Law Commons^™

Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii

IP Theory

Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

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 …

Putting Paper To Pen: Generation Juul's Case For Harm Reduction, Liz Emanuel

Indiana Law Journal

Part I of this Note soberly explores and delineates the perceived and real threats of vaping for America’s youth, concluding with an analysis of the socioeconomic and developmental health effects of nicotine addiction. Part II delves into the federal government’s response to e-cigarettes as well as the powers and limitations of federal regulation under the Food and Drug Administration’s (FDA) “Deeming Rule” and the potential effectiveness of an increase in the national tobacco purchase age or a federal ban on flavored vaping products. Part III discusses the realistic benefits of taking a harm reduction approach to youth vaping in the …

A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho

Indiana Law Journal

Is more information always better? First Amendment commercial speech jurisprudence takes this as a given. However, when information is only available from a self-interested and marketing-savvy pharmaceutical company, more information may simply lead to more misinformation. Notably, doctors are also misled. This can result in public health harms when companies are promoting unapproved uses of prescription drugs that the Food and Drug Administration (FDA) has approved for other purposes—commonly referred to as “off-label” uses. Contrary to judicial presumptions, as well as the presumptions of some doctors and scholars, doctors are not sophisticated enough to always discern what is true versus …

A Corporate Duty To Rescue: Biopharmaceutical Companies And Access To Medications, Rebecca E. Wolitz

Indiana Law Journal

Controversies regarding the pricing of biopharmaceutical products are pervasive. Patients must choose between treatment and rent, prescriptions go unfilled, and health systems are forced to restrict access to life-saving medications— all because of cost. Though there is often consensus that these issues are problematic, there is disagreement as to what are appropriate solutions and who has responsibility to bring about those solutions. Most efforts to address biopharmaceutical pricing concerns focus on governmental regulation. This Article has a different focus. It provides a legal and normative analysis of a form of corporate self-regulation that could help address access and pricing concerns—a …

Securing The Internet Of Healthcare, Michael Mattioli, Scott J. Shackelford, Steve Myers, Austin Brady, Yvette Wang, Stephanie Wong

Articles by Maurer Faculty

Cybersecurity, including the security of information technology (IT), is a critical requirement in ensuring society trusts, and therefore can benefit from, modern technology. Problematically, though, rarely a day goes by without a news story related to how critical data has been exposed, exfiltrated, or otherwise inappropriately used or accessed as a result of supply chain vulnerabilities. From the Russian government's campaign to influence the 2016 U.S. presidential election to the September 2017 Equifax breach of more than 140-million Americans' credit reports, mitigating cyber risk has become a topic of conversation in boardrooms and the White House, on Wall Street and …

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.

Weiland V. Telectronics Pacing Systems, Inc.: Illinois Reexamines Medical Device Preemption, Adrian S. Allen

Indiana Law Journal

No abstract provided.

The International Conference On Harmonization Of Pharmaceutical Regulations, The European Medicines Evaluation Agency, And The Fda: Who's Zooming Who?, Dan Kidd

Indiana Journal of Global Legal Studies

No abstract provided.

The Deregulation Of Industry: How Far Should We Go?, Wesley J. Liebeler

Indiana Law Journal

Colloquium: The Deregulation of Industry

The Food And Drug Administration And The Economic Adulteration Of Foods, Wesley E. Forte

Indiana Law Journal

No abstract provided.