K V hired a corporate intelligence firm to obtain and test samples of the compounded version, 17P, for potency and purity.
Fourteen-year-old Jess, the first pupil we met in the opening episode last night of the three-part documentary, seemed to be very much the compounded version – possibly with a little gelignite thrown in for extra volatility.
When the F.D.A. was given the data last fall, the agency decided to take its own samples of the compounded version, prompting the International Academy of Compounding Pharmacists, the trade organization, to offer its members advice on how to respond to F.D.A. requests, in an e-mailed member alert titled, "F.D.A. Calling Compounders about 17-P".
Other investors in the round include Lux Capital, Digital Currency Group, Compound, Version One, Kal Vepuri, Rising Tide, and earlier investor Naval Ravikant of AngelList.
KV then stuck out its scorpion tail and announced it would charge $1,500 per dose for the drug, a 15,000percentt markup over the $10 going rate for the compounded version, and mailed a letter to all of the compounding pharmacies threatening them with legal action if they continued making the compounded version of the drug.
The compounded version of Makena cost between $10 and $20 per injection, but Makena's manufacturer, KV Pharmaceuticals, was supposed to have exclusivity under the Orphan Drug Act for seven years.
Furthermore, he said it is rare for anyone to verify whether a patient really needs a compounded drug and isn't being given the prescription simply because the compounded version is cheaper.
In the end, the FDA continued to allow compounding pharmacies to produce the active ingredient in Makena, hydroxyprogesterone caproate, because the compounded version predated the Makena brand name and an FDA analysis of compounded samples didn't yield major safety concerns.
In addition, Medicare and many private insurers reimburse a fixed amount for the injections, about $300, giving doctors a financial incentive to prefer the less costly compounded versions, he said.
She takes in all that Touchstone feels and knows and, with a lightning celerity -- Rosalind is one of Shakespeare's quickest-thinking characters -- begins compounding a version of erotic love that includes sexual desires but isn't bounded and defined by them.
