By Nicolas Terry and Frank Pasquale Subscribe to TWIHL here! Loyola Chicago law professor Jordan Paradise joins us to discuss some of her recent work in life sciences law. Jordan’s recent interests span nanotechnology, synthetic biology, precision medicine, gene editing, and electronic cigarettes. Her publications have appeared in both peer-reviewed and legal publications. We start with a review of some of the…
2017 Annual Conference Call for Abstracts: Transparency in Health and Health Care – Legal and Ethical Possibilities and Limits April 28, 2017 Wasserstein Hall, Milstein East ABC (2036) Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for…
By Wendy S. Salkin I. Our Bodies, Our Body Politic On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews….
By Zack Buck In the ongoing fight to control the cost of health care, new understanding of the phenomenon of financial toxicity could play a vital role. Seen currently in the long-term cancer context, recent studies (here and here, and discussed here and here) have shown that individuals experiencing financial distress as a result of the cost…
By Timo Minssen I am happy to announce that our recent paper on “Standards, Data Exchange and Intellectual Property Rights in Systems Biology” has been published in the Biotechnology Journal Vol 11, Issue 12, pp. 1477-1480. The paper was co-authored by Esther Van Zimmeren from the University of Antwerp, Berthold Rutz from the European Patent Office and me. Please…
By Rachel Sachs, Washington University in St Louis[Originally published on The Conversation] Martin Shkreli. Valeant Pharmaceuticals. Mylan. These names have become big news, but just a year ago, most Americans devoted little time and attention to the question of pharmaceutical pricing. Now, a Kaiser Health Tracking Poll released Oct. 27 suggests many people care more about the…
By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq. The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of…
By Arthur Caplan A new piece by Bill of Health contributor Art Caplan in Forbes: Nathan Nascimento thinks that right-to-try laws aimed at the terminally ill are sound public policy. He is wrong. Mr. Nascimento’s commentary misrepresents the complexities of the drug development process and the issues surrounding granting access to experimental medicines before they have…
By Nicolas Terry and Frank Pasquale This week we welcome Melinda J. Beeuwkes Buntin, Chair of the Department of Health Policy at Vanderbilt University’s School of Medicine. She previously served as Deputy Assistant Director for Health at the Congressional Budget Office (CBO), and worked at the Office of the National Coordinator for Health IT. At RAND, Melinda served as…
By Rachel Sachs This morning, the FDA finally reached a decision in the closely watched case of Sarepta Therapeutics and its drug for the treatment of Duchenne Muscular Dystrophy (DMD). The FDA granted accelerated approval to Sarepta’s drug, Exondys, on the condition that Sarepta complete a new trial demonstrating the drug’s clinical effectiveness. As regular…
