II 

117TH CONGRESS 

2D SESSION S. 4338 

To provide for increased transparency in generic drug applications. 

IN THE SENATE OF THE UNITED STATES 

MAY 26, 2022 

Ms. HASSAN (for herself and Mr. PAUL) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To provide for increased transparency in generic drug 

applications. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Increasing Trans5 parency in Generic Drug Applications Act’’. 

6 SEC. 2. INCREASING TRANSPARENCY IN GENERIC DRUG 

7 APPLICATIONS. 

8 (a) IN GENERAL.—Section 505(j)(3) of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 

10 amended by adding at the end the following: 


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1 ‘‘(H)(i) Upon request (in controlled correspondence 

2 or otherwise) by a person that has submitted or intends 

3 to submit an abbreviated application under this subsection 

4 for a drug that is generally required by regulation or rec5 ommended in guidance to contain the same inactive ingre6 dients in the same concentration as the listed drug re7 ferred to or for which there is a scientific justification that 

8 an in vitro approach can be used to demonstrate bio9 equivalence based on certain qualitative or quantitative 

10 criteria with respect to an inactive ingredient, or on the 

11 Secretary’s own initiative during the review of an applica12 tion under this subsection for such a drug, the Secretary 

13 shall inform the person whether such drug is qualitatively 

14 and quantitatively the same as the listed drug. 

15 ‘‘(ii) If the Secretary determines that such drug is 

16 not qualitatively or quantitatively the same as the listed 

17 drug, the Secretary shall identify and disclose to the per18 son— 

19 ‘‘(I) the ingredient or ingredients that cause the 

20 drug not to be qualitatively or quantitatively the 

21 same as the listed drug; and 

22 ‘‘(II) for any ingredient for which there is an 

23 identified quantitative deviation, the amount of such 

24 deviation. 


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1 ‘‘(iii) If the Secretary determines that such drug is 

2 qualitatively and quantitatively the same as the listed 

3 drug, the Secretary shall not change or rescind such deter4 mination after the submission of an abbreviated applica5 tion for such drug under this subsection unless— 

6 ‘‘(I) the formulation of the listed drug has been 

7 changed and the Secretary has determined that the 

8 prior listed drug formulation was withdrawn for rea9 sons of safety or effectiveness; or 

10 ‘‘(II) the Secretary makes a written determina11 tion that the prior determination must be changed 

12 because an error has been identified. 

13 ‘‘(iv) If the Secretary makes a written determination 

14 described in clause (iii)(II), the Secretary shall provide no15 tice and a copy of the written determination to the person 

16 making the request under clause (i). 

17 ‘‘(v) The disclosures required by this subparagraph 

18 are disclosures authorized by law, including for purposes 

19 of section 1905 of title 18, United States Code.’’. 

20 (b) GUIDANCE.— 

21 (1) IN GENERAL.—Not later than one year 

22 after the date of enactment of this Act, the Sec23 retary of Health and Human Services shall issue 

24 draft guidance, or update guidance, describing how 

25 the Secretary will determine whether a drug is qualiVerDate Sep 11 2014 03:10 Jun 02, 2022 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4338.IS S4338

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1 tatively and quantitatively the same as the listed 

2 drug (as such terms are used in section 

3 505(j)(3)(H) of the Federal Food, Drug, and Cos4 metic Act, as added by subsection (a)), including 

5 with respect to assessing pH adjusters. 

6 (2) PROCESS.—In issuing guidance under this 

7 subsection, the Secretary of Health and Human 

8 Services shall— 

9 (A) publish draft guidance; 

10 (B) provide a period of at least 60 days for 

11 comment on the draft guidance; and 

12 (C) after considering any comments re13 ceived and not later than one year after the 

14 close of the comment period on the draft guid15 ance, publish final guidance. 

16 (c) APPLICABILITY.—Section 505(j)(3)(H) of the 

17 Federal Food, Drug, and Cosmetic Act, as added by sub18 section (a), applies beginning on the date of enactment 

19 of this Act, irrespective of the date on which the guidance 

20 required by subsection (b) is finalized. 

Æ 


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