1. Short title This Act may be cited as the Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act . 2. Accelerated approval of certain drugs that are authorized to be lawfully marketed in other countries Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 506 the following: 506–1. Accelerated approval of certain drugs that are authorized to be lawfully marketed in other countries (a) In general The Secretary may approve an application for approval for a drug under subsection (c) or (j) of section 505 that is currently authorized to be marketed in one or more of the countries included in the list under section 802(b)(1), upon a determination by the Secretary that the sponsor has submitted evidence sufficient to demonstrate all of the criteria under subsection (b)(1). (b) Criteria (1) In general The Secretary may approve a drug under subsection (a) only if the Secretary determines that there is evidence that— (A) at the time of application, the drug is authorized to be marketed in a country included in the list under section 802(b)(1); (B) the drug is safe and clinically effective and has a satisfactory history of clinical trials and data; (C) the manufacturer is capable of manufacturing the drug safely and consistently, and can assure the safety of the supply chain outside the United States; (D) all relevant United States patents or legal exclusivities are expired; (E) absent reciprocal marketing approval, the drug is not approved for marketing in the United States; (F) the Secretary has not, because of any concern relating to safety or effectiveness, rescinded or withdrawn any such approval