The FDA Has Announced That It Will Allow Compounding Pharmacies To Continue To Mix Generic Versions Of The Now-Approved Drug Makena Without Consequence.
The FDA has announced that it will allow compounding pharmacies to continue to mix generic versions of the now-approved drug Makena without consequence.
Remember when the FDA approved Makena - the now brand name drug used to prevent preterm births? You might also recall how we then learned - following this great news - that Makena was going to cost $1,500 per dose, meaning women who needed it would face up to $30,000 worth of injections for a single pregnancy. The previously generic drug that was mixed at compounding pharmacies cost $10-$20 per injection. After KV Pharmaceutical won FDA approval, it was revealed that the cost would skyrocket to $1,500 per injection, representing a 15,000% increase. Doctors, groups representing preterm babies and their mothers, and expectant moms all reacted with outrage. Makena - and its previously generic version - is a drug that can truly help prevent preterm birth. On Wednesday, the FDA did something rather unusual. It announced that compounding pharmacies would still be allowed to mix the generic version of Makena without consequence, so long as their mix was safe. It sounds like KV Pharmaceutical's previous cease and desist letters that it sent to compounding pharmacies aren't so threatening now.
On Wednesday, the FDA challenged KV’s warning to specialty pharmacies that had been producing the cheaper versions of the drug that the agency would no longer permit that. “This is not correct,” FDA spokeswoman Beth Martino said in an e-mailed statement that was later posted on the agency’s Web site. Although the agency usually does not recommend patients use compounded versions of FDA-approved drugs, “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” the agent, the statement said. The agency will only step in if “the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products,” according to the statement. “As always, FDA may at any time revisit a decision to exercise enforcement discretion.” (Source: The Washington Post)I was extremely happy to read this. I also wonder whether the FDA powers-that-be wonder if they made a mistake approving Makena in the first place. It's not exactly typical for the FDA to directly state that they won't take any action against pharmacies who mix drugs on their own that are patented, so long as their individual mixes are safe. KV Pharmaceuitcal's stock feel 20% after the announcement, and while that's extremely unfortunate from a business standpoint, the fact that women will still have access to a drug that can literally save their babies' lives -- a drug that they already had access to before a pharma company reformulated it and raised the price by 15,000% -- is what matters to me.