We have followed the saga of KV’s Makena for two reasons. The most important reason is that the submission, review and approval of Makena is perhaps the best example of using a publicly funded clinical study for NDA approval, despite the clinical trial material not being sourced by the sponsor of the NDA. The other reason is that makers of unapproved products need the incentive of market exclusivity to justify the costs to conduct the studies and pay the fees to gain NDA approval. In the case of Makena, FDA actually seemed to further the interests of the compounding pharmacists to the detriment of KV’s market. In a press release, FDA supported the continued availability of the compounded drug product. KV sued to have the FDA retract that statement and stop the import of API that it said did not meet its NDA API specifications. The court refused to intervene based on the theory that FDA’s decisions and statements were unreviewable and that KV lacked standing. The court stated that FDA has the power to not enforce its regulations.
On March 11, KV appealed, arguing that the FDA actions are reviewable and that KV has standing. Essentialy, KV says the previous ruling was in error. In part, KV states that FDA was not just not enforcing its regulations but that it was actively soliciting unlawful conduct.
We will continue to follow.