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Articles 1 - 8 of 8
Full-Text Articles in Law
A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho
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 …
India's Compulsory License Model: Increased Pharmaceutical Access And Innovation Coexist, Bela Gandhi
India's Compulsory License Model: Increased Pharmaceutical Access And Innovation Coexist, Bela Gandhi
Brigham Young University Prelaw Review
India faces a drug access issue. By using compulsory licenses India can increase access to pharmaceuticals through generics and protect innovation of pharmaceutical patents. Similarly situated countries will benefit from India’s model to improve affordable generics while requiring strict voluntary license application requirements and drug trials for biosimilars.
A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck
A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck
Marquette Intellectual Property Law Review
A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …
Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth
Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth
Marquette Intellectual Property Law Review
This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.
Drugs' Other Side Effects, Craig J. Konnoth
Drugs' Other Side Effects, Craig J. Konnoth
Publications
Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …
Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer
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 …
Computational Experimentation, Tabrez Y. Ebrahim
Computational Experimentation, Tabrez Y. Ebrahim
Faculty Scholarship
Experimentation conjures images of laboratories and equipment in biotechnology, chemistry, materials science, and pharmaceuticals. Yet modern day experimentation is not limited to only chemical synthesis, but is increasingly computational. Researchers in the unpredictable arts can experiment upon the functions, properties, reactions, and structures of chemical compounds with highly accurate computational techniques. These computational capabilities challenge the enablement and utility patentability requirements. The patent statute requires that the inventor explain how to make and use the invention without undue experimentation and that the invention have at least substantial and specific utility. These patentability requirements do not align with computational research capabilities, …
Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer
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 …