Erika Lietzan *
Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA’s standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States “gold standard” for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. To them, it seems like nothing more than a sudden and significant price increase in a drug that was already widely available.
This reverse sequence happens regularly. Doctors all over the country prescribe medicines for a variety of ailments, not realizing the medicines are supposed to be approved by the FDA—but have not been. Every time a company finally does the research that the FDA requires and enjoys the reward of exclusivity in the marketplace, the public cries foul. Today doctors administer fecal microbiota therapy, using an unapproved stool preparation that has been shipped by a company in Massachusetts. But companies are studying new drugs based on the principle. A recent New York Times article described the looming controversy, quoting doctors and patients who seem to question whether the new drug approval process will be worth its cost.
These scenarios force us to confront basic questions about the cost and the benefit of the new drug framework. This article examines the new drug authorities with fresh eyes, with the added benefit of these unusual scenarios where in a sense the gatekeeping mechanism has failed. Its principal insights are that, in addition to ensuring the production of high quality evidence about treatments in the marketplace, the new drug authorities: (1) ensure the disclosure—and provide a mechanism for close regulation of the disclosure—of that information, and (2) give federal regulators a leash on new drugs, and the companies who market them, through the life cycle of those drugs. It explores the costs of error and delay associated with new drug approval and alternatives that some scholars and policymakers have proposed, ultimately arguing that—though aspects may need tweaking—the new drug approval paradigm is worthwhile.
But these access-before-evidence scenarios bring home the point that the new drug approval standard does not, itself, ensure high quality innovation is performed. Something else must provide the encouragement. It concludes that those who object to temporary exclusivity for new medicines that complete the approval process (and the high prices they make possible for a while) must ask themselves whether they value the new drug framework (including good evidence) as much as they thought.
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* Associate Professor of Law, University of Missouri School of Law. In June 2015, Diane Hoffmann and coinvestigators from the University of Maryland Baltimore received a grant from the National Institute for Allergy and Infectious Diseases to study legal and regulatory aspects of microbiota transplantation. The author served on an expert working group convened to advise the investigators from December 2015 through February 2018. This project was supported by the Joe Covington Faculty Research Fellowship and the William F. Sutter Faculty Research Fellowship Fund. The author is grateful for feedback from audience members at the sixth annual fall conference of Scalia Law School’s Center for the Protection of Intellectual Property (IP for the Next Generation of Technology, in October 2018) and for the opportunity to discuss this project at a symposium hosted by Mizzou Law’s Center for Intellectual Property & Entrepreneurship (Protecting the Public While Fostering Innovation and Entrepreneurship: First Principles for Optimal Regulation in February 2019). Krista Carver, Joseph Gabriel, Brook Gotberg, Thomas Lambert, and Patricia Zettler provided helpful comments. Henry Adams (University of Missouri School of Law Class of 2020) and Alec Larsen (Class of 2019) provided research assistance.
David S. Cohen *
In 1985, Justice Brennan did something that had never been done before and has, surprisingly, never been done again—penned a separate opinion from the Court’s left vigorously arguing for the protection of gay rights under the Constitution. Since then, even though the Court has repeatedly protected gay rights, none of the Court’s liberal Justices have said a word on the topic. Rather, the liberal Justices have ceded the territory on the issue of the Constitution and gay rights almost entirely to Justice Kennedy’s notoriously flowery but somewhat vacuous statements about the issue, as well as the pointed and often homophobic critiques of the Court’s more conservative Justices.
This liberal silence has been costly. Court developments around gay rights have been one of many factors contributing to the drastic change in this country with respect to accepting gay people and treating them more equally. Concurring opinions could have been a part of this judicial influence, both in society and in lower court doctrine, but the liberal Justices have opted to remain silent. By doing so, they have lost an opportunity to use separate opinions to influence the trajectory of the law on gay and trans rights, solidify the societal and legal gains that may be threatened by Justice Kennedy’s departure from the Court, clarify Justice Kennedy’s vague analysis, and counter the stereotypes and bigotry of the dissenting opinions.
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* Professor of Law, Drexel University Thomas R. Kline School of Law. Thank you to Professor Leonore Carpenter for her valuable feedback on this article, as well as to Sarah Varney and Alice Thornewill for excellent research assistance.
Melissa L. Breger *
All people harbor implicit biases—which by definition, are not always consciously recognized. Although trial judges are specifically trained to compartmentalize and shield their decisions from their own biases, implicit biases nonetheless seep into judicial decision making. This article explores various strategies to decrease implicit bias in bench trials. Questions are then raised about whether a judge who has faced bias personally would be more amenable and more open to curbing implicit bias professionally. Ultimately, does diversifying the trial court judiciary minimize implicit bias, while also creating a varied, multidimensional judicial voice comprised of multiple perspectives? This article will explore this potential interplay between diversifying the trial court judiciary and reducing implicit bias, while urging future quantitative research.
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* Professor of Law, Albany Law School. J.D., 1994, University of Michigan Law School; B.S., 1991, University of Illinois at Urbana-Champaign. Thank you to Judge Rachel Kretser who invited me to present a very early iteration of this article in March 2017 during a conference entitled, Balancing the Scales of Justice: The Impact of Judicial Diversity after the screening of the Pioneering Women Judges documentary. Thank you to the audience at Boston University’s Diversity & Law Association for inviting me to present this paper in April 2017. I am grateful for the feedback on earlier drafts by Professors Deseriee Kennedy, Jean Sternlight, Christine Sgarlata Chung, and Beverly Moran. Many thanks for the excellent research assistance of Ashley Milosevic, Nicole Finn, Konstandina Tampasis, and Robert Franklin.
Karen Oehme *
Nat Stern **
Although the legal profession has recognized the importance of improving attorneys’ mental health, it has largely ignored recent social and scientific research on how adverse childhood experiences (“ACEs”) can harm attorneys’ long-term well-being. This article reviews the science of ACEs and argues that law schools and the legal profession should educate law students and attorneys about the impact of prior trauma on behavioral health. Without such education, law schools and the legal system are missing a crucial opportunity to help lawyers prevent and alleviate the maladaptive coping mechanisms that are associated with ACEs. Until such knowledge is widespread, many lawyers will be plagued by their own trauma histories—to the detriment of individuals, families, communities, and the legal system.
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* Director, Institute for Family Violence Studies, and Distinguished University Scholar, Florida State University.
** John and Ashley E. Frost Professor of Law, Florida State University College of Law.
Peter K. Yu *
Written in celebration of the seventieth anniversary of the Universal Declaration of Human Rights, this article calls for greater methodological engagement to refine existing human rights approaches to intellectual property and to devise new approaches to advance the promotion and protection of human rights in the intellectual property area. This article begins by briefly recapturing the past two decades of scholarship on intellectual property and human rights. It documents the progress scholars have made in this intersectional area. The article then draws on the latest research on human rights methods and methodology to explore whether and how we can take the academic discourse to the next level. It highlights three dominant research methods that have been used in this intersectional area: comparative methods, quantitative assessments, and contextual analyses. The second half of this article identifies the contributions a robust discourse on intellectual property and human rights can make to the future development of the intellectual property regime, the human rights regime, and the interface between these two regimes. Responding to critics and skeptics in the intellectual property field, the article concludes by explaining why human rights discussions in the intellectual property area will provide important benefits to the future development of the intellectual property regime, especially in relation to developing countries.
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* Copyright © 2019 Peter K. Yu. Professor of Law, Professor of Communication, and Director, Center for Law and Intellectual Property, Texas A&M University. This article benefited from discussions with the participants of a number of events at which the author explored issues at the intersection of intellectual property and human rights, including the Annual Meeting of the Norwegian Copyright Society in Oslo, Norway, the Third Business and Human Rights Scholars Conference at Santa Clara University School of Law, the “Global Genes, Local Concerns” Symposium at the University of Copenhagen in Denmark, a workshop organized by the International Centre for Trade and Sustainable Development in Geneva, Switzerland, the 4th International Intellectual Property Scholars Roundtable at Duke University Law School, the International Law Weekend 2014 at Fordham University School of Law, the Workshop on “Patent Regimes and the Right to Science and Culture” at Yale Law School, and the “Intellectual Property and Human Rights” Conference at American University Washington College of Law. The author is grateful to the participants of these events for their valuable comments and suggestions
Carly M. Celestine – Symposium Editor, Volume 53
The University of Richmond Law Review is incredibly excited to present its 2019 Symposium Issue: The 50th Anniversary of the Fair Housing Act–Past, Present, and Future. Each year, the Law Review hosts a Symposium which seeks to critically examine and debate a specific area of law. This year, we celebrated the fiftieth anniversary of the Fair Housing Act (“FHA”). We were honored to host an outstanding assembly of scholars and practitioners to re- flect on the social and legal precursors to the FHA, evaluate its impact to date, and anticipate the role of the Act in providing equal access to housing in the future.
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Richard Sander*
Twenty-first century America is witnessing a broad and unprecedented migration of middle and upper-middle class families to old, dense, and often low-income urban neighborhoods. This “new urban migration” has the potential to create wholly gentrified neighborhoods that displace existing residents, or to engender racially and economically integrated neighborhoods that strengthen both neighborhoods and central cities. I argue that valuable lessons can be learned from the 1970s, when another large intraurban migration—the vast metropolitan movement of black households into white neighborhoods that followed passage of the Fair Housing Act—produced patterns of resegregation in many cities, but genuine housing integration in others. We now understand what conditions in the 1970s produced resegregative or integrative outcomes. I show that so far, the new urban migration has mostly fostered integration, but that careful, proactive policies that help to disperse this migration can make good long-term outcomes much more likely.
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*Professor of Law, UCLA, and Director, UCLA-RAND Center for Law and Public Policy. Ph.D. (economics), Northwestern University, 1990; J.D., Northwestern University, 1988; B.A., Harvard University, 1978.
Allison K. Bethel*
In 2018, we celebrated the fiftieth anniversary of the Fair Housing Act which outlawed discrimination in residential transactions. When the FHA was passed, the home search process was very different. Fifty years ago, most people searched for housing by viewing listings in newspapers and other printed publications or perhaps used a realtor. Today, most people use the internet to search for housing. Home sharing, where all or part of a home is rented on a short-term basis, has become very popular since 2008 when Airbnb entered the market. It has become a multimillion dollar business and proponents see great potential in it to ease housing and income shortages. As home sharing has grown in popularity, racism has reared its ugly head and reports of dis- crimination against minority guests have become all too frequent. Complaints of housing providers refusing to rent based on the race, sexual orientation, religion, or other protected characteristics of prospective guests have gained widespread attention through social media and threaten to undermine the future of the concept.
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* Clinical Professor of Law and Director of the John Marshall Law School’s Fair Housing Legal Clinic, Chicago, Illinois. J.D., University of Florida; B.S., Northwestern University. Prior to joining JMLS in 2008, the author served as Director of Civil Rights for the Florida Attorney General’s office and litigated fair housing cases on behalf of the state. Prior to joining the Attorney General’s office, the author worked in private practice as a civil trial lawyer and defending fair housing cases.
The author gratefully acknowledges the support of John Marshall colleagues Professor Debra Stark, mentors Professors Michael P. Seng and F. Willis Caruso, Raizel Liebler, Head of Faculty Scholarship Initiatives, and research assistant Benjamin Lee.
Valerie Schneider*
One of the harshest collateral consequences of an arrest or conviction is the impact a criminal record can have on one’s ability to secure housing. Because racial bias permeates every aspect of the criminal justice system as well as the housing market, this collat- eral consequence—the inability to find a place to live after an arrest or conviction—disproportionately affects minorities.
In 2016, after decades of appearing to encourage local public housing providers to adopt harsh policies barring applicants with criminal records, the Office of General Counsel for the United States Department of Housing and Urban Development (“HUD”) issued guidance instructing public and private housing providers to take in to account the potentially disparate effects of such policies on racial minorities (the “HUD Guidance”). Recognizing that African Americans and Latinos are “arrested, convicted and in- carcerated at rates disproportionate to their share of the general population,” HUD advised that any policy that “restricts access to housing on the basis of criminal history” may have an unlawful disparate impact based on race.
The HUD Guidance on the potentially disparate impact of the use of criminal background checks has remained in place, though it is expected to be rolled back like many other Obama-era policies; thus, the question has now become how municipalities and housing providers will interpret and give effect to the HUD Guidance. This article examines how one such municipality—the District of Columbia—has grappled with putting the HUD Guidance into effect via legislative changes.
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* Associate Professor of Law, Howard University School of Law. J.D., 2006, George Washington University Law School; B.A., 1998, University of Pennsylvania.
The author expresses gratitude to Dean Holley-Walker and the Howard University School of Law, which funded her research through a summer stipend, and to the individual members of the Howard University School of Law faculty who provided feedback in the early stages of drafting. Additionally, the author would like to thank Professor Carol Brown and the University of Richmond Law Review for putting together a thought-provoking symposium on the Fiftieth Anniversary of the Fair Housing Act. Finally, the author thanks her excellent research assistant, Candace Caruthers, for her thorough and thoughtful work.
Michael Diamond*
In this essay, I examine the types of costs that are imposed on society as a whole due to the absence of a sufficient number of decent housing units that are affordable to the low-income population. These costs present themselves in relation to health care, education, employment, productivity, homelessness, and incarceration. Some of the costs are direct expenditures while others are the result of lost opportunities.
My hypothesis is that these costs are significant and offer, at the very least, a substantial offset to the cost of creating and subsidizing the operation of the necessary number of affordable housing units that are currently missing. I suggest a series of reasons why, in the face of this potentially inefficient outcome, the market/society does not produce the required units.
The essay is conceptual in nature, not empirical. I recognize the issues associated with the quantification of often opaque costs and with their causal relationship to the lack of affordable housing. It is clear, however, that the costs are sizable and the correlations are strong and therefore, I believe, the hypothesis requires empirical study.
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Professor of Law, Georgetown University Law Center. I would like to acknowledge the generous contributions of Josh Teitelbaum, David Hyman, and Gregg Bloche who, through several discussions with each, helped me to refine ideas presented here. I would also like to acknowledge the valuable research assistance of Gabriel Angelo Quevedo and the tremen- dous editing support of Betsy Kuhn.
