The recent uproar over KV Pharmaceutical’s pricing of Makena, 17 alpha-hydoxyprogesterone caproate or 17OP for preterm labor, has left many wondering if Makena (and it’s $1,500 per shot/$30k per pregnancy price tage) can simply be avoided and pregnant women continue to get 17OP from compounding pharmacies (at the very reasonable $10 or so a shot).
The answer is yes. Compounding pharamcies are STILL an option.
Even though KV Pharamceuticals has sent warning letters to compounding pharmacies, in reality there is nothing they can do about any pharmacy who continues to compound 17OP. That is because KV doesn’t have a patent on the actual hormone itself. What they have is orphan drug status, which gives them the right to exclusively manufacturer and market the product for seven years. They may patent their specific formulation, but compounding pharamcies have their own recipes.
Compounding pharmacies each having their own recipe was the supposed reason the March of Dimes jumped on board the Makena bandwagon. In theory, it is better to have a drug made uniformly with standardized testing for purity, potency, etc. For example, if 17OP were less effective for women in one part of the country, without a uniformly manufactured drug it would be hard to know if the problem were patient demogrpahics, other issues related to medical care, or the fact that the 17OP all came from one compounding pharmacy that maybe wasn’t as good as another pharmacy down the road.
Although that being said, there have been no reports of compounding issues/lack of efficacy with compounded 17OP. None.
The law says a compounding pharamcy can mix up any FDA approved/legal drug or hormone. Since compounding 17OP is not patent infringement, KV Pharamceuticals is poweless to do anything. Having ophan drug status doesn’t help much either, because the compounding pharamcies are not marketing the drug, they are filling a physician’s prescription. They are also not manufacturing it, they are filling prescriptions one or two at a time.
The ONLY way KV Pharamceuticals can stop the compounding of 17OP is to go to after the source manufacturers of the bulk 17OP powder and convince them to stop selling to compounding pharmacies. There are several companies that make 17OP bulk powder, so that scenario is unlikely to unfold.
The only one who can actually stop the compounding pharmacies is the FDA. Considering all the pharmacies that already compund tons of hormones, some with nebulous indications and even potentially dangerous side effects (testosterone and your 1% risk of breast cancer a year for women, I’m looking squarely at you), there is no way the FDA can go after pharamcies for mixing up a drug that has been proven to be effective and recommended by the American Congress of OB/GYN.
So to the pharmacies I say, “Compound away!”
And as my friend Dr. Nicholas Fogelson suggests, OB/GYNs should boycott KV Pharamceuticals and Makena and keep supportng their local compounding pharamacies.
KV Pharmaceuticals should not be allowed to line their coporate coffers (to the tune of $4 billion/yr) at the expense of premature babies.
Just say no to Makena. We have the power to stop this.