By Kurt R. Karst – In a rare lawsuit against FDA involving the Orphan Drug Act of 1983, as amended, K-V Pharmaceutical Company (“KV”) and its wholly-owned subsidiary, Ther-Rx Corporation (“Ther-Rx”), filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the U.S. District Court for the District of Columbia last week. The Plaintiffs are seeking temporary, preliminary, and permanent declaratory and injunctive relief to “restore” Plaintiffs’ orphan drug exclusivity for MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL. FDA approved MAKENA on February 3, 2011 under NDA No. 021945 “to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.” Because FDA had previously designated MAKENA (formerly known as GESTIVA) as an orphan drug for the approved indication, the Agency granted KV a period of 7-year orphan drug exclusivity that expires on February 3, 2018. (On the same day that FDA approved MAKENA, the Agency denied a Citizen Petition – Docket No. FDA-2007-P-0051 – requesting that FDA revoke the orphan drug designation.) Orphan drug exclusivity prevents FDA from approving another company’s version of the “same drug” for the same disease or condition for 7 years, unless the subsequent drug is different from the approved orphan drug, or because the sponsor of the first approved product either cannot assure the availability of sufficient quantities of the drug or consents to the approval of other applications. For several years, hydroxyprogesterone caproate injection, also known as “17p,” has been made available to women at risk of preterm birth by compounding pharmacies that compound the drug. In some cases, product is reportedly imported into the U.S. FDA’s policy (see Compliance Policy Guide 460.200), issued in the wake of the U.S. Supreme Court’s April 2002 decision in Thompson v. Western States Medical Center, 535 U.S. 357 (2002) striking down as unconstitutional certain provisions of FDC Act § 503A concerning pharmacy compounding, is generally not to permit pharmacy compounding of drugs that are commercially available and approved by FDA. Nevertheless, in a move that stunned many (including us – see here and here), FDA issued a press release on March 30, 2011 stating, in relevant part, that “[i]n order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate 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.” Within hours of FDA issuing its press release (referred to by Plaintiffs as the “Statement”), the Centers for Medicare & Medicaid Services (“CMS”) issued its own statement informing States and Medicaid payers that they “can choose to pay for the extemporaneously compounded hydroxyprogesterone caproate” notwithstanding the availability of MAKENA. The FDA and CMS statements followed some controversy concerning the price of MAKENA that sparked interest from some members of Congress. FDA issued further public statements on MAKENA on November 8, 2011 and June 15, 2012 (here and here), and CMS issued an updated statement on June 15, 2012 in light of some analyses conducted on compounded 17p. FDA also issued a “Questions and Answers” document on June 29, 2012 discussing the Agency’s risk-based approach to enforcement action against compounding pharmacies and with respect to compounded 17p. Plaintiffs allege in their Complaint, however, that “[n]one of these statements has announced an intent to take enforcement action against unlawful compounded 17P that is not customized to meet the special needs of individual patients who have the condition for which Makena, a drug that ha read more..