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Food and Drug Administration

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Full-Text Articles in Law

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman Jan 2023

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …


Statutory Interpretation And Agency Disgorgement Power, Caprice L. Roberts Nov 2022

Statutory Interpretation And Agency Disgorgement Power, Caprice L. Roberts

Journal Articles

What happens when obstacles foreclose claims and threaten to leave parties without adequate relief? Or, when the cause of action escapes conventional classification? Or, when Supreme Court decisions frustrate private litigation causing pressure for public enforcement by agencies? Or, when individuals engage in novel forms of wrongdoing that the law may fail to reach? It becomes hard to resist the siren call of equity and its powerful remedies. This trend includes sweeping national injunctions, constructive trusts, and more. Disgorgement is also one such remedy, and its popularity is rising in terms of private and public applications and challenges. It is …


Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina Jan 2022

Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina

Scholarship@WashULaw

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers.

Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications …


Insulin Federalism, Jordan Paradise Jan 2021

Insulin Federalism, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.


Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider Jan 2021

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …


Second Thoughts On Fda's Covid-Era Mental Health App Policy, Michael Mattioli Jan 2021

Second Thoughts On Fda's Covid-Era Mental Health App Policy, Michael Mattioli

Articles by Maurer Faculty

As the coronavirus pandemic swept across the globe in April 2020, the US Food and Drug Administration (FDA) made an unusual decision. The agency announced that it would relax its enforcement of compliance rules for “digital therapeutics”—smartphone apps designed to address mental health disorders. The measure was a response to widely reported upticks in symptoms of anxiety, depression, and substance abuse brought on by the pandemic. As an added benefit, the agency explained, digital therapeutics could promote social distancing by removing patients’ need to visit health care providers.

This essay explores the possible lasting effects of the FDA’s temporary suspension …


Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise Jan 2020

Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise

Faculty Publications & Other Works

In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug …


Comments On The Preliminary Framework For Equitable Allocation Of Covid-19 Vaccine, Ana Santos Rutschman, Julia Barnes-Weise, Robert Gatter, Timothy L. Wiemken Jan 2020

Comments On The Preliminary Framework For Equitable Allocation Of Covid-19 Vaccine, Ana Santos Rutschman, Julia Barnes-Weise, Robert Gatter, Timothy L. Wiemken

All Faculty Scholarship

On September 1, 2020 the National Academies released a draft framework for Equitable Allocation of a COVID-19 Vaccine. In this response, we analyze the proposed framework and highlight several areas.

Among the proposed changes, we highlight the need for the following interventions. The final framework for distribution of COVID-19 vaccines should give a higher priority to populations made most vulnerable by the social determinants of health. It should incorporate more geography-based approaches in at least some of the four proposed phases of vaccine distribution. It should address the possibility of a vaccine being made available through an emergency use authorization …


The Problem With Relying On Profit-Driven Models To Produce Pandemic Drugs, Ana Santos Rutschman Jan 2020

The Problem With Relying On Profit-Driven Models To Produce Pandemic Drugs, Ana Santos Rutschman

All Faculty Scholarship

The longstanding problems of relying on a market response to a pandemic are becoming readily apparent in the United States, which has quickly become the epicenter of the COVID-19 outbreak. The problems are particularly pronounced in pharmaceutical markets, where we are pinning our hopes for both cures and vaccines. In previous work we have shown how characteristics of healthcare markets in the United States create a divergence between the private incentives of for-profit companies and public health needs, leading to sub-optimal health outcomes in what is a uniquely market-driven healthcare system. In this Essay, written as the COVID-19 pandemic unfolds, …


Why The Government Shouldn't Pay People To Get Vaccinated Against Covid-19, Ana Santos Rutschman Jan 2020

Why The Government Shouldn't Pay People To Get Vaccinated Against Covid-19, Ana Santos Rutschman

All Faculty Scholarship

As several pharmaceutical companies approach the Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19. This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is likely to remain …


Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens Jan 2020

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …


Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman Jan 2020

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 …


Medical Ai And Contextual Bias, W. Nicholson Price Ii Sep 2019

Medical Ai And Contextual Bias, W. Nicholson Price Ii

Articles

Artificial intelligence will transform medicine. One particularly attractive possibility is the democratization of medical expertise. If black-box medical algorithms can be trained to match the performance of high-level human experts — to identify malignancies as well as trained radiologists, to diagnose diabetic retinopathy as well as board-certified ophthalmologists, or to recommend tumor-specific courses of treatment as well as top-ranked oncologists — then those algorithms could be deployed in medical settings where human experts are not available, and patients could benefit. But there is a problem with this vision. Privacy law, malpractice, insurance reimbursement, and FDA approval standards all encourage developers …


Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder Jan 2019

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

  • The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
  • Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
  • Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …


Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs Sep 2018

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.


Drug Approval In A Learning Health System, W. Nicholson Price Jul 2018

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 …


Serving Up Allergy Labeling: Mitigating Food Allergen Risks In Restaurants, Marie C. Boyd Jan 2018

Serving Up Allergy Labeling: Mitigating Food Allergen Risks In Restaurants, Marie C. Boyd

Faculty Publications

Allergens in restaurant food cause many allergic reactions and deaths. Yet no federal, state, or local law adequately protects people from these harms. Although federal law requires the labeling of “major food allergens” in packaged food, there are no allergen labeling requirements for restaurant-type food. In addition, existing food safety requirements for restaurants are inadequate to prevent allergen cross contact.

The existing legal scholarship on food allergens in restaurants is limited. Much of the legal scholarship on labeling in restaurants focuses on menu labeling — the provision of calorie and other nutrition information to combat obesity. The requirements of Section …


Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen Jan 2018

Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen

Articles

In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article were …


Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii Nov 2017

Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …


Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai Mar 2016

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …


The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah Jan 2014

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …


Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson Jan 2014

Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson

Law Student Publications

This article explores whether a graphic warning is possible or preferable in the government's fight against tobacco. Part II outlines a brief history of tobacco regulation in the United States. Part III turns to the Family Smoking Prevention and Tobacco Control Act (FSPTCA) and the FDA's initial rulemaking process. Part IV outlines the doctrine of commercial free speech, and Part V discusses why the Rule faced insurmountable challenges under this jurisprudence. Part VI explores how the FDA may overcome these hurdles in its future rulemaking, while Part VII discusses alternative methods through which the government can pursue its anti-tobacco agenda …


Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio Jan 2014

Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio

Law Student Publications

This comment argues that the FDA should regulate ecigarettes, but in doing so, it should take a minimalist approach to regulation. Instead of continuing its attempts to regulate tobacco products under the drug and device provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), an incredibly stringent statute, the FDA should focus its efforts under the Tobacco Control Act ("TCA"), which is tailored specifically to regulate tobacco products. While the FDA has extensive regulatory options under the TCA, much of this authority should not be applied to ecigarettes. Part II will provide background information on ecigarettes generally as well …


Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai Jan 2012

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai

Faculty Scholarship

The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms.

In contrast, this Perspective uses the lens …


Honey, It’S All The Buzz: Regulating Neighborhood Beehives, Patricia E. Salkin Jan 2012

Honey, It’S All The Buzz: Regulating Neighborhood Beehives, Patricia E. Salkin

Scholarly Works

Beekeeping’s popularity has surged in recent years, perhaps culminating in the introduction of the first ever White House bee hive. Local Apiaries provide a wide variety of benefits to communities, ranging from pollination services for gardens to producing honey that can be used in a wide array of foods and products. Apiaries are not always welcome in a community, however, perhaps because of their potential to cause a nuisance, or to harm crops or people. Although beekeeping regulation implicates both state and federal concerns a number of localities have developed unique and practical regulations that promote backyard beekeeping, while maximizing …


The Case For Legal Regulation Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff Jan 2011

The Case For Legal Regulation Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

No abstract provided.


Two Masters, Carl E. Schneider Jan 2010

Two Masters, Carl E. Schneider

Articles

American government rests on the principle of distrust of government. Not only is power within the federal government checked and balanced. Power is divided between the federal government and the state governments. So what if a state law conflicts with a federal law? The Constitution says that the "Constitution, and the Laws of the United States ... shall be the supreme Law of the Land; ... any Thing in the ... Laws of any State to the Contrary notwithstanding." Sometimes the conflict between federal and state law is obvious and the Supremacy Clause is easily applied. But sometimes ...


High Crimes, Not Misdemeanors: Deterring The Production Of Unsafe Food, Rena I. Steinzor Jan 2010

High Crimes, Not Misdemeanors: Deterring The Production Of Unsafe Food, Rena I. Steinzor

Faculty Scholarship

In the fall of 2008, Minnesota public health officials became alarmed by an unusually high number of illnesses and deaths caused by salmonella poisoning. Federal and state regulators and the news media eventually traced the outbreak back to products supplied by the Peanut Corporation of America (PCA). Employees shipped batches that tested positive for salmonella from a plant with a leaking roof, mold growing on ceilings and walls, rodent infestation, filthy processing receptacles, and feathers and feces in the air filtration system. Under an agreement with the Food and Drug Administration (FDA), Georgia state inspectors visited the PCA plant nine …


The Obstacles Of Outsourcing Imported Food Safety To China, Chenglin Liu Jan 2010

The Obstacles Of Outsourcing Imported Food Safety To China, Chenglin Liu

Faculty Articles

Outsourcing regulatory power through a bilateral agreement with China is unlikely to ensure the safety of imported food for two primary reasons: (1) shifting the regulatory burden does not present a feasible alternative to the traditional enforcement tools of outcome-based and production-based inspections and sanctions; and (2) China's burgeoning food safety regime, based on an entirely different culture and legal system, provides little incentive for Chinese food manufacturers to increase production costs to comply with U.S. standards.

There are three approaches for securing food safety in the U.S.: (1) increase inspections at the borders by utilizing traditional outcome-based enforcement tools; …


The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness Jan 2010

The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness

Law Faculty Scholarly Articles

On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. In …