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Full-Text Articles in Law
Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler
Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler
Faculty Publications By Year
No abstract provided.
Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler
Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler
Faculty Publications By Year
In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …
Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled
Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled
Faculty Publications By Year
No abstract provided.
Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler
Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler
Faculty Publications By Year
The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …