Law Commons^™

Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer

Faculty Scholarship

Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the "specialty" drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government …

Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer

Faculty Scholarship

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, James Ming Chen, Jay Dratler Jr., Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank A. Pasquale, Elizabeth A. Reilly, Jeffery Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine A. Van Tassel

Faculty Scholarship

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

21st Century Healthcare - A New Scenario Needs New Rules Of The Game, Mian Atif Saeed

Mian Atif Saeed

We are witnessing a changing paradigm of healthcare sector in view increasing pressure on governments to provide free healthcare to citizens and increasing cost-consciousness of governments/payers to address this public issue. This changing paradigm in healthcare requirements requires a holistic review of the legislative framework in which industry operates. All stakeholders and all applicable regulatory and legal frameworks need to be appraised in order to address the requirements of 21st century healthcare. Drug development is very risky, costly and lengthy process and inventors and investor deserve financial gains for their efforts. Pharmaceutical industry requires the money to keep investing back …

An Overview Of Progress In The International Regulation Of The Pharmaceutical Industry, Joan Costa-Font, Aaron Burakoff Harvard University; University Of Barcelona

The University of New Hampshire Law Review

[Excerpt] “The pharmaceutical industry, a significant source of healthcare throughout the world, has several features that distinguish it from the rest of the health industry. In the last half-century, new technology, better technological know-how, and overall economic growth have led to widespread and rapid growth in the pharmaceutical sector. Advancements in pharmaceutical research and development have led to the production of drugs that can routinely combat afflictions that, only years ago, were untreatable or even fatal. Since 1970, the average share of Gross Domestic Product (GDP) on pharmaceutical goods has increased in most Organization for Economic Cooperation and Development (OECD) …

Pharmaceuticals And Intellectual Property: Meeting Needs Throughout The World, Thomas G. Field Jr.

Law Faculty Scholarship

To the extent that most people think about patents and other forms of intellectual property at all, they tend to be aware that the owners of such property may have the legal capacity to limit market entry--without fully appreciating the extent to which products or processes that can be easily copied might otherwise be unavailable. Focusing on their function in recouping risk capital, this article will survey the types and functions of intellectual property. Then it will attend to the situation in developing countries, particularly the role of intellectual property in meeting their needs for medical products.