Ensuring Innovation Act

116TH CONGRESS 2D SESSION S. 1636 AN ACT To amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 2 † S 1636 ES SECTION 1. CLARIFYING THE MEANING OF NEW CHEMICAL 1 ENTITY. 2 (a) IN GENERAL.—Chapter V of the Federal Food, 3 Drug, and Cosmetic Act is amended— 4 (1) in section 505 (21 U.S.C. 355)— 5 (A) in subsection (c)(3)(E), by striking 6 ‘‘active ingredient (including any ester or salt of 7 the active ingredient)’’ each place it appears 8 and inserting ‘‘active moiety (as defined by the 9 Secretary in section 314.3 of title 21, Code of 10 Federal Regulations (or any successor regula- 11 tions))’’; 12 (B) in subsection (j)(5)(F), by striking 13 ‘‘active ingredient (including any ester or salt of 14 the active ingredient)’’ each place it appears 15 and inserting ‘‘active moiety (as defined by the 16 Secretary in section 314.3 of title 21, Code of 17 Federal Regulations (or any successor regula- 18 tions))’’; 19 (C) in subsection (l)(2)(A)— 20 (i) by amending clause (i) to read as 21 follows: 22 ‘‘(i) not later than 30 days after the date 23 of approval of such applications— 24 ‘‘(I) for a drug, no active moiety (as 25 defined by the Secretary in section 314.3 26 3 † S 1636 ES of title 21, Code of Federal Regulations (or 1 any successor regulations)) of which has 2 been approved in any other application 3 under this section; or 4 ‘‘(II) for a biological product, no ac- 5 tive ingredient of which has been approved 6 in any other application under section 351 7 of the Public Health Service Act; and’’; 8 and 9 (ii) in clause (ii), by inserting ‘‘or bio- 10 logical product’’ before the period; 11 (D) by amending subsection (s) to read as 12 follows: 13 ‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—The 14 Secretary shall— 15 ‘‘(1) refer a drug or biological product to a 16 Food and Drug Administration advisory committee 17 for review at a meeting of such advisory committee 18 prior to the approval of such drug or biological if it 19 is— 20 ‘‘(A) a drug, no active moiety (as defined 21 by the Secretary in section 314.3 of title 21, 22 Code of Federal Regulations (or any successor 23 regulations)) of which has been approved in any 24 other application under this section; or 25 4 † S 1636 ES ‘‘(B) a biological product, no active ingre- 1 dient of which has been approved in any other 2 application under section 351 of the Public 3 Health Service Act; or 4 ‘‘(2) if the Secretary does not refer a drug or 5 biological product described in paragraph (1) to a 6 Food and Drug Administration advisory committee 7 prior to such approval, provide in the action letter 8 on the application for the drug or biological product 9 a summary of the reasons why the Secretary did not 10 refer the drug or biological product to an advisory 11 committee prior to approval.’’; and 12 (E) in subsection (u)(1), in the matter pre- 13 ceding subparagraph (A)— 14 (i) by striking ‘‘active ingredient (in- 15 cluding any ester or salt of the active in- 16 gredient)’’ and inserting ‘‘active moiety (as 17 defined by the Secretary in section 314.3 18 of title 21, Code of Federal Regulations (or 19 any successor regulations))’’; and 20 (ii) by striking ‘‘same active ingre- 21 dient’’ and inserting ‘‘same active moiety’’; 22 (2) in section 512(c)(2)(F) (21 U.S.C. 23 360b(c)(2)(F)), by striking ‘‘active ingredient (in- 24 cluding any ester or salt of the active ingredient)’’ 25 5 † S 1636 ES each place it appears and inserting ‘‘active moiety 1 (as defined by the Secretary in section 314.3 of title 2 21, Code of Federal Regulations (or any successor 3 regulations))’’; 4 (3) in section 524(a)(4) (21 U.S.C. 5 360n(a)(4)), by amending subparagraph (C) to read 6 as follows: 7 ‘‘(C) is for— 8 ‘‘(i) a human drug, no active moiety 9 (as defined by the Secretary in section 10 314.3 of title 21, Code of Federal Regula- 11 tions (or any successor regulations)) of 12 which has been approved in any other ap- 13 plication under section 505(b)(1); or 14 ‘‘(ii) a biological product, no active in- 15 gredient of which has been approved in any 16 other application under section 351 of the 17 Public Health Service Act.’’; 18 (4) in section 529(a)(4) (21 U.S.C. 21 U.S.C. 19 360ff(a)(4)), by striking subparagraphs (A) and (B) 20 and inserting the following: 21 ‘‘(A) is for a drug or biological product 22 that is for the prevention or treatment of a rare 23 pediatric disease; 24 ‘‘(B)(i) is for such a drug— 25 6 † S 1636 ES ‘‘(I) that contains no active moiety (as 1 defined by the Secretary in section 314.3 2 of title 21, Code of Federal Regulations (or 3 any successor regulations)) that has been 4 previously approved in any other applica- 5 tion under subsection (b)(1), (b)(2), or (j) 6 of section 505; and 7 ‘‘(II) that is the subject of an applica- 8 tion submitted under section 505(b)(1); or 9 ‘‘(ii) is for such a biological product— 10 ‘‘(I) that contains no active ingredient 11 that has been previously approved in any 12 other application under section 351(a) or 13 351(k) of the Public Health Service Act; 14 and 15 ‘‘(II) that is the subject of an applica- 16 tion submitted under section 351(a) of the 17 Public Health Service Act;’’; and 18 (5) in section 565A(a)(4) (21 U.S.C. 360bbb– 19 4a(a)(4)), by amending subparagraph (D) to read as 20 follows: 21 ‘‘(D) is for— 22 ‘‘(i) a human drug, no active moiety 23 (as defined by the Secretary in section 24 314.3 of title 21, Code of Federal Regula- 25 7 † S 1636 ES tions (or any successor regulations)) of 1 which has been approved in any other ap- 2 plication under section 505(b)(1); or 3 ‘‘(ii) a biological product, no active in- 4 gredient of which has been approved in any 5 other application under section 351 of the 6 Public Health Service Act.’’. 7 (b) TECHNICAL CORRECTIONS.—Chapter V of the 8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 9 et seq) is amended— 10 (1) in section 505 (21 U.S.C. 355)— 11 (A) in subsection (c)(3)(E), by repealing 12 clause (i); and 13 (B) in subsection (j)(5)(F), by repealing 14 clause (i); and 15 (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 16 355a(c)(1)(A)(i)(II)), by striking ‘‘(c)(3)(D)’’ and 17 inserting ‘‘(c)(3)(E)’’. 18 Passed the Senate December 14, 2020. Attest: Secretary. 116TH CONGRESS 2D SESSION S. 1636 AN ACT To amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical ex- clusivity.