By Christopher Robertson Co-blogged with University of Arizona Fellow, Jonathan Loe Breathlessly, many news outlets reported yesterday that Kim Kardashian West was in trouble with the FDA for misleading social media advertising of the drug Diclegis. For example, the reliably hyperbolic Daily Mail led with “Kim Kardashian slammed by FDA.” As followers of this blog…
By Timo Minssen I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.…
By Arthur Caplan A new piece by David Farber, Preeya Noronha Pinto, Bill of Health contributor Arthur Caplan, and Alison Bateman-House the Health Affairs blog: Over the past year, state Right-to-Try (RTT) laws that claim to enable terminally ill patients to access unapproved, experimental drugs, biologics, and devices have swept the nation. As of early May, seventeen states have enacted…
By Rachel Sachs Earlier today, the House Energy and Commerce Committee released the most recent draft of the 21st Century Cures Act, in time for it to be marked up by the Health Subcommittee tomorrow. At 300 pages, the new draft adds back in a number of provisions that were excised from the previous, 200-page…
By Aaron S. Kesselheim and Ameet Sarpatwari Cross posted from Health Affairs Blog The past decade has seen a relatively constant rate of newly approved drugs every year. The number has even jumped in the past few years. Yet, despite such encouraging trends, we are actually facing a crisis in drug innovation today. That is because many…
By Rachel Sachs Yesterday, a new discussion draft of the 21st Century Cures Act was released, just in time for today’s hearing on the draft before the House Energy and Commerce Committee. At just 200 pages (although with some sections still “to be supplied”), this version is just half the size of the previous draft. …
By Zack Buck Last week, Dr. Salomon Melgen, an ophthalmologist who practices in North Palm Beach, Florida, was indicted on Medicare fraud charges. Melgen was charged with a variety of crimes, with prosecutors alleging he falsely diagnosed patients and falsified their files. Melgen’s name may be familiar. Last year, he was reported to be the provider with the…
By Lydia Stewart Ferreira Two Canadian think tanks – the C.D. Howe Institute and the Institute for Research on Public Policy – recently issued contradicting reports on whether prescription drug plans should be age-based or income-based. As background, medications prescribed outside a Canadian hospital setting are not covered by Canada’s medicare system. They are financed…
The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich April 14, 2014 12:00 PM Harvard Law School Griswold Hall, Room 110 1525 Massachusetts Ave. Cambridge, MA [Map] Please join us for a lecture by Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussing the balance between speed and safety in FDA’s regulation of pharmaceutical…
By Kate Greenwood [Cross-posted at Health Reform Watch] This summer, the Food and Drug Administration (FDA) is expected to approve the first entries in a new class of drugs that lower patients’ low-density lipoprotein (LDL) cholesterol levels by more than half, even those patients who are already taking other cholesterol-lowering medication. The new drugs are…
