KV Pharmaceuticals, the St. Louis-based company behind the preterm labor drug Makena, set off a bit of a scare in February by sending a letter to compound pharmacies saying that these pharmacies should stop producing a cheaper alternative of the drug that lacks formal approval from the US Food and Drug Administration (FDA). But yesterday, the FDA announced that it won’t go after these pharmacies so long as the compounded version remains safe and is of good quality.

“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 […] unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards,” the FDA said in a statement.

The decision sent patients’ spirits soaring — and KV Pharmaceuticals’ stock downwards. Makena, approved last month, costs $1,500 per dose, whereas the drug made by the compounding pharmacies, costs just $10 to $20 per dose. It’s a story not too dissimilar from that of Lucentis and Avastin.

In response to yesterday’s announcement, KV Pharmaceuticals says that Makena is the safest option for patients. But it looks as though the company is taking notice of the controversy surrounding its drug pricing: “It is our commitment that every woman who is prescribed Makena will have affordable access to this FDA-approved and FDA-monitored therapy.”

Even though patient advocates may rally around the FDA’s announcement, it’s worth noting that KV Pharmaceuticals’ concerns about the compounded formulation of the drug are not unfounded. Compounding – the process by which drugs are mixed up when existing versions of medicines are unavailable or are insufficient – does not come without risks. According to the FDA, between 1990 and 2005, 240 severe illnesses or deaths were linked to improper compounding. And studies indicate that many of the prescriptions filled at compounding pharmacies are of insufficient potency.

The question then becomes whether or not it is worth these risks to avoid the nearly $30,000 price tag per pregnancy. What are your thoughts? Please share them in our comments section below.

Image: FDA

UPDATE: Pharmalot reports that in response to the outcry over Makena’s cost this week, KV Pharmaceuticals has lowered the price of the drug by 55%.