Premature birth-preventing drug faces cost spike
March 9, 2011 11:47 PM Subscribe
posted by disillusioned (63 comments total)
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injections have been used to reduce the likelihood of premature births in at-risk pregnant women for years. Up until now, the drug was custom-compounded by wholesale and specialist pharmacies, legally, but without federal approval. These injections cost between $5 and $15 a dose and were regularly reimbursed by insurance companies and Medicaid.
Last month, the FDA announced their approval
of a commercially produced version of the compound, to be marketed under the brand name Makena by a company called KV Pharmaceuticals.
No stranger to controversy and trouble, KV barely survived a rash round of layoffs and wrongful termination lawsuits
. Their former chief executive now faces criminal charges
surrounding the company's failure to notify the FDA that they were producing oversized morphine tablets. (He could also do for a shave, it appears.)
Now, KV has announced that the new drug will be available at a cost of $1,500 per dose
, bringing the total pregnancy term cost of treatment to $25,000-$30,000
, from its former cost of $250-$300, a 100-fold increase
—but it gets worse...
The FDA granted Makena ophan drug status
, allowing them exclusive rights to produce the compound. As such, KV has sent letters to pharmacies manufacturing the non-commercial compound warning them to stop or face FDA action.
In what can only be characterized as a bit of cognitive dissonance, new KV Pharmaceutical chief Gregory J. Divis Jr "said the cost is justified to avoid the estimated $50,000 cost of mental and physical disabilities that can come with very premature births."
"Makena can help offset some of those costs. These moms deserve the opportunity to have the benefits of an FDA-approved Makena."