II 

117TH CONGRESS 

1ST SESSION S. 415 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

scope of new chemical exclusivity. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 24, 2021 

Mr. CASSIDY (for himself, Ms. SMITH, and Mr. MARSHALL) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the scope of new chemical exclusivity. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. CLARIFYING THE MEANING OF NEW CHEMICAL 

4 ENTITY. 

5 (a) IN GENERAL.—Chapter V of the Federal Food, 

6 Drug, and Cosmetic Act is amended— 

7 (1) in section 505 (21 U.S.C. 355)— 

8 (A) in subsection (c)(3)(E), by striking 

9 ‘‘active ingredient (including any ester or salt of 

10 the active ingredient)’’ each place it appears 


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1 and inserting ‘‘active moiety (as defined by the 

2 Secretary in section 314.3 of title 21, Code of 

3 Federal Regulations (or any successor regula4 tions))’’; 

5 (B) in subsection (j)(5)(F), 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 regula11 tions))’’; 

12 (C) in subsection (l)(2)(A)— 

13 (i) by amending clause (i) to read as 

14 follows: 

15 ‘‘(i) not later than 30 days after the date 

16 of approval of such applications— 

17 ‘‘(I) for a drug, no active moiety (as 

18 defined by the Secretary in section 314.3 

19 of title 21, Code of Federal Regulations (or 

20 any successor regulations)) of which has 

21 been approved in any other application 

22 under this section; or 

23 ‘‘(II) for a biological product, no ac24 tive ingredient of which has been approved 

25 in any other application under section 351 


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1 of the Public Health Service Act; and’’; 

2 and 

3 (ii) in clause (ii), by inserting ‘‘or bio4 logical product’’ before the period; 

5 (D) by amending subsection (s) to read as 

6 follows: 

7 ‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—The 

8 Secretary shall— 

9 ‘‘(1) refer a drug or biological product to a 

10 Food and Drug Administration advisory committee 

11 for review at a meeting of such advisory committee 

12 prior to the approval of such drug or biological if it 

13 is— 

14 ‘‘(A) a drug, no active moiety (as defined 

15 by the Secretary in section 314.3 of title 21, 

16 Code of Federal Regulations (or any successor 

17 regulations)) of which has been approved in any 

18 other application under this section; or 

19 ‘‘(B) a biological product, no active ingre20 dient of which has been approved in any other 

21 application under section 351 of the Public 

22 Health Service Act; or 

23 ‘‘(2) if the Secretary does not refer a drug or 

24 biological product described in paragraph (1) to a 

25 Food and Drug Administration advisory committee 


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1 prior to such approval, provide in the action letter 

2 on the application for the drug or biological product 

3 a summary of the reasons why the Secretary did not 

4 refer the drug or biological product to an advisory 

5 committee prior to approval.’’; and 

6 (E) in subsection (u)(1), in the matter pre7 ceding subparagraph (A)— 

8 (i) by striking ‘‘active ingredient (in9 cluding any ester or salt of the active in10 gredient)’’ and inserting ‘‘active moiety (as 

11 defined by the Secretary in section 314.3 

12 of title 21, Code of Federal Regulations (or 

13 any successor regulations))’’; and 

14 (ii) by striking ‘‘same active ingre15 dient’’ and inserting ‘‘same active moiety’’; 

16 (2) in section 512(c)(2)(F) (21 U.S.C. 

17 360b(c)(2)(F)), by striking ‘‘active ingredient (in18 cluding any ester or salt of the active ingredient)’’ 

19 each place it appears and inserting ‘‘active moiety 

20 (as defined by the Secretary in section 314.3 of title 

21 21, Code of Federal Regulations (or any successor 

22 regulations))’’; 

23 (3) in section 524(a)(4) (21 U.S.C. 

24 360n(a)(4)), by amending subparagraph (C) to read 

25 as follows: 


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1 ‘‘(C) is for— 

2 ‘‘(i) a human drug, no active moiety 

3 (as defined by the Secretary in section 

4 314.3 of title 21, Code of Federal Regula5 tions (or any successor regulations)) of 

6 which has been approved in any other ap7 plication under section 505(b)(1); or 

8 ‘‘(ii) a biological product, no active in9 gredient of which has been approved in any 

10 other application under section 351 of the 

11 Public Health Service Act.’’; 

12 (4) in section 529(a)(4) (21 U.S.C. 

13 360ff(a)(4)), by striking subparagraphs (A) and (B) 

14 and inserting the following: 

15 ‘‘(A) is for a drug or biological product 

16 that is for the prevention or treatment of a rare 

17 pediatric disease; 

18 ‘‘(B)(i) is for such a drug— 

19 ‘‘(I) that contains no active moiety (as 

20 defined by the Secretary in section 314.3 

21 of title 21, Code of Federal Regulations (or 

22 any successor regulations)) that has been 

23 previously approved in any other applica24 tion under subsection (b)(1), (b)(2), or (j) 

25 of section 505; and 


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1 ‘‘(II) that is the subject of an applica2 tion submitted under section 505(b)(1); or 

3 ‘‘(ii) is for such a biological product— 

4 ‘‘(I) that contains no active ingredient 

5 that has been previously approved in any 

6 other application under section 351(a) or 

7 351(k) of the Public Health Service Act; 

8 and 

9 ‘‘(II) that is the subject of an applica10 tion submitted under section 351(a) of the 

11 Public Health Service Act;’’; and 

12 (5) in section 565A(a)(4) (21 U.S.C. 360bbb– 

13 4a(a)(4)), by amending subparagraph (D) to read as 

14 follows: 

15 ‘‘(D) is for— 

16 ‘‘(i) a human drug, no active moiety 

17 (as defined by the Secretary in section 

18 314.3 of title 21, Code of Federal Regula19 tions (or any successor regulations)) of 

20 which has been approved in any other ap21 plication under section 505(b)(1); or 

22 ‘‘(ii) a biological product, no active in23 gredient of which has been approved in any 

24 other application under section 351 of the 

25 Public Health Service Act.’’. 


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1 (b) TECHNICAL CORRECTIONS.—Chapter V of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

3 et seq.) is amended— 

4 (1) in section 505 (21 U.S.C. 355)— 

5 (A) in subsection (c)(3)(E), by repealing 

6 clause (i); and 

7 (B) in subsection (j)(5)(F), by repealing 

8 clause (i); and 

9 (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 

10 355a(c)(1)(A)(i)(II)), by striking ‘‘(c)(3)(D)’’ and 

11 inserting ‘‘(c)(3)(E)’’. 

Æ 


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