Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Withdraws Guidance On Biosimilars, Conceding A Different Approach Is Needed To Get Them To Market
Stat: Frustrated At The Pace Of Biosimilar Development, FDA Yanks A Draft Guidance
In an unusual step, the Food and Drug Administration withdrew a draft guidance that was issued last fall to help companies develop biosimilar medicines that resemble brand-name biologics. By doing so, the agency acquiesced to concerns expressed in recent months by companies over some of the recommendations that were made for concocting a biosimilar, which is a nearly identical variant of a biologic medicine and is expected to provide the same result in patients. (Silverman, 6/21)
In other pharmaceutical news —
The Hill: Skyrocketing Insulin Prices Provoke New Outrage
Rising insulin costs are drawing outrage from diabetes advocates, leading to calls for greater transparency and federal oversight of the market for a drug that helps more than 7 million Americans. Insulin was first discovered nearly 100 years ago, and as newer forms of the drug have been introduced, the price has climbed. (Weixel, 6/21)
California Healthline: California Poised To Expand Access To Hepatitis C Drugs
Patrick Garcia wasn’t completely surprised when he learned recently he had hepatitis C. Until a few years ago, he had experimented with numerous drugs, injecting heroin, methamphetamine, cocaine — you name it. “I haven’t lived exactly a perfect life,” said Garcia, 43, whose mouth, hand and back were injured in a motorcycle wreck last year.Medi-Cal, California’s public health program for the poor, paid for his post-accident care and the bloodwork that led to his hepatitis C diagnosis. But it wouldn’t pay for the pricey new medications that cure the disease. (Bartolone, 6/21)
