The outrage: Recently KV Pharmaceuticals was granted exclusive manufacturing rights for an orphan drug previously known as 17 P (the P is for progesterone - a hormone similar to what women make naturally) to be marketed as Makena now that it has gained FDA approval. In the past, this important, injectable drug was available only from compounding pharmacies who supplied this to physicians for their patients at a cost of $10-$15 per injection. Women who have previously delivered a single preterm baby (not twins) could benefit from taking this drug weekly beginning 16-20 weeks and continuing through week 36 of gestation. Read a summary here. KV pharmacy has priced the drug at $1,500 per injection (a 100 times cost). They claim they have costs associated with this but in truth, testing has already been done and this is a lie. It is gouging of a vulnerable population. They're doing it because they can. They have also sent letter to compounding pharmacies stating that legal action would be taken against them if they continue to supply this drug. This action would come from the FDA. Public outcry (including physicians) has resulted in a statement by the FDA saying:
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, it has backfired. The FDA can see that this is an outrage and while not actually saying it, the refusal to take enforcement action against the actually affordable competition says a lot. Compounding pharmacies have gone to much trouble and expense to be able to provide this and to have it ripped away only to be "provided" at an exaggerated cost is legalized robbery by BigPharm. I can only congratulate the FDA for making this statement.
Erin R. Fox, Pharm D at U of U Pharmacy which compounds has stated in response. "For now, we probably want to continue to compound as before." (This means women can continue to get this drug here in Utah without the price gouging)
Sherod Brown, Senator from Ohio said about Makena,
See also ACOG
"This is a personal story for me. My doctor sent me to a high risk doctor because of my history or pre-term birth and "advanced maternal age." The high-risk doctor wants me on this drug, and we told her no due to the cost. We can pay for his college education instead for $30,000."