A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.

To amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity. 1. Clarifying the meaning of new chemical entity (a) In general 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), 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), 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 amending clause (i) to read as follows: (i) not later than 30 days after the date of approval of such applications— (I) for a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under this section; or (II) for a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act; and ; and (ii) in clause (ii), by inserting or biological product (D) by amending subsection (s) to read as follows: (s) Referral to advisory committee The Secretary shall— (1) refer a drug or biological product to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee prior to the approval of such drug or biological if it is— (A) a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under this section; or (B) a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act; or (2) if the Secretary does not refer a drug or biological product described in paragraph (1) to a Food and Drug Administration advisory committee prior to such approval, provide in the action letter on the application for the drug or biological product a summary of the reasons why the Secretary did not refer the drug or biological product to an advisory committee prior to approval. ; and (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) 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) ( 21 U.S.C. 360n(a)(4) (C) is for— (i) a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 505(b)(1); or (ii) a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act. ; (4) in section 529(a)(4) ( 21 U.S.C. 360ff(a)(4) (A) is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease; (B) (i) is for such a drug— (I) that contains no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been previously approved in any other application under subsection (b)(1), (b)(2), or (j) of section 505; and (II) that is the subject of an application submitted under section 505(b)(1); or (ii) is for such a biological product— (I) that contains no active ingredient that has been previously approved in any other application under section 351(a) or 351(k) of the Public Health Service Act; and (II) that is the subject of an application submitted under section 351(a) of the Public Health Service Act; ; and (5) in section 565A(a)(4) (21 U.S.C. 360bbb–4a(a)(4)), by amending subparagraph (D) to read as follows: (D) is for— (i) a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 505(b)(1); or (ii) a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act. . (b) Technical corrections Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 (1) in section 505 ( 21 U.S.C. 355 (A) in subsection (c)(3)(E), by repealing clause (i); and (B) in subsection (j)(5)(F), by repealing clause (i); and (2) in section 505A(c)(1)(A)(i)(II) ( 21 U.S.C. 355a(c)(1)(A)(i)(II) (c)(3)(D) (c)(3)(E)

Summary: 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.