On July 5, 2012, K-V Pharmaceuticals and Ther-Rx ("KV") sued FDA alleging failure to enforce KV's right to market exclusivity for its drug, Makena®. Among other remedies, KV seeks a PI requiring FDA to take "sufficient enforcement actions" to prevent compounding pharmacies from "unlawful[ly] compet[ing]" with Makena®. FDA moved to dismiss KV's suit and responded to KV's PI motion. The Complaint and Response can be found here and here.

The active ingredient in Makena®, 17-HPC, has been used for years to treat women with at-risk pregnancies. After the original commercial version of the drug (Delalutin®) was withdrawn in 1999, 17-HPC was available in the US only through compounding pharmacies. However, in 2011, FDA approved KV's New Drug Application ("NDA") for Makena® and granted Makena® orphan drug status extending exclusivity of the NDA to compensate investments in low-volume drugs that treat rare disease states.

17- HPC/Makena® is administered in a series of injections. KV initially offered Makena® at a list price of about $1,500 per dose while, according to FDA, compounded doses of 17-HPC were available for $10-20 per dose. (KV subsequently reduced the list price to $690 per dose). Makena's® pricing sparked news stories, Congressional interest, and inquiries to FDA.

On March 30, 2011, FDA issued a statement, "[FDA] does not intend to take enforcement action against pharmacies that compound [17-HPC] based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products." Read the full statement.

KV's suit argues that FDA's statement was unprecedented and impermissibly based upon political pressure surrounding pricing rather than upon safety and efficacy issues. KV claims among other things that absent injunctive relief, "Plaintiffs will be effectively deprived of their statutory market exclusivity; and, consequently will be unable to survive as ongoing concerns." Further, KV argues the health and safety of at-risk pregnant women is "subject[] to significant avoidable risks" because, as KV claims, testing has shown that compounded 17-HPC often has "unacceptable potency and/or impurities."

In its opposition, FDA argued that its statement is not subject to judicial review because FDA's decisions not to take enforcement action are within its discretion. FDA also contends its statement does not state a violation of the FDCA. Finally, FDA challenges KV's safety arguments concerning compounded 17-HPC. According to FDA's brief, its testing of compounded drug samples and of the active ingredient did not demonstrate any major safety concerns. FDA argues that "Forcing FDA to reject its enforcement priorities in favor of Plaintiffs' commercial interests would be both inappropriate and contrary to the public interest."

Timing may be a significant factor in this case. According to KV's complaint, unless the company is immediately able to generate "significantly higher market share and revenues from Makena®," it may run out of cash in less than three months.

The case is K-V Pharmaceutical Company and THER-Rx Corp. v. U.S. Food and Drug Administration, et al., case no. 1:12-cv-01105, in the U.S. District Court, District of Columbia.

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