New Taxes for Pharmaceutical and Medical Device Manufacturers/Importers/Distributors : FDA Law Update

Unlike the medical device tax, the new tax on pharmaceuticals is complicated at best, and convoluted at worst. It applies only to "branded prescription drugs", which are defined as any product approved under Section 505(b) of the Federal Food Drug and Cosmetic Act ("FFDCA") that bears an Rx legend required by Section 503(b) of the FFDCA; the only exception is an orphan drug approved only for orphan indications.