By Marc Rodwin Last year Endo Pharmaceuticals paid just under $182 million to settle a Department of Justice prosecution over its illegal marketing of Lidoderm for uses that the FDA had not approved.[1] This settlement reflects a widespread practice in which pharmaceutical firms illegally promote drugs for off-label uses. In recent years, pharmaceutical firm settlement…
By Allison M. Whelan For many years now, there has been ongoing debate about childhood vaccinations and the recent measles outbreak in Disneyland and its subsequent spread to other states has brought vaccinations and questions about communicable diseases back to the headlines. Politicians, including potential presidential candidates such as Hilary Clinton, Rand Paul, and Chris…
By Kevin Outterson This new post by Kevin Outterson appears on the Health Affairs Blog, as part of part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. Dame Sally Davies, the Chief Medical Officer of England, warns that we are approaching an…
By Lauren Taylor In recognition of how little we talk about global health, I am turning my attention back to my roots for today’s post. On Jan 22nd, Bill and Melinda Gates launched their annual letter. For those readers who live fully under a domestic health policy rock, Bill and Melinda Gates are co-chairs of…
By Nicole Hassoun Ebola is ravaging parts of Africa, yet it is not the worst health problem facing people in the region. Millions more are infected with and die every year from diseases like malaria, TB, and HIV/AIDS because they cannot access the essential medicines they need. To change this, we need to understand where…
By Kate Greenwood [Cross-posted at Health Reform Watch] Late last year, the Columbia Law Review published David Freeman Engstrom’s Private Enforcement’s Pathways: Lessons from Qui Tam Litigation, the fourth in a series of articles Professor Engstrom has written on the growth and evolution of qui tam litigation. (My colleague Associate Dean Kathleen Boozang wrote about the…
By Kate Greenwood [Cross-posted at Health Reform Watch] A week ago, the Food and Drug Administration announced the results of a review of the medical literature it conducted in response to “recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.” The literature, FDA determined, is inconclusive. FDA found that…
By Timo Minssen I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2) “Synthetic Biology & Intellectual Property Rights”: 1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ ,…
By Ryan Abbott Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit. The suit concerns Actavis’ attempt to extend monopoly…
By Rachel Sachs Last week’s issue of the New Yorker featured a terrific article about fecal microbiota transplantation, or FMT. Much of the article focused on OpenBiome, a nonprofit stool bank spun off from MIT that screens donors, processes samples, and ships them to hospitals around the country. For those who are unfamiliar with FMT,…
