Dr. Weeks’ Comment: Big Pharma charges big fees because (as they tell it) because their research costs are so high. Sounds reasonable. But let’s consider the research cost incurred by KV Pharmaceutical in “sponsoring” a natural product which was first used in 1956. Their research cost: approximately ZERO. (Their marketing costs are unknown.) Cost to patients for a natural product (“drug”) that was selling for $15/dose when last available from compounding pharmacies: $1,500/dose!
(Yes, dear reader, you are NOT reading a typo; the mark up is 100 fold, not 100%.)
Read on. The ending is happy, although FDA and Big Pharma has well-deserved egg on their faces.
Thanks to Dr. Saul for this info: Source:
The natural compound molecule hydroxyprogesterone: 17OHPC was first introduced in 1956 as Delalutin to reduce pregnancy loss.
After decades of use, Squibb, the manufacturer, voluntarily withdrew the brand, however, physicians continued to use 17OHPC “off label”.
Renewed interest was sparked with a large NIH-sponsored study in 2003 that found that 17OHPC reduced the risk of premature birth in selected at-risk pregnant women. With follow-up data showing no evidence of harmful effects on the offspring, the FDA approved the drug, as sponsored by KV Pharmaceutical as Makena, as an orphan drug in February 2011 to reduce the risk of premature birth in women prior to 37 weeks gestation with a single fetus who had at least one previous premature birth. The drug is not effective in preventing premature birth in women with multiples.
With the arrival of Makena as an orphan drug, the price of the drug was to increase from $15 to $1,500 per dose meaning a typical treatment would cost $25-30,000, – a pricing strategy that was strongly criticized.
The FDA then announced that pharmacies could continue to compound the drug at their usual cost of $10~20 per dose without fear of legal reprisals, and KV reduced its price to $690 per dose.
However the FDA is also trying to shut down compounding pharmacies…. stay tuned!
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