Are orphan drugs exempt from FDA User Fees?
A human drug application for a prescription drug product that has been designated as a drug for a rare disease or condition pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act, shall not be subject to a fee unless the human drug application includes an indication for other than a rare disease or condition.A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee, if the drug has been designated pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act as a drug for a rare disease or condition with regard to the indication proposed in such supplement.There is no specific exemption for orphan drug products from annual product and establishment fees. However, sponsors of orphan drugs can request a waiver, under section 736(d)(1) of the Federal Food, Drug, and Cosmetic Act.
