; and (4) by adding at the end the following: (m) Separate REMS When used in this section, the terms different, comparable aspect of the elements to assure safe use or different, comparable approved risk evaluation and mitigation strategies means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 505(j) that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 505(j) with the same such listed drug, but achieves the same level of safety as such strategy. . II INCREASING ACCESS TO DRUGS AND BIOSIMILAR PRODUCTS 201. Expedited development and priority review for generic complex drug products Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by adding at the end the following: 524B. Expedited development and priority review for generic complex drug products (a) Establishment of program The Secretary shall establish a program to expedite the development of, and provide priority review under section 505(j) for, generic complex drug products. (b) Request for designation A sponsor of a generic complex drug product may request that the Secretary designate such product for expedited development and priority review under this section. (c) Designation process (1) In general Not later than 60 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the product that is the subject of the request meets the criteria under subsection (e) to be considered a generic complex drug product. If the Secretary determines that the product meets the criteria, the Secretary shall designate the product for expedited development and priority review. (2) Review Review of a request under subsection (b) shall be undertaken by a team that is composed of experienced staff and senior managers of the Food and Drug Administration. (3) Withdrawal The Secretary may not withdraw a designation