Drugmaker Sues FDA over Orphan Drug Exclusivity

Jul 18, 2012   

On July 5, 2012, K-V Pharmaceutical Company (“KV“) filed a complaint against the U.S. Food and Drug Administration (“FDA“) in the U.S. District Court for the District of Columbia regarding the right to exclusively market the orphan drug Makena (a hydroxyprogesterone caproate injection). KV is seeking to enforce its statutory right to market exclusivity.

On February 3, 2011, the FDA approved KVs drug Makena “to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.” The FDA also granted KV orphan drug exclusivity that expires on February 3, 2018. Pursuant to section 527 of the Federal Food, Drug, and Cosmetic Act (“FDCA“), orphan drug exclusivity prevents the FDA from approving another companys version of the “same drug” for the same disease or condition for seven 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 more information regarding Makenas FDA approval, please see our previous report.

However, compounded generic versions of Makena, commonly known as 17P, are available at a substantially lower price through compounding pharmacies. Generally, compounded drugs are not reviewed or approved by the FDA because they are made through a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a customized medication for the needs of an individual patient. 17P costs about $10 to $20 per dose at compounding pharmacies, compared to commercially-available Makena which costs about $690 per dose. Thus, many patients are seeking 17P, the unapproved compounded drug, instead of FDA-approved Makena.

In the past, the FDA has generally exercised enforcement discretion against compounding pharmacies operating in conformity with Compliance Policy Guide 460.200. However, despite the statutory market exclusivity for Mekena, on March 30, 2011, the FDA announced it did not intend to take enforcement action against pharmacies that compound 17P unless the compounded products are unsafe. As a way to explain its change in position with regard to compounding pharmacies, the FDA stated that it will not take enforcement action in an effort “to support access to this important drug, at this time and under this unique situation.” Please see our previous report for more information regarding the FDAs enforcement posture for Makena.

In its complaint, KV alleges that the FDA effectively nullified Makenas statutory seven-year period of market exclusivity in violation of section 527 of the FDCA by giving de facto approval to compounded versions of 17P that are intended for use to treat the same indication for which Makena is designated as an orphan drug and is approved. KV is seeking temporary, preliminary, and permanent declaratory and injunctive relief to restore the right to exclusively market the drug Makena.

The purpose of granting orphan drug exclusivity is to incentivize pharmaceutical manufacturers to invest money and resources developing treatments for small patient populations. Without the FDAs enforcement of the seven-year market exclusivity period against compounding pharmacies, manufacturers of orphan drugs have little incentive to develop drug treatments for rare diseases due to high research and development costs. Of course, at $690 per dose, the Makena approval raises the question of whether seven-year market exclusivity will benefit anyone in the first place. The FDAs position vis-a-vis Makena, as well as the upcoming litigation between KV and the FDA will certainly highlight the divide between these two interests.

A Motions Hearing is scheduled for August 7, 2012. Fuerst Ittleman will continue to monitor the developments of the Makena drug case. For more information regarding orphan drugs, compounded products, or for any questions regarding how your company can maintain FDA regulatory compliance, please contact us at contact@fidjlaw.com.