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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Prompt Approval of 
Safe Generic Drugs Act’’. 
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SEC. 2. PROMPT APPROVAL OF DRUGS WHEN SAFETY IN-
FORMATION IS ADDED TO LABELING. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the 
following: 
‘‘(aa) PROMPT APPROVAL OF DRUGS WHEN SAFETY 
INFORMATION IS ADDED TO LABELING.— 
‘‘(1) GENERAL RULE.—A drug for which an ap-
plication has been submitted or approved under sub-
section (b)(2) or (j) shall not be considered ineligible 
for approval under this section or misbranded under 
section 502 on the basis that the labeling of the 
drug omits safety information, including contra-
indications, warnings, precautions, dosing, adminis-
tration, or other information pertaining to safety, 
when the omitted safety information is protected— 
‘‘(A) by exclusivity under clause (iii) or (iv) 
of subsection (c)(3)(E), clause (iii) or (iv) of 
subsection (j)(5)(F), or section 527(a); 
‘‘(B) by an extension of such exclusivity 
under section 505A or 505E; or 
‘‘(C) by patent. 
‘‘(2) LABELING.—Notwithstanding clauses (iii) 
and (iv) of subsection (c)(3)(E), clauses (iii) and (iv) 
of subsection (j)(5)(F), or section 527, the Secretary 
shall require that the labeling of a drug approved 
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pursuant to an application submitted under sub-
section (b)(2) or (j) that omits safety information 
described in paragraph (1) include a statement of 
any appropriate safety information that the Sec-
retary considers necessary to assure safe use. 
‘‘(3) AVAILABILITY
AND
SCOPE
OF
EXCLU-
SIVITY.—This subsection does not affect— 
‘‘(A) the availability or scope of exclusivity 
or an extension of exclusivity described in sub-
paragraph (A) or (B) of section 505A(o)(3); 
‘‘(B) the question of the eligibility for ap-
proval under this section of any application de-
scribed in subsection (b)(2) or (j) that omits 
any other aspect of labeling protected by exclu-
sivity under— 
‘‘(i) clause (iii) or (iv) of subsection 
(c)(3)(E); 
‘‘(ii) clause (iii) or (iv) of subsection 
(j)(5)(F); or 
‘‘(iii) section 527(a); or 
‘‘(C) except as expressly provided in para-
graphs (1) and (2), the operation of this section 
or section 527.’’. 
Æ 
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