Hey, KV Phamaceuticals, that new, $1,500-a-dose drug of yours is about to get some competition!

The Food and Drug Administration said in an unusual statement that it's quite all right for pharmacists to go ahead and make their own version of the medicine, given by injection to help some women avoid preterm delivery of their babies. Many of them had been doing that for years anyway and charged $20 or less per dose.

But KV, based in St. Louis, pursued formal approval of the medicine, hydroxyprogesterone caproate, to avoid premature deliveries. Starting this month, KV began selling it as Makena at a price of $1,500 a shot. For women who need the drug, given weekly for about 20 weeks, the tab would come to around $30,000, as the Washington Post reported the other day. The price hike led to a backlash from just about everyone except KV shareholders.

Now the FDA has cleared the air about whether pharmacists can make the medicine. The agency's answer boils down to an emphatic yes.

 

Pharmacists have a lot of latitude to make their own medicines to order. Before big drug companies came on the scene with drugs made in mass quantities, pharmacists spent a lot of time mixing medicines and prepare the right doses. The practice, called compounding, is still around, and these days specialized pharmacies still produce made-to-order medicines prescribed by doctors.

The FDA can crack down on compounding pharmacists when there's trouble, as it did a few years ago over custom-made hormone therapies for symptoms of menopause. But generally, the agency gives pharmacists a wide berth.

Today, the agency says it's aware that KV has been telling pharmacists FDA "will no longer exercise enforcement discretion with regard to compounded versions of Makena." (Read one of the letters online here.) To which the FDA responded, bluntly, "This is not correct."

In fact, the agency went out of its way to encourage pharmacists to get into the game, as long as they can produce the Makena substitute properly:

In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion.

So the heat is on KV. I contacted a company spokeswoman for a comment, which wasn't immediately available.

Update: KV's Ther-Rx unit issued a statement this afternoon, saying, in part, that it "takes very seriously the public concerns raised regarding the list price of Makena." The company said it's committed to making sure the medicine is available "at an affordable cost and to all women" who get prescriptions for it. "We are finalizing solutions to the concerns, and will announce them by the end of the week."

Bonus video: For more on the history of compounding and how it works today, check out the FDA video below.