Morning Briefing
Summaries of health policy coverage from major news organizations
Patients, Advocates To Flood FDA Panel Hearing On Experimental Muscular Dystrophy Treatment
The Boston Globe: FDA Panel Weighs Sarepta’s Experimental Drug
One of the most closely watched hearings on a proposed drug in years convenes Monday morning in Hyattsville, Md., where a panel of medical experts will consider an application by Cambridge’s Sarepta Therapeutics Inc. for approval of a Duchenne muscular dystrophy treatment. (Weisman, 4/25)
The Washington Post: To Sway Drug Approval, Patient Advocates Turn Up The Heat On The FDA
Billy Ellsworth, a teenager with an inexorable and devastating degenerative muscle disease, will bring a football with him to a Maryland hotel conference center on Monday. For months, he has been brainstorming a way to prove to a panel of scientists and physicians that the experimental drug he has been taking for more than four years has kept him strong and well — and he’d like to punctuate his brief testimony in the clearest possible way: by throwing them the ball. (Johnson, 4/23)
In other Food and Drug Administration news —
Reuters: FDA Proposes Ban On Certain Electrical Stimulation Devices
The U.S. Food and Drug Administration on Friday proposed a ban on electrical stimulation devices (ESDs) that are used to curb individuals from engaging in self-injurious or aggressive behavior, saying they pose an "unreasonable and substantial" risk to public health. (4/23)
The Associated Press: Study Refutes Warnings: No Suicide Risk For Anti-Smoking Pills Chantix, Zyban
Seven years after U.S. regulators slapped their strictest warning on two popular smoking-cessation medicines citing risks of suicidal behavior, a large international study found no such risk. (Johnson, 4/22)
