This is the key question currently pending in the D.C. District Court.

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

List Price of Makena® at Issue

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After the original commercial version of the drug (Delalutin®) was withdrawn in 1999, 17-HPC was available in the U.S. only through compounding pharmacies.
However, in 2011, the 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 the 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 the FDA.

FDA Declares its Enforcement Intent

On March 30, 2011, the 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.

KV Suit Challenges FDA Decision and Identifies Risks

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.”

FDA Argues Enforcement Decisions Are Within Its Discretion and Denies Risks

In its opposition, the FDA argued that its statement is not subject to judicial review because the FDA’s decisions not to take enforcement action are within its discretion.

The FDA also contends its statement does not state a violation of the FDCA.

Finally, the FDA challenges KV’s safety arguments concerning compounded 17-HPC. According to the FDA’s brief, its testing of compounded drug samples and of the active ingredient did not demonstrate any major safety concerns.

The 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 Crucial for KV

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.

This article was prepared by Saul Perloff ( / 210 270 7166) and Bob Rouder ( / 512 536 2491) from Fulbright’s False Advertising Practice.