By Ron Litman The FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC), of which I am a member, met October 12 to discuss a controversial New Drug Application (NDA) for a powerful opioid called sufentanil, manufactured by AcelRx. Like fentanyl, sufentanil is a short-acting synthetic opioid, but approximately 5 to 10 times more potent. In…
By Rahul Nayak Recently, there has been a lot of media attention on galling price hikes of generic drugs. Historically, the social contract in pharmaceutical pricing has been tolerating expensive brand-name drugs while they have been on patent (a government-granted monopoly), followed by allowing low cost generics to rush to market after patent expiration. Yet…
By Kevin Outterson The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the 4th annual bioIP Faculty Workshop on Friday April 26, 2019, at Boston University. The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and…
By Rahul Nayak News that the Centers for Medicare and Medicaid Services will allow Medicare Advantage programs to enact “step therapy” programs for drugs under Part B as part of an effort to combat rising drug prices has been making rounds in the health policy world recently. Step therapy is used by all major private…
By Jakob Wested, Timo Minssen & Esther van Zimmeren Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR). The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred…
By Rachel Sachs Earlier this week, Politico broke the news that the Centers for Medicare and Medicaid Services (CMS) had withdrawn its outcomes-based payment deal for Novartis’ CAR-T therapy, Kymriah, without public acknowledgement. The Food and Drug Administration’s approval of Kymriah in August of last year was accompanied by the announcement of a novel outcomes-based…
By John Alexander Short Dr. Monica Bharel, the Commissioner of the Massachusetts Department of Health, recently hosted a webinar panel to discuss the many consequences of the modern opioid epidemic on families. Hosted jointly by the Association of State and Territorial Health Officials (ASTHO) and The Forum at the Harvard T.H. Chan School of Public…
By Stephen Wood There were 240 million opioid prescriptions in the U.S. in 2016, a number that accounts for about 30 percent of the world’s opioid prescriptions, and is enough for one opioid prescription for every adult American. Experts believe the overprescribing of opioids is at least somewhat responsible for the current opioid crisis. This…
By Alex Pearlman Dr. Jonathan J. Darrow, an expert on FDA policy and faculty member at Harvard Medical School, spoke with Bill of Health editor Alex Pearlman this week about the new so-called “Right to Try” law, how it is different from existing regulations, and why expanded access programs will never work without thinking about resources…
By James Love The Senate HELP committee held a hearing on June 12 on “The Cost of Prescription Drugs: Examining the President’s Blueprint ‘American Patients First’ to Lower Drug Prices” where Secretary Alex Azar was the sole witness. It was a moment for the Democrats in the Senate to draw a sharp contrast with…
