By Alexandra Gross What does “access” really mean for the purposes of PPACA’s contraceptive coverage mandate? For two years, I’ve been enrolled in Loyola University of Chicago’s Student Health Insurance Plan, provided through a Blue Cross Blue Shield Illinois (BCBSIL) PPO plan. During this time, I have had to pay out-of-pocket for my contraceptive method…
By Bob Bohrer[Cross-posted on Pharmaceutical Policy.] According to a story by Bronwyn Mixter in Bloomberg’s BNA BIOTECH WATCH, the FDA has received at least twenty-five IND’s for biosimilar development programs. Some quick perspective on that is appropriate. Twenty-five initial IND’s for the development of new small molecule drugs for cancer or autoimmune disease would face many…
By Bob Bohrer I have previously posted on pharmaceuticalpolicy.blogspot.com about the FDA’s proposed change to the rules for generic drug labels and an estimate of the liability costs that might be incurred by the generic drug industry as a result of the proposed change. The Generic Pharmaceutical Manufactuer’s Association lobbying efforts appear to have motivated…
Emerging Issues and New Frontiers for FDA Regulation October 20, 2014 8:00 AM – 5:00 PM Alston & Bird, The Atlantic Building, 950 F Street, NW, Washington, DC 20004-1404 Registration is now open online. A limited number of free seats are available to Harvard affiliates. For more information or to request a seat, please email us…
By Kate Greenwood [Cross-posted at Health Reform Watch] Earlier this week, the Food and Drug Administration announced that it was reopening the comment periods for the two draft guidances on the use of social media to promote prescription drugs and medical devices that it released in June: Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and…
HLS Health Law Workshop: Benjamin Roin September 29, 2014 5:00 PM Griswold Hall, Room 110 (Harvard Law School) 1525 Massachusetts Ave., Cambridge, MA [Map here.] Download the Paper: Solving the Problem of New Uses by Creating Incentives for Private Industry to Repurpose Off-Patent Drugs Benjamin N. Roin is Assistant Professor of Technological Innovation, Entrepreneurship, and Strategic Management at the MIT Sloan School…
Emerging Issues and New Frontiers for FDA Regulation October 20, 2014 8:00 AM – 5:00 PM Alston & Bird, The Atlantic Building, 950 F Street, NW, Washington, DC 20004-1404 Symposium co-sponsored by the Food and Drug Law Institute (FDLI) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Please join the…
HLS Health Law Workshop: Thomas McGuire September 22, 2014 5:00 PM Griswold Hall, Room 110 (Harvard Law School) 1525 Massachusetts Ave., Cambridge, MA [Map here.] Download the Paper: Do ‘Reverse Payment’ Settlements of Brand-Generic Patent Disputes in the Pharmaceutical Industry Constitute an Anticompetitve Pay for Delay? Thomas G. McGuire, PhD, is a professor of health…
By Zachary Shapiro Hello from the Post-Trial Responsibilities conference! I will be live blogging session 2: where speakers will be providing important perspectives on PTA. Barbra Bierer is monitoring the discussion. We started with Richard Klein calling in from FDA: Richard is talking about post-trial responsibilities. He points out that there is a justice issue…
By Holly Fernandez Lynch Today, the Multi-Regional Clinical Trials Center (MRCT) at Harvard University and the Petrie-Flom Center at Harvard Law School are co-hosting a daylong conference on “Post-Trial Responsibilities: Ethics and Implementation.” We’ll be live blogging the conference here at Bill of Health, and video/slides from the conference will be available soon. The conference…
