S. dolphin-safe tuna labeling regime were not legitimate because they were not sufficiently calibrated to the risks to dolphins associated with different tuna fishing conditions. This paper analyzes the AB’s application of the notion of risk-based regulation in the US-Tuna II dispute and finds …

Debating The Cause Of Health Disparities: Implications For Bioethics And Racial Equality, Dorothy E. Roberts

All Faculty Scholarship

No abstract provided.

Mergers, Market Dominance And The Lundbeck Case, Herbert J. Hovenkamp

All Faculty Scholarship

In Lundbeck the Eighth Circuit affirmed a district court’s judgment that a merger involving the only two drugs approved for treating a serious heart condition in infants was lawful. Although the drugs treated the same condition they were not bioequivalents. The Eighth Circuit approved the district court’s conclusion that they had not been shown to be in the same relevant market.

Most mergers that are subject to challenge under the antitrust laws occur in markets that exhibit some degree of product differentiation. The Lundbeck case illustrates some of the problems that can arise when courts apply ideas derived from models …

Antitrust And Patent Law Analysis Of Pharmaceutical Reverse Payment Settlements, Herbert J. Hovenkamp

All Faculty Scholarship

Patent settlements in which the patentee pays the alleged infringer to stay out of the market are largely a consequence of the Hatch-Waxman Act, which was designed to facilitate the entry of generic drugs by providing the first generic producer to challenge a pioneer drug patent with a 180 day period of exclusivity. This period can be extended by a settlement even if the generic is not producing, and in any event all subsequent generic firms are denied the 180 day exclusivity period, significantly reducing their incentive to enter.

The Circuit Courts of Appeal are split three ways over such …

What’S Wrong With Race-Based Medicine?, Dorothy E. Roberts

All Faculty Scholarship

This article is based on the 2010 Dienard Memorial Lecture on Law and Medicine at University of Minnesota and part of a larger book project, Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-first Century (The New Press, 2011). In June 2005, the Food and Drug Administration approved the first pharmaceutical indicated for a specific race. Its racial label elicited three types of criticism – scientific, commercial, and political. I discuss the first two controversies en route to what I consider the main problem with race-based medicine – its political implications. By claiming that race, a …

Consumer Protection In An Era Of Globalization, Cary Coglianese, Adam M. Finkel, David T. Zaring

All Faculty Scholarship

With expanding global trade, the challenge of protecting consumers from unsafe food, pharmaceuticals, and consumer products has grown increasingly salient, necessitating the development of new policy ideas and analysis. This chapter introduces the book, Import Safety: Regulatory Governance in the Global Economy, a multidisciplinary project analyzing import safety problems and an array of innovative solutions to these problems. The challenge of protecting the public from unsafe imports arises from the sheer volume of global trade as well as the complexity of products being traded and the vast number of inputs each product contains. It is further compounded by the …

Reconceptualizing Human Rights To Challenge Tobacco, Rangita De Silva De Alwis, Richard Daynard

All Faculty Scholarship

No abstract provided.

Greater And Lesser Powers Of Tort Reform: The Primary Jurisdiction Doctrine And State-Law Claims Concerning Fda-Approved Products, Catherine T. Struve

All Faculty Scholarship

No abstract provided.

The Fda And The Tort System: Postmarketing Surveillance, Compensation, And The Role Of Litigation, Catherine T. Struve

All Faculty Scholarship

The dispute over FDA regulatory preemption is familiar: Preemption advocates assert that products liability suits stifle innovation, and proponents of tort liability counter that the FDA fails adequately to protect the public and that persons injured by defective products deserve compensation. The FDA's premarket approval process cannot detect all potential safety problems with a new drug; postmarketing surveillance is essential, and the FDA's efforts in that regard fall short. Advocates of preemption will find it difficult to establish that FDA regulation should entirely displace the tort system. This article examines whether a case could be made for an intermediate approach …

Fda Reform And The European Medicines Evaluation Agency, Theodore Ruger

All Faculty Scholarship

No abstract provided.