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.

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 …

Pharmaceutical Federalism, Patricia J. Zettler

Indiana Law Journal

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013, Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Global Responses: The Search For Cures In The Development Of Pharmaceuticals, Stuart R. Walker

Indiana Journal of Global Legal Studies

In this article, Professor Stuart Walker examines several challenges that

will be faced by the global pharmaceutical industry in the near future. These

involve the question of improving the overall quality of life and care for

millions in an era of cost containment. In order to respond to the increasing

demands for advances in medicine while simultaneously retaining an

industrially strong, innovative, and resilient economy, responsibility for the

necessary changes will need to be shared among governments, the

pharmaceutical industry, and health care professionals.

In particular, four challenges faced by the global pharmaceutical industry

and their responses to each are …