I 

118TH CONGRESS 

2D SESSION H. R. 9616 

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 

prompt approval of drugs when safety information is added to labeling, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 17, 2024 

Ms. BARRAGA ́N 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 

provide for the prompt approval of drugs when safety 

information is added to labeling, and for other purposes. 

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 ‘‘Prompt Approval of 

5 Safe Generic Drugs Act’’. 


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1 SEC. 2. PROMPT APPROVAL OF DRUGS WHEN SAFETY IN2 FORMATION IS ADDED TO LABELING. 

3 Section 505 of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 355) is amended by adding at the end the 

5 following: 

6 ‘‘(aa) PROMPT APPROVAL OF DRUGS WHEN SAFETY

7 INFORMATION IS ADDED TO LABELING.— 

8 ‘‘(1) GENERAL RULE.—A drug for which an ap9 plication has been submitted or approved under sub10 section (b)(2) or (j) shall not be considered ineligible 

11 for approval under this section or misbranded under 

12 section 502 on the basis that the labeling of the 

13 drug omits safety information, including contra14 indications, warnings, precautions, dosing, adminis15 tration, or other information pertaining to safety, 

16 when the omitted safety information is protected— 

17 ‘‘(A) by exclusivity under clause (iii) or (iv) 

18 of subsection (c)(3)(E), clause (iii) or (iv) of 

19 subsection (j)(5)(F), or section 527(a); 

20 ‘‘(B) by an extension of such exclusivity 

21 under section 505A or 505E; or 

22 ‘‘(C) by patent. 

23 ‘‘(2) LABELING.—Notwithstanding clauses (iii) 

24 and (iv) of subsection (c)(3)(E), clauses (iii) and (iv) 

25 of subsection (j)(5)(F), or section 527, the Secretary 

26 shall require that the labeling of a drug approved 


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•HR 9616 IH

1 pursuant to an application submitted under sub2 section (b)(2) or (j) that omits safety information 

3 described in paragraph (1) include a statement of 

4 any appropriate safety information that the Sec5 retary considers necessary to assure safe use. 

6 ‘‘(3) AVAILABILITY AND SCOPE OF EXCLU7 SIVITY.—This subsection does not affect— 

8 ‘‘(A) the availability or scope of exclusivity 

9 or an extension of exclusivity described in sub10 paragraph (A) or (B) of section 505A(o)(3); 

11 ‘‘(B) the question of the eligibility for ap12 proval under this section of any application de13 scribed in subsection (b)(2) or (j) that omits 

14 any other aspect of labeling protected by exclu15 sivity under— 

16 ‘‘(i) clause (iii) or (iv) of subsection 

17 (c)(3)(E); 

18 ‘‘(ii) clause (iii) or (iv) of subsection 

19 (j)(5)(F); or 

20 ‘‘(iii) section 527(a); or 

21 ‘‘(C) except as expressly provided in para22 graphs (1) and (2), the operation of this section 

23 or section 527.’’. 

Æ 


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