KV Pharmaceutical genitourinary news

KV filed a suit in the U.S. District Court for the District of Columbia alleging that FDA's statements and policy on compounded hydroxyprogesterone caproate products violated KV's right to market exclusivity for preterm birth drug Makena hydroxyprogesterone caproate under the Orphan Drug Act of the Food, Drug and Cosmetic Act. KV also disclosed in the complaint that it will exhaust its capital in three to six months and will need to file for bankruptcy unless FDA publically signals that it will stop the "unlawful competition" by compounded products. At March 31, the company had $50.7 million in cash.

KV argues that FDA's statements and policy of non-enforcement gave de facto approval to compounded products, which have been used as a cheaper alternative to Makena, and therefore "effectively nullified" KV's seven-year exclusivity. Last March, the agency said in a statement that it is exercising discretion to allow compounding "to support access to this important drug, at this time and under this unique situation." The company argues that FDA has no authority to consider cost in determining whether there is sufficient access to an Orphan drug and that the agency made no determination that patients have insufficient access to Makena. KV is seeking an order that FDA withdraw its previous statements, issue a new statement declaring that compounded hydroxyprogesterone caproate products are illegal and take "sufficient enforcement actions" to stop their distribution, including preventing the importation of APIs for the compounded products. FDA must file an answer by July 20 and a motions hearing is scheduled for Aug. 7. ...