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Full-Text Articles in Law
Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim
Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim
Faculty Scholarship
In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia …
To Accommodate Or Not To Accommodate: (When) Should The State Regulate Religion To Protect The Rights Of Children And Third Parties?, Hillel Y. Levin, Allan J. Jacobs, Kavita Arora
To Accommodate Or Not To Accommodate: (When) Should The State Regulate Religion To Protect The Rights Of Children And Third Parties?, Hillel Y. Levin, Allan J. Jacobs, Kavita Arora
Scholarly Works
When should we accommodate religious practices? When should we demand that religious groups instead conform to social and legal norms? Who should make these decisions, and how? These questions lie at the very heart of our contemporary debates in the field of Law and Religion.
Particularly thorny issues arise where religious practices may impose health-related harm to children within a religious group or to third parties. Unfortunately, legislators, scholars, courts, ethicists, and medical practitioners have not offered a consistent way to analyze such cases and the law is inconsistent. This Article suggests that the lack of consistency is a troubling …