Mifepristone Paternalism at the FDA.

This article explores the role of the Food and Drug Administration (FDA) in drug approval and restrictions to mifepristone access in the context of historical regulation and current litigation.

Information Opacity in Biopharmaceutical Innovation Through the Lens of COVID-19.

The COVID-19 pandemic has revealed myriad and complex challenges for our national health care system spanning preparedness, response, access, costs, infrastructure, coordination, and medical innovation. These challenges implicate federal, state, and local agencies and actors, as well as international collaborative bodies. One constant throughout the pandemic has been the pressing need for safe and effective diagnostics, prophylactic vaccines, and drug treatments to counter the virus.

COVID-IP: staring down the Bayh-Dole Act with 2020 vision.

As the human and economic toll of the COVID-19 coronavirus steadily escalates, there is extreme uncertainty regarding the timeframe for prevention, detection, and treatment. There is also concern about the eventual costs associated with approved products and the barriers to access created by the patent system. Industry, government, and academic collaborations are leading the charge in the discovery race, partnerships which have triggered calls for the activation of the federal governments so-called ``march-in rights'' established in the Bayh-Dole Act.

Regulating Nanomedicine at the Food and Drug Administration.

The US Food and Drug Administration (FDA) oversees safety and efficacy of a broad spectrum of medical products (ie, drugs, biologics, and devices) under the auspices of federal legislation and agency regulations and policy. Complex and emerging nanoscale products challenge this regulatory framework and illuminate its shortcomings for combination products that integrate multiple mechanisms of therapeutic action. This article surveys current FDA regulatory structures and nanotechnology-specific guidance, discusses relevant nanomedicine products, and identifies regulatory challenges.

21 Century Citizen Pharma: The FDA & Patient-Focused Product Development.

Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration ("FDA"). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA's activity in drug, biologic, and medical device regulation over the course of the last one hundred plus years. The most recent fundamental reframing of the agency's authority and directive presented itself in the 21 Century Cures Act, reflecting an important role for patient perspectives in the regulatory process.

The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the United States Healthcare System.

Alongside the constitutional controversy ultimately addressed by the Supreme Court, the colossal Patient Protection and Affordable Care Act (ACA) ushered in a new paradigm for regulation of biologics by the Food and Drug Administration (FDA). Nestled within the expansive ACA, the Biologics Price Competition and Innovation Act (BPCIA) set forth an abbreviated pathway to market for "biosimilar" and "interchangeable" biological products. While the current BPCIA implementation debate focuses chiefly on the scope of scientific and technical assessments by the FDA and the effect on the emergent biosimilar industry, two issues will prove essential for determinations of access to and costs of the resulting products: how the biosimilar and interchangeable biosimilar biologics are to be named, and whether pharmacist substitution is appropriate for products the FDA deems interchangeable.

Electronic cigarettes: smoke-free laws, sale restrictions, and the public health.

Consumer use of e-cigarettes is rising despite a lack of rigorous safety testing, manufacturing controls, and a well-understood risk profile. Many states and municipalities have prohibited e-cigarette sale to minors or amended their smoke-free laws to restrict public use. I discuss the public health impact of e-cigarettes and the current lack of Food and Drug Administration regulation, and advocate that states and localities reexamine their smoke-free laws and sale restrictions to appropriately regulate public use and youth access.

No sisyphean task: how the FDA can regulate electronic cigarettes.

The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette.

Foreword: Follow-on Biologics: Implementation Challenges and Opportunities.

This Book of the Seton Hall Law Review presents the contributions to Follow-On Biologics: Implementation Challenges and Opportunities, a one-day roundtable event hosted by Seton Hall University School of Law in the fall of 2010. The roundtable fostered an international dialogue regarding the future of follow-on biologics in the United States resulting from the Patient Protection and Affordable Care Act of March 2010. THE BIOLOGIC PRICE COMPETITION AND INNOVATION ACT OF 2010.

Developing U.S. oversight strategies for nanobiotechnology: learning from past oversight experiences.

The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Department of Agriculture (USDA), Occupational Safety and Health Administration (OSHA), and National Institutes of Health (NIH).

Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology.

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological.

An integrated approach to oversight assessment for emerging technologies.

Analysis of oversight systems is often conducted from a single disciplinary perspective and by using a limited set of criteria for evaluation. In this article, we develop an approach that blends risk analysis, social science, public administration, legal, public policy, and ethical perspectives to develop a broad set of criteria for assessing oversight systems. Multiple methods, including historical analysis, expert elicitation, and behavioral consensus, were employed to develop multidisciplinary criteria for evaluating oversight of emerging technologies.

The law of incidental findings in human subjects research: establishing researchers' duties.

Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance.

Managing incidental findings in human subjects research: analysis and recommendations.

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research.

Decoding the research exemption.

While debate continues as to whether genetic sequences, which many argue represent natural phenomena rather than inventions, should be subject to standard patent protections, issuance of patents that claim DNA sequences remains common practice. In an attempt to insulate researchers from patent claims that could hinder scientific progress, many countries have provided general exemptions for scientific research. However, there is no international consensus about the extent of required protections, and even existing exemptions vary widely in clarity and are limited in practical application.