“To protect against premature births and miscarriages in women who don’t secrete enough progesterone, doctors have for decades prescribed progesterone medications that were made by state-licensed compounding pharmacies. The cost per injection was around $20.
By granting orphan drug status to one company (KV Pharmaceutical), FDA rules banned all other forms of progesterone for this indication. The immediate impact was that the cost per injection of this progesterone drug was set to skyrocket to $1,500-or as much as $30,000 for a full-term pregnancy.
An uprising over this price gouging forced the FDA to back down and state it “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate.
What the FDA is saying is that while it has the discretion to arrest compounding pharmacists for making this drug, it does not “intend to” do so. After FDA made this announcement, KV Pharmaceutical reduced the price to $690 per injection” This is from William Faloon’s book “Pharmocracy”, p.13
KVP did not incur any recent development or testing expenses for Makena, the brand name, The drug was developed by another company in the 1950’s. It has been used successfully since then. It is also now known as 17P generic. Compounding pharmacies can custom make the drug to suit individual needs.
KVP alleged that the generic is made in China and may be improperly mixed at the compounding pharmacies. There was no proof of any health hazards actually occurring. In spite of this, the FDA granted an “orphan drug” monopoly for seven years.
It is not hard imagine the impact this price gouging would have on people with no insurance or high deductible insurance. When insurance pays for this, then we pay for it in higher premiums and deductibles.
In August, 2012, KVP filled suit to force the Illinois state Medicaid to pay the $300 per injection at a discount from the $530 standard Medicaid price. Other lawsuits have been filed to promote this monopoly pricing on the $15-20 drug. So the fight goes on.
When will Americans demand that their representatives change these monopoly laws that are used to soak individual citizens and insurances? Campaign contributions and lobbyists are keeping these monopolies intact.
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