Makena was approved in February 2011, at which point the company threatened to sue compounding pharmacies if they continued to sell the drug.
But that set off a firestorm of criticism, because K-V’s price for Makena was about 100 times higher than what most compounding pharmacies were charging. A red-faced FDA then ruled that those pharmacies could keep selling the drug.
K-V responded by suing the FDA. More recently, it has also filed suit against Georgia and South Carolina, where the states’ Medicaid programs have declined to pay for Makena, but do cover the compounding pharmacies’ products.
Chicago Doc Dies Saving Kids
Donald Liu, MD, a pediatric surgeon at the University of Chicago Hospitals, was credited with sacrificing his own life while saving two children from drowning in Lake Michigan.
Liu, 50, was on a beach in southwestern Michigan with his family when he spotted two children struggling in the waves, the Chicago Tribune reported.
He helped them get to shore, but was then pulled under water himself, most likely by a powerful rip current, public safety officials said.
Another man also drowned nearby later the same day.
Tablet Scoring Goes to FDA Adcomm
The FDA’s wheels may grind slowly, but they grind exceedingly small. Case in point: tablet scoring.
Last week, the agency sought advice from an advisory committee on its regulations covering the little grooves that drugmakers sometimes cut into pills to facilitate breaking them in two.
FDA officials indicated that tablet splitting has become more prevalent in recent years, and that evidence had surfaced that tablets don’t always break evenly.
The agency is considering whether to stiffen its requirements for scoring — such as requiring that real patients be recruited to test tablet breakage and that companies perform stability testing on split sections of scored products.
It is now finalizing a guidance document for manufacturers on the topic.
Article source: http://www.medpagetoday.com/OBGYN/Pregnancy/34157