Step aside, FDA. Sebelius says no to over-the-counter emergency contraceptive for girls. Health and Human Services Secretary Kathleen Sebelius publicly overruled the U.S. Food and Drug Administration Wednesday, refusing to allow Plan B One-Step to be sold over the counter to teenagers under age 17. “After careful consideration of the F.D.A. summary review, I have concluded that the data submitted by Teva do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age,” she said.
No health secretary has ever publicly overruled the FDA. A political battle was brewing over the issue of Plan B for girls, and the move is likely to have political repercussions. A spokesman for President Obama said he supports her decision, but other democrats and women’s health groups aren’t pleased, to say the least.
Device stocks rebound. Shares of medical device makers including Boston Scientific, Medtronic and NuVasive have for the most part recovered from the beating they took last week when investors pulled out after the CMS unveiled a Medicare pre-reimbursement review program to be piloted in 11 states starting next month.
New tool for mobile diabetes management. Managing diabetes may get a little more convenient as the the first glucose meter for the iPhone has been cleared by the FDA and is ready to hit the U.S. market. Sanofi’s AgaMatrix Nugget allows data to be collected, analyzed and shared through the iPhone or iPad touch.
Novartis closes neuroscience center. Novartis will close its neuroscience facility in Switzerland, where the company is headquartered, following similar moves by GlaxoSmithKline and AstraZeneca. But it won’t completely abandon its neuroscience efforts — the company says it will study the genetics of psychiatric and cognitive disorders. Developing neurological drugs has become risky in a market saturated with cheap, generic drugs; many new candidates have failed after years of expensive trials.
Dabigatran’s safety review. Serious bleeding complications in patients has prompted the FDA to initiate a safety review of anticoagulant therapy dabigatran (Pradaxa).