Sunday, April 03, 2011

KV Pharma's Makena ( 17P )

The litigationandtrial blog gives some background on the Makena (17P) mess. One sees that patent rights on the composition had long expired and that an off-label use was involved.

Various medical researchers suspected that 17P treatment could be used to prevent preterm labor, and so in 2003 the National Institutes of Health — which, as a reminder, is a government entity funded by taxpayers — financed a study into using 17P for that purpose. It worked.

Ever since then, a number of health insurance companies have covered "off-label" use of the drug by expectant mothers to prevent preterm labor, because the modest cost of administering an old drug outside of its patent was but a tiny fraction of the potential cost of premature birth followed by weeks or months in the NICU (which, as an intensive care facility, isn't cheap), years in developmental therapy, and potentially a lifetime of support services for cerebral palsy or other neurological or cognitive conditions.

17P is 17 alpha hydroxyprogesterone caproate and goes back to the 1950s.

Of the most recent twist, from ABCNews:

But a recent move by the FDA could open a low-cost way to obtain the progesterone shot.

Under FDA exclusivity rules, production of the cheaper version of the drug by specialty compounding pharmacies would ordinarily have to cease. Following the public outcry over KV's pricing, however, the FDA announced Wednesday that it had no intention of enforcing its own rules, reopening the doors for women to continue to obtain an affordable version of the drug, known clinically as 17P

KV had sent cease-and-desist letters to compounding pharmacies regarding 17P in error, the FDA said Wednesday, saying it would only step in to halt production when the safety of the product was in question.

The FDA granted KV approval to produce this already-in-use drug in February, a move many maternity experts hoped would offer a more regulated and readily available version of the shot. When KV announced it would charge about hundred times what patients were paying at compounding pharmacies, a firestorm of criticism ensued, and the pharmaceutical company has backpedaled on its pricing.

As to --more regulated and readily available version of the shot --, the best laid plans can lead to unexpected consequences.


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