Protecting Access to Safe and Effective Medicines Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 1857 To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity. IN THE HOUSE OF REPRESENTATIVES MARCH 11, 2021 Mr. SCHRADER (for himself and Mr. GUTHRIE) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Protecting Access to 4 Safe and Effective Medicines Act of 2021’’. 5 SEC. 2. CLARIFYING THE MEANING OF NEW CHEMICAL EN- 6 TITY. 7 Chapter V of the Federal Food, Drug, and Cosmetic 8 Act is amended— 9 (1) in section 505 (21 U.S.C. 355)— 10 VerDate Sep 11 2014 20:59 May 03, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1857.IH H1857 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 1857 IH (A) in subsection (c)(3)(E)— 1 (i) in clause (ii), by striking ‘‘active 2 ingredient (including any ester or salt of 3 the active ingredient)’’ and inserting ‘‘ac- 4 tive moiety (as defined by the Secretary in 5 section 314.3 of title 21, Code of Federal 6 Regulations (or any successor regula- 7 tions))’’; and 8 (ii) in clause (iii), by striking ‘‘active 9 ingredient (including any ester or salt of 10 the active ingredient)’’ and inserting ‘‘ac- 11 tive moiety (as defined by the Secretary in 12 section 314.3 of title 21, Code of Federal 13 Regulations (or any successor regula- 14 tions))’’; 15 (B) in subsection (j)(5)(F)— 16 (i) in clause (ii), by striking ‘‘active 17 ingredient (including any ester or salt of 18 the active ingredient)’’ and inserting ‘‘ac- 19 tive moiety (as defined by the Secretary in 20 section 314.3 of title 21, Code of Federal 21 Regulations (or any successor regula- 22 tions))’’; and 23 (ii) in clause (iii), by striking ‘‘active 24 ingredient (including any ester or salt of 25 VerDate Sep 11 2014 20:59 May 03, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1857.IH H1857 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 1857 IH the active ingredient)’’ and inserting ‘‘ac- 1 tive moiety (as defined by the Secretary in 2 section 314.3 of title 21, Code of Federal 3 Regulations (or any successor regula- 4 tions))’’; 5 (C) in subsection (l)(2)(A)(i), by striking 6 ‘‘active ingredient (including any ester or salt of 7 the active ingredient)’’ and inserting ‘‘active 8 moiety (as defined by the Secretary in section 9 314.3 of title 21, Code of Federal Regulations 10 (or any successor regulations))’’; 11 (D) in subsection (s), in the matter pre- 12 ceding paragraph (1), by striking ‘‘active ingre- 13 dient (including any ester or salt of the active 14 ingredient)’’ and inserting ‘‘active moiety (as 15 defined by the Secretary in section 314.3 of 16 title 21, Code of Federal Regulations (or any 17 successor regulations))’’; and 18 (E) in subsection (u)(1), in the matter pre- 19 ceding subparagraph (A)— 20 (i) by striking ‘‘active ingredient (in- 21 cluding any ester or salt of the active in- 22 gredient)’’ and inserting ‘‘active moiety (as 23 defined by the Secretary in section 314.3 24 VerDate Sep 11 2014 20:59 May 03, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1857.IH H1857 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 1857 IH of title 21, Code of Federal Regulations (or 1 any successor regulations))’’; and 2 (ii) by striking ‘‘same active ingre- 3 dient’’ and inserting ‘‘same active moiety’’; 4 (2) in section 512(c)(2)(F) (21 U.S.C. 5 360b(c)(2)(F))— 6 (A) in clause (i), by striking ‘‘active ingre- 7 dient (including any ester or salt of the active 8 ingredient)’’ and inserting ‘‘active moiety (as 9 defined by the Secretary in section 314.3 of 10 title 21, Code of Federal Regulations (or any 11 successor regulations))’’; 12 (B) in clause (ii), by striking ‘‘active ingre- 13 dient (including any ester or salt of the active 14 ingredient)’’ and inserting ‘‘active moiety (as 15 defined by the Secretary in section 314.3 of 16 title 21, Code of Federal Regulations (or any 17 successor regulations))’’; and 18 (C) in clause (v), by striking ‘‘active ingre- 19 dient (including any ester or salt of the active 20 ingredient)’’ and inserting ‘‘active moiety (as 21 defined by the Secretary in section 314.3 of 22 title 21, Code of Federal Regulations (or any 23 successor regulations))’’; 24 VerDate Sep 11 2014 20:59 May 03, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1857.IH H1857 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 1857 IH (3) in section 524(a)(4)(C) (21 U.S.C. 1 360n(a)(4)(C)), by striking ‘‘active ingredient (in- 2 cluding any ester or salt of the active ingredient)’’ 3 and inserting ‘‘active moiety (as defined by the Sec- 4 retary in section 314.3 of title 21, Code of Federal 5 Regulations (or any successor regulations))’’; 6 (4) in section 529(a)(4)(A)(ii) (21 U.S.C. 7 360ff(a)(4)(A)(ii)), by striking ‘‘active ingredient 8 (including any ester or salt of the active ingredient)’’ 9 and inserting ‘‘active moiety (as defined by the Sec- 10 retary in section 314.3 of title 21, Code of Federal 11 Regulations (or any successor regulations))’’; and 12 (5) in section 565A(a)(4)(D) (21 U.S.C. 13 360bbb–4a(a)(4)(D)), by striking ‘‘active ingredient 14 (including any ester or salt of the active ingredient)’’ 15 and inserting ‘‘active moiety (as defined by the Sec- 16 retary in section 314.3 of title 21, Code of Federal 17 Regulations (or any successor regulations))’’. 18 Æ VerDate Sep 11 2014 20:59 May 03, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H1857.IH H1857 pamtmann on DSKBC07HB2PROD with BILLS