KV Pharmaceuticals may be vindicated with respect to one of its arguments with the FDA -- that being compounders do NOT offer the same level of manufacturing control as a validated GMP process.
I've been openly critical of KV in its introduction of Makena -- but most, if not all, of the criticsim has been aimed at its marketing/business decisions. If you rememeber, Makena is essentially a GMP version of a compounded product -- a synthetic progesterone -- that had been commonly used to treat some high risk preganancies. Under the Orphan Drug Act provisions, KV made a licensed version of the product and called it Makena.
So far so good? Company recognizes a market need and takes advantage of Orphan Drug Act to produce a more controlled version of the product. So what's the problem? Due to its inherently shaky finances, the company decided to hike the price from $20 per dose to over $1500! The resultant hue and outcry from doctors, insurers, congressman, etc essentially sunk the product before it even started. Rightfully, so in my view.
On top of this background though, the FDA made the unusual decision to not "go after" pharmacies who continued to supply the compounded product. That's unusual when there is a licensed version of the product for sale -- which normally the FDA would support the use of. More in keeping with its QbD and other quality enhancng initiatives.
KV finally reacted (with its back against the wall and few other options) by suing the FDA for allowing compounders to continue to operate. The FDA has maintained that they haven't seen any proven problems with compounders of a Makena type product. And that is true -- so far.
However, the recent problem with fungal meningitis being spread by a compounded steroid product highlights the potential safety issues that can come with compounding -- where GMP type controls are lessened. This would seem to me to at least bolster KV's legal argument that FDA is erring in not treating the licensed Makena as a superior quality product --- regardless of its unsavory pricing. Normally, the FDA is charged with safety and efficacy and not economics -- which should be left to other policy makers like insurers or elected government.
Posted by Bruce Lehr Oct 9th 2012.