By Richard Epstein Bad News On December 14, 2012, the US Food and Drug Administration granted an accelerated approval to the drug Ponatinib, which is used to treat patients with serious and life threatening forms of leukemia. Unfortunately, the risks associated with the use of the drug have proved to be far greater than anticipated. …
By Aditya Gupta By a detailed order passed last week, the Indian Patent Office rejected an application for compulsory license filed by a generic drug manufacturer BDR Pharmaceuticals International Pvt. Ltd. (“BDR”) seeking a license of Bristol Myers Squibb’s (“BMS”) Indian patent for an anti-cancer drug. The Indian Patent Office found that BDR had not made out…
By The Petrie-Flom Center Please join the Petrie-Flom Center for a lecture by Neil Flanzraich on responsible pricing strategy, access to care, clinical trial design, outsourcing, and other topics that raise thorny but crucial issues for pharmaceutical and biotechnology companies. There will be substantial time for Q&A. Mr. Flanzraich graduated from HLS in 1968, and was appointed…
By Kate Greenwood Cross-Posted at Health Reform Watch On April 3, 2013, the First Circuit issued decisions in three cases in which third-party payers sought compensation from Pfizer for damages sustained as a result of fraudulent pharmaceutical promotion. The decisions were noteworthy because in them the First Circuit lent its imprimatur to a causal chain…
By Christopher Robertson The Economist has a long, detailed, and readable piece about the difficulties of inferring anything from the published findings of biomedical science. There are all sorts of problems that fall short of scientific fraud, including the the biases caused by industry-funding of biomedical science, the biases of unblinded raters who see what they…
By The Petrie-Flom Center Healthcare Compliance Certification Program 2014 Health Law Student Scholarships Seton Hall University School of Law Center for Health & Pharmaceutical Law & Policy The Healthcare Compliance Certification Program is a multi-day educational program that addresses the myriad of legal and compliance issues faced by the pharmaceutical and medical device industries. Purpose: This award recognizes…
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…
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…
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…
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….
