§ 360cc

((a)) ** Exclusive approval, certification, or license** Except as provided in subsection (b), if the Secretary— ((1)) approves an application filed pursuant to , or ((2)) issues a license under ((b)) ** Exceptions** During the 7-year period described in subsection (a) for an approved application under or license under , the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if— ((1)) the Secretary finds, after providing the holder of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or ((2)) the holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period. ((c)) ** Condition of clinical superiority** ((1)) ** In general** If a sponsor of a drug that is designated under and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug.section 360bb of this title ((2)) ** Definition** For purposes of paragraph (1), the term “clinically superior” with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care. ((3)) ** Applicability** This subsection applies to any drug designated under for which an application was approved under or licensed under after , regardless of the date on which such drug was designated under .section 360bb of this titlesection 355 of this titlesection 262 of title 42section 360bb of this titleAugust 18, 20172017-08-18 ((d)) ** Regulations** The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on , until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act.August 18, 20172017-08-18 ((e)) ** Demonstration of clinical superiority standard** To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary— ((1)) upon the designation of any drug under , shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and ((2)) upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.