This means that FDA generally “will not approve another sponsor’s marketing application for the same drug for the same use or indication before the expiration of 7 years.” 21 C.F.R. § 316.31(a). These changes to the predecessor drug required Ipsen to obtain new approval from FDA under both the FDCA and its implementing regulations.

Indeed, FDA’s position is inconsistent with the thrust of its own unlawful regulatory structure, which explicitly contemplates orphan drug exclusivity for already treated patients. 21 C.F.R. § 316.31(a) (allowing exclusivity for clinically superior orphan drugs to treat the same orphan disease or condition as the previously approved drug). FDA’s Letter Ruling makes vague references to the Act’s legislative history, FDA0033, but FDA does not and cannot cite any such history that actually supports its position that exclusivity was intended to be limited to the first drug to treat a patient population.