By I. Glenn Cohen Should litigants in products liability or other litigation be able to subpoena data from clinical trials to help prove their case? Does it matter whether the clinical trial is ongoing, finished recruiting but still analyzing data, or published? Michelle Mello and I have an invited commentary on this issue in JAMA…
By Nadia N. Sawicki Did HHS shoot itself in the foot by providing an accommodation to religious non-profits? In holding that the contraceptive mandate imposed by HHS on Hobby Lobby and Conestoga Wood was not the “least restrictive alternative” for providing no-cost contraceptive coverage to women, the Supreme Court pointed to the accommodation HHS recently provided…
By Nadia N. Sawicki Courts evaluating First Amendment and RFRA claims have long held that they are in no position to evaluate the validity, centrality, or reasonableness of a claimant’s sincere religious beliefs. And while there is room for courts to evaluate whether a claimant’s beliefs are indeed “sincere,” many courts shy away from doing so…
By The Petrie-Flom Center Post-Trial Responsibilities: Ethics and Implementation Thursday, September 18, 2014 Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave. This event is free and open to the public, but due to limited seating registration is required. Please register online. Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in…
By Bob Bohrer Cross-post from Pharmaceutical Policy There were two stories in The New York Times that, although not directly related, are the basis for today’s post. The first, by Andrew Ross Sorkin, Do Drug Companies Make Drugs, or Money?,appeared in the Business Section on page B1 on June 3, 2014. The second, by Andrew Pollock, New System for…
By The Petrie-Flom Center The Journal of Law and the Biosciences, the new open-access journal launched this year by the Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has published several articles in recent weeks by Harvard Law School students: Nicholas Meyers, Cook v. FDA and the importation and release of lethal injection…
By Timo Minssen In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees…
By The Petrie-Flom Center The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium: Emerging Issues and New Frontiers for FDA Regulation Monday, October 20,…
Please join us for a day-long conference at Harvard Law School on September 18, 2014, which will include presentations by leading experts and varied stakeholders as well as small group discussion and break out sessions that will work toward developing consensus in this difficult area. Key questions include: How should post-trial access be defined? What type of interventions…
By Arthur Caplan Art Caplan has a new opinion piece up at NBC News on Colorado’s new “right to try” law, which “expands access to experimental medications, making it legal for the terminally ill to seek access to drugs that have not yet received FDA approval.” From the article: Colorado has become the first state to enact a so-called…
