The Orphan Drug Act: How the FDA Unlawfully Usurped Market Exclusivity

Kim, Sumin | August 1, 2013

The Board of KV Pharmaceutical bet the company on the success of Makena®, a pre-term birth drug. However, in the midst of a public outcry over the excessive pricing of Makena®, the FDA declared that it would not honor the market exclusivity that KV Pharmaceutical had obtained for Makena® under the Orphan Drug Act. As a result, KV Pharmaceutical filed for Chapter 11 bankruptcy. This Note analyzes the situation under the lens of the Takings Clause of the Fifth Amendment. Specifically, I argue that market exclusivity for Makena® was private property and thus, the FDA unlawfully usurped KV Pharmaceutical’s private property without just compensation.