James Love is joining Bill of Health as a regular contributor. James Love is the Director of Knowledge Ecology International, where his research focuses on the production, management and access to knowledge resources, and aspects of competition policy. This includes work on the financing of R&D, intellectual property rights, prices for and access to new…
Cross-posted from the CRITical Thinking blog. By Jeanie Kim The “right to try” (RTT) movement presents a narrative that pits patients against the FDA. Supporters of RTT, powered by the libertarian Goldwater Institute, have pushed for laws that let terminally ill patients bypass regulators to access unapproved treatments. As of September 2017, 37 states have enacted RTT laws.…
By Rachel Sachs Yesterday, it was announced that Allergan had transferred the ownership of the patents on its billion-dollar drug Restasis, used for the treatment of chronic dry eye, to the Saint Regis Mohawk Tribe. The Tribe then exclusively licensed the drug back to Allergan, in exchange for tens of millions of dollars in both…
By Clíodhna Ní Chéileachair Last year Médecins Sans Frontières (MSF) refused free vaccinations for pneumonia from Pfizer, who had offered the medicines as a corporate donation to the humanitarian organisation. The explanation MSF provided (available here) makes for an interesting, if uncomfortable read. Looming large is the lengthy history of negotiations between MSF with the…
By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries for papers…
By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries for papers identified…
Join us at the Centre for Information and Innovation Law (CIIR) Faculty of Law, University of Copenhagen on 20 November, 2017 to discuss Legal Perspectives on Synthetic Biology and Gene Editing. CALL FOR PAPERS Emerging technologies in Synthetic Biology and Gene Editing offer incredible opportunities and promising solutions to some of the most urgent challenges faced by…
By Abraham Gutman The legal status of medical marijuana in the United States is unique. On one hand, the Controlled Substance Act of 1970 classifies marijuana as a Schedule I drug with no acceptable medical use and high potential for abuse. On the other hand, as of February 1, 2017, 27 states and the District of…
By Christopher Robertson The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA. In response, companies have asserted that promotions are a form of speech, protected by the First Amendment. Speech…
By Shailin Thomas Earlier this month, the FDA announced that it is asking Endo Pharmaceuticals to remove the opioid Opana ER from the market. Opana ER is an extended-release pain reliever often abused by those who take it. While opioid abuse is nothing new, and many opioids leave those who take them addicted to narcotics or…
