Protecting Access to Safe and Effective Medicines Act of 2021

To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity. 1. Short title This Act may be cited as the Protecting Access to Safe and Effective Medicines Act of 2021 2. Clarifying the meaning of new chemical entity Chapter V of the Federal Food, Drug, and Cosmetic Act is amended— (1) in section 505 ( 21 U.S.C. 355 (A) in subsection (c)(3)(E)— (i) in clause (ii), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (ii) in clause (iii), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (B) in subsection (j)(5)(F)— (i) in clause (ii), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (ii) in clause (iii), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (C) in subsection (l)(2)(A)(i), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (D) in subsection (s), in the matter preceding paragraph (1), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (E) in subsection (u)(1), in the matter preceding subparagraph (A)— (i) by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (ii) by striking same active ingredient same active moiety (2) in section 512(c)(2)(F) ( 21 U.S.C. 360b(c)(2)(F) (A) in clause (i), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (B) in clause (ii), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (C) in clause (v), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (3) in section 524(a)(4)(C) ( 21 U.S.C. 360n(a)(4)(C) active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (4) in section 529(a)(4)(A)(ii) ( 21 U.S.C. 360ff(a)(4)(A)(ii) active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) (5) in section 565A(a)(4)(D) (21 U.S.C. 360bbb–4a(a)(4)(D)), by striking active ingredient (including any ester or salt of the active ingredient) active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))

Summary: Protecting Access to Safe and Effective Medicines Act of 2021 This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases. Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity. The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.