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 biologics—monoclonal…
By Kate Greenwood [Cross-posted at Health Reform Watch] Late last year, the Columbia Law Review published David Freeman Engstrom’s Private Enforcement’s Pathways: Lessons from Qui Tam Litigation, the fourth in a series of articles Professor Engstrom has written on the growth and evolution of qui tam litigation. (My colleague Associate Dean Kathleen Boozang wrote about the…
By Kate Greenwood [Cross-posted at Health Reform Watch] A week ago, the Food and Drug Administration announced the results of a review of the medical literature it conducted in response to “recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.” The literature, FDA determined, is inconclusive. FDA found that…
[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Carl Coleman. This post was cross-posted at Health Reform Watch.] By Carl H. Coleman With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments. Earlier this month,…
By Kate Greenwood [Cross-posted at Health Reform Watch] As I have blogged about before, including last year here, research and public health interventions aimed at preventing stillbirth are stymied by a dearth of data. In an article in this month’s Maternal and Child Health Journal, Erica Lee and colleagues at New York City’s Bureau of Vital…
By Kate Greenwood[Cross-posted at Health Reform Watch] As I have blogged about before, last year, in Kaiser v. Pfizer, the First Circuit joined the handful of courts to have approved a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which…
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 Benefit…
By Kate Greenwood [Cross-posted at Health Reform Watch] Given the health law and policy topics that are this blog’s usual fare, some of you may have missed the fact that earlier this month the eighty-eighth annual Miss America pageant was held here in New Jersey, at Boardwalk Hall in Atlantic City. And you may have also…
By Kate Greenwood [Cross-posted at Health Reform Watch] In recent months, advocates have alleged that discrimination on the basis of health status in health insurance continues, notwithstanding the Affordable Care Act’s attempts to level the playing field for people with chronic health conditions. How the government and industry should respond to the allegations is not clear,…
[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Tara Adams Ragone. This post was cross-posted at Health Reform Watch.] By Tara Adams Ragone Social media recently focused my attention on two very different law enforcement interactions with people with mental illness that reinforce the need for…
