TOP STORIES
Pharmaceutical company Amarin Pharma is suing the FDA over the issue of off label drugs by claiming the regulators policy violates free speech. Lots about this from Pharmalot, The New York Times and Forbes.
But Amarin’s lawyers insist that their case is drawn up specifically enough that it would not undermine the FDA’s power. Joel Kurtzberg, another lawyer at Cahill, says that a court could rule in Amarin’s favor but that other drug companies seeking to market outside their labels would still find themselves having to either go to court ahead of time or to make the marketing claims at the risk of regulatory action. “I don’t think it opens the can of worms that you talked about,” says Kurtzberg.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Blue Bell Creameries, the popular regional ice cream chain that recalled all of its products last month, knew that listeria was present in one of its factories as early as 2013, according to documents released by the Food and Drug Administration.
LIFE SCIENCE
Novartis said European health regulators have approved a drug for advanced lung cancer that is intended to treat patients with a specific genetic mutation.
Theranos has appointed general counsel, according to company statement. Heather King previously worked as a partner at Boies, Schiller & Flexner in its Washington, D.C. office. and has worked closely with their client, Theranos. She has also served as special assistant and policy adviser to U.S. Senator Hillary Rodham Clinton, and helped lead her campaigns.
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It looks like Julie Brown, chief financial officer at Smith & Nephew, will join Roche’s board next year.
PAYERS-PROVIDERS
Wachter on Oz and bad medical education: ” If there is a weapon against quackademic medicine it’s exposure. Toleration of quackery has become too entrenched in academic medicine for there to be a solution from within.”
It looks like Tenet is selling its Georgia hospitals.
Brigham and Women’s Hospital has formed a partnership with Rock Health, which runs a seed-stage investment fund in San Francisco. The hospital will test and may integrate digital health startup innovations as part of a three-year partnership starting this summer, according to Boston Business Journal.
TECH
Meet Healthbox’s Miami startups.
Electronic health records may not bring any added benefit to when it comes to treating Ischemic stroke patients, according to a new study in the Journal of the American College of Cardiology.
POLITICS
HHS Secretary Sylvia Mathews Burwell said that the nation is coming closer to eliminating the “shame and secrecy” around mental illnesses, in part because of Obamacare. She said new coverage rules under Obamacare are now ensuring that about 60 million people are getting behavioral healthcare — “many for the first time in their lives.”
Top Republican strategist Karl Rove says it’s time for the GOP to finally stop trying to repeal Obamacare.
A LITTLE EXTRA
This one will get very ugly for the medical industry: a blog that lists when you have an all-male panel is getting increased traction. Among their posts is this modified bingo card originally from Feministe.
The Morning Read provides a 24-hour wrap up of everything else healthcare’s innovators need to know about the business of medicine (and beyond). The author of The Read published it but all full-time MedCity News journalists contribute to its content.
