By Timo Minssen Dear readers and colleagues, I would like to take this opportunity to wish you all a very happy, healthy and peaceful year 2016. Reaching the end of 2015, I cannot stop thinking about the year that has passed. Being a native German, living in Sweden and commuting every week over the bridge to Copenhagen in Denmark…
By Arthur Caplan A new piece by Bill of Health contributor Art Caplan on NBC News: Should we care about Martin Shkreli, the man I call the “Wolf of Pharma Street”? His hoodie-wearing perp walk sparks outrage, but he is diverting attention from far bigger and more important systemic problems regarding the cost of drugs…
By Rachel Sachs Last week, I blogged here about the introduction of the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text) by Senators Ted Cruz and Mike Lee. As I noted, the Act would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a…
By Rachel Sachs On Thursday, Senators Ted Cruz and Mike Lee introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text), which would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a particular list of countries, including EU member countries, Japan, and Canada….
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 Dalia Deak Last week, Pfizer and Allergan announced a $155B merger that has the health care and policy world talking. The contours of the deal—in particular, where the new company will be based and the implications it has for the company’s tax rate— have raised important questions. Pfizer is a company with a long…
By Maayan Sudai Earlier this year, the flibanserin pill, aka “,” was introduced to the market, generating tons of headlines. After many years in which the plain old (male) Viagra was the sole sexual stimulator in the market, flibanserin was finally approved last August, following an 18-6 vote by the FDA advisory committee. Before approval, flibanserin was rejected…
By Dalia Deak Yesterday, the Centers for Medicare & Medicaid Services (CMS) issued a notice that affirmed CMS’s commitment to provide prescription drugs to beneficiaries, specifically highlighting beneficiaries suffering from hepatitis C virus (HCV). The notice comes at a moment of heightened interest in the cost of prescription drugs (particularly on the federal level as…
By Peng Zhao China’s Standing Committee of the National People’s Congress (NPC), the country’s legislature, will hold a meeting from October 30 to November 4 to review the authorization of the State Council, the central government, to carry out a pilot program that will introduce market authorization holder of drug (MAH) system and reform the drug registration system. On August…
Dates: October 28 – 29, 2015 Location: The New York Academy of Sciences, 7 World Trade Center, NYC Presented by: NYU School of Medicine and the New York Academy of Sciences Event URL: www.nyas.org/CompassionateUse Explore challenges surrounding pre-approval access to investigational medicines through a series of debates featuring prominent representatives of governments, pharmaceutical companies, patient groups,…
