TOMORROW, 10/9: Greg Jaffe on Regulatory and Policy Issues Surrounding Genetically Engineered Foods
By The Petrie-Flom Center
FDA
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Read more: TOMORROW, 10/9: Greg Jaffe on Regulatory and Policy Issues Surrounding Genetically Engineered Foods -
Read more: 10/9: Greg Jaffe on Regulatory and Policy Issues Surrounding Genetically Engineered Foods 10/9: Greg Jaffe on Regulatory and Policy Issues Surrounding Genetically Engineered Foods
By The Petrie-Flom Center
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Read more: Praise for Price’s “Making Do in Making Drugs” Praise for Price’s “Making Do in Making Drugs”
Check out this nice write up of PFC Academic Fellow Nicholson Price‘s paper, Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing, over at the Written Description IP blog. Says blogger Camilla Alexandra Hrdy, “Price’s paper leads to a host of new and interesting questions, and his thorough research revealing potential shortcomings of the FDA approval…
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Read more: Government Regulation of the Practice of Medicine: How the FDA overreaches the regulation of medical practice Government Regulation of the Practice of Medicine: How the FDA overreaches the regulation of medical practice
By Richard Epstein A sound scheme of public regulation seeks to find the best way to align the incentives of public regulators with the interests of the public at large. That task has proven to be particularly acute with the U.S. Food and Drug Administration, which possesses vast powers to regulate the manufacture and distribution…
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Read more: “When Truth Cannot Be Presumed” Burning Up SSRN “When Truth Cannot Be Presumed” Burning Up SSRN
Make sure to check out “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment,” by our very own blogger – and former Petrie-Flom Center Academic Fellow – Christopher Robertson. Chris presented this paper at our annual conference last year, blogged about it here, and must really be on to…
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Read more: On Access and Accountability: Two Supreme Court Rulings on Generic Drugs On Access and Accountability: Two Supreme Court Rulings on Generic Drugs
By Marcia Boumil and Gregory Curfman In 2013 the U.S. Supreme Court issued two important rulings in cases involving the marketing of generic drugs. In Federal Trade Commission v. Actavis, the Court addressed the law governing a controversial pharmaceutical marketing practice known as reverse payment agreements, or pay for delay – a byproduct of the Hatch-Waxman…
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Read more: Drug manufacturing’s innovation problem Drug manufacturing’s innovation problem
By Nicholson Price There’s a lot of talk and research about the drug industry, including its levels of innovation, its pricing patterns, transparency of clinical trials, industry changes over time, and how the industry is and should be regulated. But one thing that usually flies way under the radar is the question of actually making…
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Read more: Intent, Legal Metaphysics, and the Regulation of Stuff Intent, Legal Metaphysics, and the Regulation of Stuff
By Christopher Robertson I recently posted my new article “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment“. The article is forthcoming next year in Boston U. Law Review, but I have plenty of time to make revisions. So I would love to get the feedback from BillofHealth readers.…
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Read more: Experiment vs. innovative treatment in bacterial transplants Experiment vs. innovative treatment in bacterial transplants
By Nicholson Price There’s a fascinating and tragic story coming to its conclusion at UC Davis, which points at the fine line between clinical innovation and experimental treatment. Two neurosurgeons just resigned, following the resignation of the med school’s dean last year. The neurosurgeons, going off anecdotal evidence that some patients with deadly glioblastomas lived…
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Read more: Lethal Injection Drug Shortage Leads to Debate Lethal Injection Drug Shortage Leads to Debate
By Nadia N. Sawicki A recent article in the New York Times (“Death Row Improvises, Lacking Lethal Mix”) described the challenges that correctional departments in death penalty states face in obtaining the drugs needed for lethal injection. The manufacturers of pancuronium bromide and pentobarbital, for example, have refused to supply drugs for execution purposes, and the…