1. Short title This Act may be cited as the Accelerated Drug Approval for Prescription Therapies 2.0 Act or the ADAPT 2.0 Act . 2. Drugs approved in certain foreign countries (a) In general Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended— (1) in subsection (b), by adding at the end the following: (7) An application described in paragraph (2) may rely upon investigations conducted in a country listed under section 802(b)(1)(A) or designated under section 802(b)(1)(B), including premarket clinical and nonclinical investigations and postmarket surveillance studies, if the drug that is the subject of such application has been approved in such country. ; and (2) in subsection (c)— (A) in paragraph (1), by striking Within and inserting Except as provided in paragraph (6), within ; and (B) by adding at the end the following: (6) (A) In the case of an application that relies on investigations conducted in a foreign country, as described in subsection (b)(7), within 90 days after the filing of such application under subsection (b), the Secretary shall approve the application if the Secretary determines evidence that— (i) at the time of application, the drug is authorized to be marketed in a country listed under section 802(b)(1)(A) or designated under section 802(b)(1)(B); (ii) the drug is safe and clinically effective; (iii) the manufacturer is capable of manufacturing the drug safely and consistently, and can ensure the safety of the supply chain outside the United States; (iv) all relevant United States patents or legal periods of exclusivity are expired; (v) absent reciprocal marketing approval, the drug is not approved for marketing in the United States; (vi) the Secretary has not, because of any concern relating to safety or effectiveness, rescinded or withdrawn any such approval