MAGIC Act

I 116TH CONGRESS 1ST SESSION H. R. 4244 To provide for a pathway for chemically synthesized insulin to be approved under an abbreviated new drug application submitted under the Federal Food, Drug, and Cosmetic Act, and for other purposes. IN THE HOUSE OF REPRESENTATIVES SEPTEMBER 9, 2019 Mr. KELLY of Pennsylvania introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To provide for a pathway for chemically synthesized insulin to be approved under an abbreviated new drug applica- tion submitted under the Federal Food, Drug, and Cos- metic Act, 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 ‘‘Market Access for Ge- 4 neric Insulin Competition’’ or the ‘‘MAGIC Act’’. 5 VerDate Sep 11 2014 01:11 Sep 10, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4244.IH H4244 kjohnson on DSK79L0C42 with BILLS 2 •HR 4244 IH SEC. 2. PROVIDING FOR A PATHWAY FOR APPROVAL OF 1 CHEMICALLY SYNTHESIZED INSULIN UNDER 2 AN ABBREVIATED NEW DRUG APPLICATION. 3 (a) IN GENERAL.—Section 7002(e)(2) of the Patient 4 Protection and Affordable Care Act (42 U.S.C. 262 note) 5 is amended— 6 (1) in subparagraph (B), by redesignating 7 clauses (i) and (ii) as subclauses (I) and (II), respec- 8 tively, and moving the margins of such subclauses 9 (as so redesignated) two ems to the right; 10 (2) in subparagraph (A), by striking ‘‘such bio- 11 logical product’’ and inserting ‘‘(i) such biological 12 product’’; 13 (3) by redesignating subparagraph (B) as 14 clause (ii) and moving the margin of such clause (as 15 so redesignated) two ems to the right; 16 (4) in clause (ii) (as so redesignated), by strik- 17 ing the period at the end and inserting ‘‘; or’’; and 18 (5) by adding at the end the following: 19 ‘‘(B) notwithstanding paragraphs (3) and 20 (4), the application is submitted under sub- 21 section (j) of such section for chemically syn- 22 thesized insulin or any analogue of chemically 23 synthesized insulin for which the listed drug is 24 a biological product that is, pursuant to para- 25 VerDate Sep 11 2014 01:11 Sep 10, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4244.IH H4244 kjohnson on DSK79L0C42 with BILLS 3 •HR 4244 IH graph (4), deemed to be licensed under section 1 351 of the Public Health Service Act.’’. 2 (b) EFFECTIVE DATE.—The amendments made by 3 this section shall apply with respect to applications sub- 4 mitted on or after January 1, 2020. 5 Æ VerDate Sep 11 2014 01:11 Sep 10, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H4244.IH H4244 kjohnson on DSK79L0C42 with BILLS