Bill > S1421

This bill, the Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015, amends the Federal Food, Drug, and Cosmetic Act to grant a six-month extension to a drug's or biological product's exclusivity period if it receives approval from the Food and Drug Administration (FDA) for a new use that treats, diagnoses, or prevents a rare disease or condition, also known as an "orphan disease." The Department of Health and Human Services (HHS) is responsible for designating these drugs and can revoke the extension if the application for the new indication contained false material information. Drug sponsors receiving this extension must notify HHS one year before discontinuing production for commercial reasons, and HHS will publicly announce which products receive these extensions and their associated patents. Importantly, a product can only receive this extension once, and it is in addition to any other existing exclusivity extensions, such as those for pediatric use or for treating infectious diseases. This provision applies only to drugs approved for a new rare disease indication after the bill's enactment.