For the past several months, KV Pharmaceutical has regularly signaled that its ability to continue as a going concern is jeopardized by its inability to sell sufficient quantities of its Makena medication for premature births. The little drugmaker has been battling with the FDA over a contentious decision by the agency not to pursue compounders unless there is a threat of harm to consumers that may be caused by one of these alternative treatments. Earlier this month, in fact, KV filed a lawsuit against the FDA for failing to prevent some compounding pharmacies from offering lower-cost versions of Makena, which was approved last year under the Orphan Drug Act. But shortly afterwards, both the drugmaker and the FDA came under fire after KV Pharma set pricing at $1,500, compared with $10 to $20 a week for compounded versions of a med that has been used for decades.
