KV Pharma in an apparent act of desperation has filed suit against the FDA to compel the agency to take action against compounders of KV's approved drug, Makena. If you remember, KV raised a howl last year when Makena was approved by FDA and then proceeded to use its market exclusivity as a lever to raise prices on Makena from $10 (for the similar compounded drug) to $1500 per dose. OUCH!
As a result of the ensuing brouhaha from patients, their advocates and payers, the FDA refused to stop compounders from making their unapproved versions of Makena unless there was a know problem. This leaves KV with lots of price competition and not much they can do to stop it. So they sued! It's only a matter of time before they go out of business though.
I will comment that it is tough for the FDA to justify its current stance relative to safety on this one. Normally, they would prevent compounders from operating when an approved alternative was available. Unfortunately, they happened to approve KV who abuse their trust by pricing its product at astronomical levels to try to repay investors quick. Oops! Must have been absent during Marketing 101 as well as failed to heed government concerns about cost control in health care.
Live by the gouge, die by the gouge I always say.
Posted by Bruce Lehr Jul 9th 2012.