1. Short title This Act may be cited as the Ensuring Access to Lifesaving Drugs Act of 2023 . 2. Extended expiration dates for life-saving drugs (a) In general The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) is amended by inserting after section 506L of such Act ( 21 U.S.C. 356l ) the following new section: 506M. Extended expiration dates for life-saving drugs (a) In general A manufacturer of a life-saving drug shall— (1) submit to the Secretary data and information as required by subsection (b)(1); (2) conduct and submit the results, data, and information generated by any studies required under subsection (b)(2); and (3) make any labeling change described in subsection (c) by the date specified by the Secretary pursuant to such subsection. (b) Data and information (1) In general The Secretary may issue an order requiring the manufacturer of a life-saving drug to submit, in such manner as the Secretary may prescribe, data and information from any stage of development of the drug that are adequate to assess the stability of the drug to determine the longest supported expiration date. (2) Lack of data and information If the data and information required pursuant to an order issued under paragraph (1) are not available or are insufficient, as determined by the Secretary, the Secretary may issue an order requiring the manufacturer of the drug— (A) to conduct studies, which may be a continuation of ongoing studies, to provide data and information adequate to assess the stability of the drug and to determine the longest supported expiration date