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Articles 1 - 30 of 43
Full-Text Articles in Law
A Modest Proposal: Leveraging Private Enforcement Mechanisms And The Bayh-Dole Act To Reduce Drug Prices In The U.S. Healthcare Industry, Brittany Day
Duke Journal of Constitutional Law & Public Policy Sidebar
The United States healthcare system is one of the most expensive in the world. Unlike other products, when drug prices skyrocket, people may die. While advocating for various solutions, both the Biden and Trump administrations have recognized the importance of halting the rise of prescription drug prices. Most of the solutions advanced are focused on government-side initiatives, such as allowing Medicare to directly negotiate with pharmaceutical companies. Yet, the "march-in rights" built into the Bayh-Dole Act create an opportunity to set up a mechanism that would invite private actors to sue pharmaceutical companies for unconscionable drug pricing. The Bayh-Dole Act …
Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina
Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina
Scholarship@WashULaw
State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on …
Pricing Drugs Fairly, Govind C. Persad
Pricing Drugs Fairly, Govind C. Persad
Sturm College of Law: Faculty Scholarship
Dissatisfaction with drug prices has prompted a flurry of recent legislation and academic research. But while pharmaceutical policy often regards fair pricing as a goal, the concept of fairness itself frequently goes undefined. Legal scholarship—even work ostensibly focused on fairness—has not defined and defended an account of fair pricing. Recent legislative proposals passed by the House and proposed by Sens. Ron Wyden and Chuck Grassley have similarly avoided a determinate position on fairness. This Article explains and defends an account of what makes a price for a drug fair that identifies fair price with social value, argues for implementing fair …
A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll
A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll
Faculty Publications
Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …
Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley
Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley
Articles
As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.
Intersectionality In The Opioid Crisis: Anti-Black Racism And White, Pregnant, Opioid Users, Craig Konnoth
Intersectionality In The Opioid Crisis: Anti-Black Racism And White, Pregnant, Opioid Users, Craig Konnoth
Publications
No abstract provided.
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
All Faculty Scholarship
Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …
Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle
Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle
Articles in Law Reviews & Other Academic Journals
Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …
Drugs' Other Side Effects, Craig J. Konnoth
Drugs' Other Side Effects, Craig J. Konnoth
Publications
Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Articles
Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.
Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson
Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson
Faculty Scholarship
Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively modest federal plan to bring down drug prices. Meanwhile, several states are moving forward with their own solutions, and Maryland’s approach is particularly ambitious. In 2017, responding to notorious cases such as the 5000% increase in the cost of Daraprim (pyrimethamine) and the 10-fold increase in the cost of EpiPens (epinephrine auto-injectors), Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential …
Drug Approval In A Learning Health System, W. Nicholson Price
Drug Approval In A Learning Health System, W. Nicholson Price
Articles
The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …
On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey
On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey
Faculty Scholarship
This essay explores the role of litigation in drug safety regulation and the role of drug safety regulation in litigation, exemplified by the 2017 National Health Law Moot Court Problem. Using the example of failure-to-update claims against generic drug manufacturers, this essay argues that pharmaceutical preemption doctrine would benefit from a tailored application of the presumption against preemption. It proposes a presumption that Congress does not intend to displace historic state remedies for injury without clearly saying so, focusing on the role of remedy to account for the evolving overlap in federal and state police powers over health and to …
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Articles
In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have all been discussed as alternatives to paying strictly for volume. Manufacturers and payers have complained, however, that Medicaid’s “best-price rule” inhibits their ability to enter into these newpricing arrangements. This article examines the best-price rule and assesses to what extent, if any, it might frustrate the goal of paying for value. We conclude that the best-price rule is not as serious a problem as it …
Cancer's Ip, Jacob S. Sherkow
Cancer's Ip, Jacob S. Sherkow
Articles & Chapters
The state of publicly funded science is in peril. Instead, new biomedical research efforts — in particular, the recent funding of a “Cancer Moonshot” — have focused on employing public-private partnerships, joint ventures between private industry and public agencies, as being more politically palatable. Yet, public-private partnerships like the Cancer Moonshot center on the production of public goods: scientific information. Using private incentives in this context presents numerous puzzles for both intellectual property law and information policy. This Article examines whether—and to what extent — intellectual property and information policy can be appropriately tailored to the goals of public-private partnerships. …
Rwu First Amendment Blog: Jared A. Goldstein's Blog: Ri's Conversion Therapy Ban Protects Lgbtq Youth And It's Constitutional 08-09-2017, Jared A. Goldstein
Rwu First Amendment Blog: Jared A. Goldstein's Blog: Ri's Conversion Therapy Ban Protects Lgbtq Youth And It's Constitutional 08-09-2017, Jared A. Goldstein
Law School Blogs
No abstract provided.
Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise
Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise
Faculty Publications & Other Works
No abstract provided.
Patent Law's Reproducibility Paradox, Jacob S. Sherkow
Patent Law's Reproducibility Paradox, Jacob S. Sherkow
Articles & Chapters
Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …
The Statutory Case Against Off-Label Promotion, Nathan Cortez
The Statutory Case Against Off-Label Promotion, Nathan Cortez
Faculty Journal Articles and Book Chapters
The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …
A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort
A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort
Articles
Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed …
Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Kevin Outterson
Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Kevin Outterson
Faculty Scholarship
A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information …
Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro
Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro
All Faculty Scholarship
The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.
As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to …
Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii
Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii
Law Faculty Scholarship
Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …
Reverse Payments, Perverse Incentives, Murat C. Mungan
Reverse Payments, Perverse Incentives, Murat C. Mungan
Faculty Scholarship
Issuing and enforcing prescription drug patents requires courts and legislatures to strike a delicate balance. A patent gives drug manufacturers a legal, if temporary, monopoly on sales of a drug; this encourages manufacturers to engage in costly research and development of new medicines. But not all patents issued by the Patent Office are ultimately deemed valid – generic drug manufacturers can infringe the patent, and, when sued, attack its validity in court on a variety of grounds, including obviousness. In recent years, patent holders have begun to settle these suits (which they initiated) by paying the alleged infringer. Not surprisingly, …
Regulating Compounding Pharmacies After Necc, Kevin Outterson
Regulating Compounding Pharmacies After Necc, Kevin Outterson
Faculty Scholarship
Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA),requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting human-research subjects owe a debt to Tuskegee and Nuremberg.
With Child, Without Rights?: Restoring A Pregnant Woman's Right To Refuse Medical Treatment Through The Hiv Lens, Michael Ulrich
With Child, Without Rights?: Restoring A Pregnant Woman's Right To Refuse Medical Treatment Through The Hiv Lens, Michael Ulrich
Faculty Scholarship
In Doe v. Division of Youth & Family Services , a hospital employee sought state intervention when an HIV-positive woman refused to comply with treatment recommendations during her pregnancy to drastically reduce the chances of mother-to-child-transmission (MTCT), eventually triggering a lawsuit against the hospital. With an increase in the number of HIV-positive women becoming pregnant and the court avoiding constitutional analysis of the woman’s right to refuse medical treatment, there is a clear void where legal analysis is surely needed. This Article fills this void for the inevitable case where an HIV-positive pregnant woman’s right to refuse medical treatment is …
A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson
A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson
Faculty Scholarship
The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor.
Rethinking Addiction: Drugs, Deterrence, And The Neuroscience Revolution, Linda C. Fentiman
Rethinking Addiction: Drugs, Deterrence, And The Neuroscience Revolution, Linda C. Fentiman
Elisabeth Haub School of Law Faculty Publications
This article connects the debate about addiction with the fundamental criminal law principle of deterrence. It seeks to bridge the gap between the competing medical and criminal justice approaches by exploring addiction in light of recent research about the brain, gender differences, and what works best from both a treatment and justice perspective. To sharpen the issues, the article deliberately focuses on the emotionally freighted subject of pregnant drug users. This approach will illuminate prevailing assumptions about how biological, genetic, cultural, and other environmental factors shape human behavior and challenge conventional understandings of deterrence in light of new research on …
Preface To Fatal Invention: How Science, Politics, And Big Business Re-Create Race In The Twenty-First Century, Dorothy E. Roberts
Preface To Fatal Invention: How Science, Politics, And Big Business Re-Create Race In The Twenty-First Century, Dorothy E. Roberts
All Faculty Scholarship
Fatal Invention documents the emergence of a new biopolitics in the United States that relies on re-inventing race in biological terms using cutting-edge genomic science and biotechnologies. Some scientists are defining race as a biological category written in our genes, while the biotechnology and pharmaceutical industries convert the new racial science into race-based products, such as race-specific medicines, ancestry tests, and DNA forensics, that incorporate false assumptions of racial difference at the genetic level. The genetic understanding of race calls for technological responses to racial disparities while masking the continuing impact of racism in a supposedly post-racial society. Instead, I …
Cognition-Enhancing Drugs: Can We Say No?, Frank Pasquale
Cognition-Enhancing Drugs: Can We Say No?, Frank Pasquale
Faculty Scholarship
Normative analysis of cognition-enhancing drugs frequently weighs the liberty interests of drug users against egalitarian commitments to a "level playing field." Yet those who would refuse to engage in neuroenhancement may well find their liberty to do so limited in a society where such drugs are widespread. To the extent that unvarnished emotional responses are world-disclosive, neurocosmetic practices also threaten to provide a form of faulty data to their users. This essay examines underappreciated liberty-based and epistemic rationales for regulating cognition-enhancing drugs.