I picked on KV Pharma a lot for its handling of the Makena product introduction a coupel years ago -- particularly for its greedy pricing decisions. The decision was basically so egregious that it caused the FDA to continue to allow compounders to compete with Makena -- even though they were now making non-approved formulations of an approved drug.
KV ultimately was forced to file for bankruptcy as a result. And I thought that would be the end of them. Yes, they sued FDA for allwoing this situation. Not unpredictably, they lost that too. I thought -- aha -- their last gasp and goodbye.
Not so fast. The New England Compounding Center, through its scandalous distribution of contaminated product leading to a national meningitis outbreak, single-handedly revived KV's and Makena's fortunes. They validated any concerns that KV was promoting that "compounders" are dangerous when supplying at a geographical diverse scale (and one clearly beyond their charter). What's more? Additional compounders managed to further bolster the case.
Now KV may be making a comeback (again). It's Alive! They are back promoting Makena and saw scripts rise from 2000 per quarter last year to more than 8419 in the last quarter. Zounds! It took rotten performance by compounders to bolster the KV case on safety. But those pesky compounders pulled it off. See Pharmalot.
Posted by Bruce Lehr June 3rd 2013.