Lower Insulin Costs Now Act

I 116TH CONGRESS 1ST SESSION H. R. 5444 To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes. IN THE HOUSE OF REPRESENTATIVES DECEMBER 17, 2019 Ms. UNDERWOOD (for herself, Ms. SCHAKOWSKY, Mr. GUTHRIE, Mr. KELLY of Pennsylvania, and Mr. LEVIN of Michigan) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain prod- ucts from approval as a drug to licensure as a biological product, and for other purposes. 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 ‘‘Lower Insulin Costs 4 Now Act’’. 5 VerDate Sep 11 2014 01:45 Dec 27, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5444.IH H5444 kjohnson on DSK79L0C42 with BILLS 2 •HR 5444 IH SEC. 2. STREAMLINING THE TRANSITION OF BIOLOGICAL 1 PRODUCTS. 2 Section 7002(e)(4) of the Biologics Price Competition 3 and Innovation Act of 2009 (Public Law 111–148) is 4 amended— 5 (1) by striking ‘‘An approved application’’ and 6 inserting the following: 7 ‘‘(A) IN GENERAL.—An approved applica- 8 tion’’; and 9 (2) by adding at the end the following: 10 ‘‘(B) TREATMENT OF CERTAIN APPLICA- 11 TIONS.— 12 ‘‘(i) IN GENERAL.—With respect to an 13 application for a biological product sub- 14 mitted under subsection (b) or (j) of sec- 15 tion 505 of the Federal Food, Drug, and 16 Cosmetic Act (21 U.S.C. 355) that is filed 17 not later than March 23, 2019, and is not 18 approved as of March 23, 2020, the Sec- 19 retary shall continue to review such appli- 20 cation under such section 505, after March 21 23, 2020. 22 ‘‘(ii) EFFECT ON LISTED DRUGS.— 23 Only for purposes of carrying out clause 24 (i), with respect to any applicable listed 25 VerDate Sep 11 2014 01:45 Dec 27, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5444.IH H5444 kjohnson on DSK79L0C42 with BILLS 3 •HR 5444 IH drug with respect to such application, the 1 following shall apply: 2 ‘‘(I) Any drug that is a biological 3 product that has been deemed licensed 4 under section 351 of the Public 5 Health Service Act (42 U.S.C. 262) 6 pursuant to subparagraph (A) and 7 that is referenced in an application 8 described in clause (i), shall continue 9 to be identified as a listed drug on the 10 list published pursuant to section 11 505(j)(7) of the Federal Food, Drug, 12 and Cosmetic Act, and the informa- 13 tion for such drug on such list shall 14 not be revised after March 20, 2020, 15 until— 16 ‘‘(aa) such drug is removed 17 from such list in accordance with 18 subclause (III) or subparagraph 19 (C) of such section 505(j)(7); or 20 ‘‘(bb) this subparagraph no 21 longer has force or effect. 22 ‘‘(II) Any drug that is a biologi- 23 cal product that has been deemed li- 24 censed under section 351 of the Pub- 25 VerDate Sep 11 2014 01:45 Dec 27, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5444.IH H5444 kjohnson on DSK79L0C42 with BILLS 4 •HR 5444 IH lic Health Service Act (42 U.S.C. 1 262) pursuant to subparagraph (A) 2 and that is referenced in an applica- 3 tion described in clause (i) shall be 4 subject only to requirements applica- 5 ble to biological products licensed 6 under such section. 7 ‘‘(III) Upon approval under sub- 8 section (c) or (j) of section 505 of the 9 Federal Food, Drug, and Cosmetic 10 Act of an application described in 11 clause (i), the Secretary shall remove 12 from the list published pursuant to 13 section 505(j)(7) of the Federal Food, 14 Drug, and Cosmetic Act any listed 15 drug that is a biological product that 16 has been deemed licensed under sec- 17 tion 351 of the Public Health Service 18 Act pursuant to subparagraph (A) 19 and that is referenced in such ap- 20 proved application, unless such listed 21 drug is referenced in one or more ad- 22 ditional applications described in 23 clause (i). 24 VerDate Sep 11 2014 01:45 Dec 27, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5444.IH H5444 kjohnson on DSK79L0C42 with BILLS 5 •HR 5444 IH ‘‘(iii) DEEMED LICENSURE.—Upon 1 approval of an application described in 2 clause (i), such approved application shall 3 be deemed to be a license for the biological 4 product under section 351 of the Public 5 Health Service Act. 6 ‘‘(iv) RULE OF CONSTRUCTION.— 7 ‘‘(I) APPLICATION OF CERTAIN 8 PROVISIONS.— 9 ‘‘(aa) PATENT CERTIFI- 10 CATION OR STATEMENT.—An ap- 11 plication described in clause (i) 12 shall contain a patent certifi- 13 cation or statement described in, 14 as applicable, section 505(b)(2) 15 of the Federal Food, Drug, and 16 Cosmetic Act or clauses (vii) and 17 (viii) of section 505(j)(2)(A) of 18 such Act and, with respect to any 19 listed drug referenced in such ap- 20 plication, comply with related re- 21 quirements concerning any timely 22 filed patent information listed 23 pursuant to section 505(j)(7). 24 VerDate Sep 11 2014 01:45 Dec 27, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5444.IH H5444 kjohnson on DSK79L0C42 with BILLS 6 •HR 5444 IH ‘‘(bb) DATE OF AP- 1 PROVAL.—The earliest possible 2 date on which any pending appli- 3 cation described in clause (i) may 4 be approved shall be determined 5 based on— 6 ‘‘(AA) the last expira- 7 tion date of any applicable 8 period of exclusivity that 9 would prevent such approval 10 and that is described in sec- 11 tion 505(c)(3)(E), 12 505(j)(5)(B)(iv), 13 505(j)(5)(F), 505A, 505E, 14 or 527 of the Federal Food, 15 Drug, and Cosmetic Act; 16 and 17 ‘‘(BB) if the application 18 was submitted pursuant to 19 section 505(b)(2) of the 20 Federal Food, Drug, and 21 Cosmetic Act and references 22 any listed drug, the last ap- 23 plicable date determined 24 under subparagraph (A), 25 VerDate Sep 11 2014 01:45 Dec 27, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5444.IH H5444 kjohnson on DSK79L0C42 with BILLS 7 •HR 5444 IH (B), or (C) of section 1 505(c)(3) of such Act, or, if 2 the application was sub- 3 mitted under section 505(j) 4 of such Act, the last applica- 5 ble date determined under 6 clause (i), (ii), or (iii) of sec- 7 tion 505(j)(5)(B). 8 ‘‘(II) EXCLUSIVITY.—Nothing in 9 this subparagraph shall be construed 10 to affect section 351(k)(7)(D) of the 11 Public Health Service Act. 12 ‘‘(v) LISTING.—The Secretary may 13 continue to review an application after 14 March 23, 2020, pursuant to clause (i), 15 and continue to identify any applicable list- 16 ed drug pursuant to clause (ii) on the list 17 published pursuant to section 505(j)(7) of 18 the Federal Food, Drug, and Cosmetic 19 Act, even if such review or listing may re- 20 veal the existence of such application and 21 the identity of any listed drug for which 22 the investigations described in section 23 505(b)(1)(A) of the Federal Food, Drug, 24 and Cosmetic Act are relied upon by the 25 VerDate Sep 11 2014 01:45 Dec 27, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5444.IH H5444 kjohnson on DSK79L0C42 with BILLS 8 •HR 5444 IH applicant for approval of the pending ap- 1 plication. Nothing in this subparagraph 2 shall be construed as authorizing the Sec- 3 retary to disclose any other information 4 that is a trade secret or confidential infor- 5 mation described in section 552(b)(4) of 6 title 5, United States Code. 7 ‘‘(vi) SUNSET.—Beginning on October 8 1, 2022, this subparagraph shall have no 9 force or effect and any applications de- 10 scribed in clause (i) that have not been ap- 11 proved shall be deemed withdrawn.’’. 12 Æ VerDate Sep 11 2014 01:45 Dec 27, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H5444.IH H5444 kjohnson on DSK79L0C42 with BILLS