FDA Issues Policy on Orphan Drug Exclusivity Due to Court Decision

In response to a recent district court decision, Food and Drug Administration Dec. 23 published a policy statement to clarify its position on orphan drug exclusivity (79 Fed. Reg. 76888).

In the policy statement, the FDA said that a sponsor of a designated drug that is the same as a previously approved drug must demonstrate that its drug is clinically superior to the previously approved drug upon approval in order for the drug to be eligible for orphan drug exclusivity.

The Orphan Drug Act, enacted in 1983, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to promote and ...