By Nicholson Price Drug prices have been making waves in the news recently. The most recent case is the huge price hikes of the EpiPen, which provides potentially life-saving automatic epinephrine injections to those with severe allergies. Mylan, which makes the EpiPen, has raised its price some 450% over the last several years. The EpiPen…
By Shailin Thomas Recently, the American Medical Association (“AMA”) passed an emergency resolution at its annual conference declaring gun violence a public health crisis and calling for both restrictions on access to firearms and increased research into gun-related violence. In its announcement, the AMA noted that it plans to “actively lobby Congress to overturn legislation…
By Timo Minssen New publication on the patentability of biomedical diagnostics out: Abstract: This brief comment complements Dan Burk’s excellent paper ( Dolly and Alice, J Law and the Biosciences (2015), 1–21, doi:10.1093/jlb/lsv042 ) by providing a very brief summary of the European approach regarding patents on medical diagnostic methods. This serves as the basis for…
This new post by Nancy Beaulieu, Michael Chernew, Soren Kristensen, and Meredith Rosenthal appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016. The notion that the American health care system should transition from paying for volume to paying for…
By John Tingle One thing is clear when commentating on patient safety developments in the UK is that there is hardly ever a dull moment or a lapse of activity in patient safety policy development .Something always appears to be happening somewhere and it’s generally a very significant something. Things are happening at a pace…
By John Tingle Healthcare providers and policy makers can avoid the expense of reinventing the wheel if they try and look beyond their shores for solutions to patient safety problems. In the UK the work of the patient safety unit of WHO in Geneva helps NHS healthcare providers through the development of patient safety tools…
By Elizabeth Guo Pharmaceutical companies are making breakthrough drugs to cure diseases, but no one knows how to pay for them. In 2013 and 2014, FDA approved Solvaldi and Harmoni, which can cure hepatitis C in more than 90% of patients. Solvaldi and Harmoni cost $84,000 and $95,000, respectively, for a standard course of treatment.…
By Michael Anne Kyle Most readers of this blog will be familiar with the story of Sovaldi (sofosbuvir), a breakthrough treatment for Hepatitis C. Sovaldi is a transformative cure for a devastating disease, but priced at $84,000 per 12-week course, it has distressed insurance budgets (particularly Medicaid) and in many instances, led to rationing of…
By Academic and Clinical Research Group at Verrill Dana LLP [Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog] To rely or not to rely? Under the recent Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human…
By Timo Minssen The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines? Some advice on how to address the particular challenges and opportunities in interdisciplinary research are described in our recent…
