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Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen
Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen
Law Faculty Scholarship
[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …
Rational Risk/Benefit Analysis Of Genetically Modified Crops, Stanley P. Kowalski
Rational Risk/Benefit Analysis Of Genetically Modified Crops, Stanley P. Kowalski
Law Faculty Scholarship
Safety concerns over the use of molecular biotechnology in the improvement of crops has generated substantial, heated and confusing debates, often driven by ideology and hysterics. Modification of crops is not new, and biotechnology (in its broadest sense) has been used for over a century to accelerate the development of new crops for food, feed and fibre, so as to meet the demands of a growing global community. The introduction of crops developed via molecular biotechnology [Genetically Modified Crops (GMCs)] represents the latest step in this inexorable innovative progression of technology. However, misinformed concern has led to a broad embrace …
Intellectual Property Management Strategies To Accelerate The Development And Access Of Vaccines And Diagnostics: Case Studies On Pandemic Influenza, Malaria And Sars, Anatole Krattiger, Stanley P. Kowalski, Robert Eiss, Anthony Taubman
Intellectual Property Management Strategies To Accelerate The Development And Access Of Vaccines And Diagnostics: Case Studies On Pandemic Influenza, Malaria And Sars, Anatole Krattiger, Stanley P. Kowalski, Robert Eiss, Anthony Taubman
Law Faculty Scholarship
Achieving global access to vaccines, diagnostics, and pharmaceuticals remains a challenge. Throughout the developing world, intellectual property (IP) constraints complicate access to critically essential medical technologies and products. Vaccines for malaria and pandemic strains of influenza, as well as diagnostic and vaccine technologies for SARS, are not only relevant to global public health but are particularly critical to the needs of developing countries. A global access solution is urgently needed. This article offers a timely case‐by‐case analysis of preliminary patent landscape surveys and formulates options via patent pools and other forms of creative IP management to accelerate development and access. …