K-V Not Done Fighting for Makena®’s Orphan Drug Rights Over Compounding Pharmacies

gavelgold.jpgK-V Pharmaceutical Company (“K-V”) has taken the fight over its preterm-birth prevention drug, Makena® (17-hydroxypreogesterone caproate solution) (“HPC”), to the International Trade Commission (“ITC”). In its complaint, K-V asks the ITC to: (1) issue a temporary general exclusion order prohibiting any unauthorized importation of HPC and (2) issue a temporary cease and desist order stopping owners, importers, and consignees from importing, selling, offering for sale, distributing, or soliciting any HPC unless authorized by K-V.

K-V states that its merits argument will focus on the importation of HPC for the purpose of making compounded versions of Makena®. K-V argues that importation of HPC for use in compounding copies of Makena® is a violation of Section 337 of the Tariff Act of 1930. According to Section 337, “[u]nfair methods of competition and unfair acts in the importation of articles . . . in the United States, or in the sale of such articles by the owner, importer, or consignee, the threat or effect of which is . . . to destroy or substantially injure an industry in the United States,” are “unlawful.” 19 U.S.C. § 1337(a)(1)(A). K-V argues that, because all HPC in the United States comes from abroad, and the only use for HPC is in the manufacture of Makena® or allegedly unlawful copies of Makena®, the importation of HPC undermines federal law and K-V’s statutory orphan drug exclusivity and “is clearly an unfair act and an unfair method of competition.”

According to the Complaint, all the requisites for temporary relief are present. First, there will be immediate and irreparable harm to K-V because the pharmacies compounding copies of Makena® have diverted so much potential revenue from K-V that the drug company has had to file for Chapter 11 bankruptcy. Second, as mentioned above, there is a likelihood of success on the merits. K-V argues that the importation of HPC for the use in compounding violates the prohibition against mass-scale compounding and undermines K-V’s statutory orphan drug exclusivity. These unfair acts and unfair methods of competition are threatening to destroy K-V, i.e., the domestic industry. Third, K-V argues that the following public interest factors favors granting the desired relief: (1) prevention of preterm births; (2) ensuring safe and effective drugs; (3) preservation of a domestic industry; and (4) effectuating Congress’s intent to promote development of treatments for rare conditions. Finally, K-V states that it faces the balance of hardships. K-V argues that the compounding pharmacies have few, if any, protectable rights, whereas K-V has a “Congressionally-granted seven-year exclusive right to market Makena.” Additionally, K-V notes that its business’s survival depends on the success of Makena®, whereas the proposed respondents compound many other products and will survive if they are unable to compound Makena® during the exclusivity period.

K-V made waves last spring following the approval of Makena® when it listed the drug product at $1,500 per injection. Before the Makena® approval, doctors had prescribed injectable progesterone to prevent preterm birth. As an unapproved drug, pharmacists would compound progesterone injections for between $10 and $20 per injection. Following public outcry over the list price, K-V decided to reduce it from $1,500 to $690. The price of Makena® is another issue that K-V tackles in its complaint to the ITC. K-V defends the high price by discussing the amount of money the company has had to spend to get the drug approved and the amount of money it continues to spend to ensure compliance with FDA regulations. Additionally, because Makena® treats such a rare disease, K-V posits that its list price must be higher than other drugs because of how few patients actually need the drug. K-V also argues that the list price is deceptive, and that most patients do not have to pay the full list price. According to the complaint, for those who have it, insurance covers most of the cost. Additionally, K-V says that it will assist those who have financial difficulties obtaining the product. As such, K-V argues that there will be no supply shortage or public health concerns if their desired relief is granted. Additionally, K-V promises that it will supply HPC to an independent third-party to distribute to any compounding pharmacies for women cannot take Makena® and need a compounded formulation of the drug.

In early September, K-V Pharmaceutical Company (“K-V”) suffered a defeat in its attempt to stop compounding of its orphan-drug Makena® when District of Columbia District Court Judge Amy Berman Jackson found that K-V’s claims against the Food and Drug Administration’s were unreviewable as discretionary FDA enforcement action or failed to state a claim.

K-V’s fight over the compounding of Makena® is not the only story about compounding to come out recently. The recent outbreak of deadly fungal meningitis caused by large scale compounding of steroid injections (as blogged on here) has again raised questions over the safety of compounding, which is not regulated by FDA. In fact, earlier this month, Representative Edward J. Markey (D-Mass) said that he would introduce a bill that would require FDA regulation over any large-scale compounding pharmacies. Additionally, the Massachusetts Board of Pharmacy has issued emergency regulations that will require Massachusetts pharmacies to submit reports twice a year to prove that they are not operating as drug manufacturers. Predictably, K-V dedicates a significant amount of discussion in its complaint to the issues of safety when it comes to the practice of compounding and makes reference to this meningitis outbreak.