The fallout from KV Pharmaceuticals' pricing of its new drug Makena has gone beyond complaints from patients and doctors. Minnesota Sen. Amy Klobuchar and Ohio's Sen. Sherrod Brown are calling for a federal investigation into "price gouging" after KV slapped a $1,500-per-dose price tag on Makena, a newly-approved form of hormone injection used to prevent premature births.
Compounding pharmacies had been producing unapproved versions of the injection for pregnant women at $10 to $20 a pop. So, the now-FDA-approved version--the only one legally available now under FDA exclusivity rules--runs up to 150 times that.
The calls for a Federal Trade Commission probe come after Brown dispatched a letter to KV last week, asking the company to reconsider Makena's pricing. "KV created an overnight monopoly for this lifesaving drug--and then proposed raising the price by 14,900 percent," he said in a statement. "[T]o date the company continues to defend this astronomical price increase."
KV did go out on a limb--and spent lots of money--to run trials on Makena and then to jump through FDA's approval hoops. What's more, the FDA has been encouraging companies to commercialize old meds that are now only available in unapproved versions. But Brown notes that federal grants helped finance Makena's development, too.
- see the release from Brown's office
- get the Minneapolis-St. Paul Business Journal story