(Larry Downing/Reuters)
Last week we
found out about KV Pharmaceutical and its exclusive approval from the FDA to sell the drug Makena, a premature birth preventive progesterone drug. While the drug had been made in compounding pharmacies for years, and provided for about $20 an injection, KV Pharmaceutical decided, since they had the advantage of monopoly, to use it and hike the price of the drug to $1,500 an injection.
Sen. Sherrod Brown jumped in, sending a letter to the CEO of KV urging the company to reverse course. He also requested an antitrust investigation of the company's practices with the Federal Trade Commission, and called for a federal investigation of what the price hike would mean for the Medicaid program. Most effectively, at a hearing March 30 with Health and Human Services Secretary Kathleen Sebelius, Brown pushed for FDA action. And got it.
The Food and Drug Administration took the unusual step Wednesday of inviting specialty pharmacies to make an end run around a company that obtained exclusive rights to a pregnancy drug and promptly raised the price from $20 a dose to $1,500....
In its statement, the FDA noted that the drug was important and K-V "received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug's effectiveness."
KV had contacted pharmacies, "threatening that the FDA would punish them if they compounded their own versions of the drug." The FDA just said it would do no such thing. In response, KV has said they would "do more" to bring down the cost of their own drug. Sometimes raising hell works. No fooling.