To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

I 118TH CONGRESS 1ST SESSION H. R. 3839 To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. IN THE HOUSE OF REPRESENTATIVES JUNE 6, 2023 Mr. DUNN of Florida (for himself and Ms. KUSTER) 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 increase transparency in generic drug applications. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. INCREASING TRANSPARENCY IN GENERIC 3 DRUG APPLICATIONS. 4 (a) IN GENERAL.—Section 505(j)(3) of the Federal 5 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 6 amended by adding at the end the following: 7 ‘‘(H)(i) Upon request (in controlled correspondence 8 or an analogous process) by a person that has submitted 9 or intends to submit an abbreviated application under this 10 VerDate Sep 11 2014 23:39 Jul 01, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3839.IH H3839 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3839 IH subsection for a drug that is required by regulation to con- 1 tain one or more of the same inactive ingredients in the 2 same concentrations as the listed drug referred to, or for 3 which the Secretary determines there is a scientific jus- 4 tification for an approach that is in vitro in whole or in 5 part to be used to demonstrate bioequivalence for a drug 6 if such a drug contains one or more of the same inactive 7 ingredients in the same concentrations as the listed drug, 8 the Secretary shall inform the person whether such drug 9 is qualitatively and quantitatively the same as the listed 10 drug. The Secretary may also provide such information 11 to such a person on the Secretary’s own initiative during 12 the review of an abbreviated application under this sub- 13 section for such drug. 14 ‘‘(ii) Notwithstanding section 301(j), if the Secretary 15 determines that such drug is not qualitatively or quan- 16 titatively the same as the listed drug, the Secretary shall 17 identify and disclose to the person— 18 ‘‘(I) the ingredient or ingredients that cause 19 such drug not to be qualitatively or quantitatively 20 the same as the listed drug; and 21 ‘‘(II) for any ingredient for which there is an 22 identified quantitative deviation, the amount of such 23 deviation. 24 VerDate Sep 11 2014 23:39 Jul 01, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3839.IH H3839 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3839 IH ‘‘(iii) If the Secretary determines that such drug is 1 qualitatively and quantitatively the same as the listed 2 drug, the Secretary shall not change or rescind such deter- 3 mination after the submission of an abbreviated applica- 4 tion for such drug under this subsection unless— 5 ‘‘(I) the formulation of the listed drug has been 6 changed and the Secretary has determined that the 7 prior listed drug formulation was withdrawn for rea- 8 sons of safety or effectiveness; or 9 ‘‘(II) the Secretary makes a written determina- 10 tion that the prior determination must be changed 11 because an error has been identified. 12 ‘‘(iv) If the Secretary makes a written determination 13 described in clause (iii)(II), the Secretary shall provide no- 14 tice and a copy of the written determination to the person 15 making the request under clause (i). 16 ‘‘(v) The disclosures required by this subparagraph 17 are disclosures authorized by law, including for purposes 18 of section 1905 of title 18, United States Code.’’. 19 (b) GUIDANCE.— 20 (1) IN GENERAL.—Not later than one year 21 after the date of enactment of this Act, the Sec- 22 retary of Health and Human Services shall issue 23 draft guidance, or update guidance, describing how 24 the Secretary will determine whether a drug is quali- 25 VerDate Sep 11 2014 23:39 Jul 01, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3839.IH H3839 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3839 IH tatively and quantitatively the same as the listed 1 drug (as such terms are used in section 2 505(j)(3)(H) of the Federal Food, Drug, and Cos- 3 metic Act, as added by subsection (a)), including 4 with respect to assessing pH adjusters. 5 (2) PROCESS.—In issuing guidance under this 6 subsection, the Secretary of Health and Human 7 Services shall— 8 (A) publish draft guidance; 9 (B) provide a period of at least 60 days for 10 comment on the draft guidance; and 11 (C) after considering any comments re- 12 ceived and not later than one year after the 13 close of the comment period on the draft guid- 14 ance, publish final guidance. 15 (c) APPLICABILITY.—Section 505(j)(3)(H) of the 16 Federal Food, Drug, and Cosmetic Act, as added by sub- 17 section (a), applies beginning on the date of enactment 18 of this Act, irrespective of the date on which the guidance 19 required by subsection (b) is finalized. 20 Æ VerDate Sep 11 2014 23:39 Jul 01, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H3839.IH H3839 kjohnson on DSK79L0C42PROD with BILLS