Both The March of Dimes and The American Congress of OB/GYN (and apparently a few other medical professional societies) supported KV Pharmaceuticals application to the FDA to be the sole manufacturer of 17 Alpha Hydroxyprogesterone caproate (17P), the hormone that can help reduce the risk of delivering prematurely for a woman with a previous preterm delivery. These woefully out of touch organizations were clearly blindsided when the price hike from $10 to $1,500 per shot was announced (even though those who follow the industry expected this price point).
The reason KV Pharmaceuticals bid was supported by The March of Dimes et. al. was “issues” with compounding 17P. I am assuming this means quality/stability/purity; however, I have yet to see any published data supporting this assertion. These issues were also not mentioned when I attended a high-righ pregnancy conference sponsored by ACOG in 2010, even though there was a lot of discussion about progesterone for prevention of prematurity. I find that fact oddly curious.
If quality issues with compounding 17P are indeed true (and not just innuendo, because the FDA really does have a vendetta against compounding pharmacies) why not simply standardize the process? Labs have to do this – you want to run lab tests, your facility must be CLIA certified. So, the obvious answer would have been for the NIH to sponsor a symposium (taught by pharmacists from an academic institution who have experience compounding) to establish specific standards for making 17P. Those pharmacists who attend and the follow some kind of once every 2 or 3 year re-certification process would be 17P certified. Insurance companies could say they will only pay for 17P to be compounded by a certified pharmacy. If the pharmacists roll the price of this kind of certification into the product, it might raise the price a bit, maybe to $30 a shot.
This way everyone would win. There would be a specific, standardized protocol for compounding so both patients and insurance companies could avoid the potential hazards of improperly compounded progesterone. And it wouldn’t cost $30,000 a pregnancy.
It seems that the FDA, the March of Dimes, ACOG and anyone else who supported KV Pharmaceuticals bid is lacking in both business sense and common sense.