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Prompt Approval of Safe Generic Drugs Act
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.
Summary
This bill amends federal drug approval rules to allow generic drugs to be approved even when they omit safety information from their labels due to brand-name drug exclusivity protections or patents. When a generic drug omits such protected safety information, the Food and Drug Administration must still require that the drug label include any additional safety information the FDA deems necessary for safe use. The bill clarifies that it does not affect the exclusivity rights of brand-name drugs or expand approval eligibility for applications that omit other protected labeling aspects. The change is intended to reduce delays in generic drug approvals that may occur when safety information cannot be used due to exclusivity protections held by the original manufacturer.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
Actions (2)
- Jan 31, 2025 Referred to the House Committee on Energy and Commerce. · house
- Jan 31, 2025 Introduced in House
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
IN THE HOUSE OF REPRESENTATIVES
January 31, 2025
Ms. Barragan 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 Representatives 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”.
SEC. 2. PROMPT APPROVAL OF DRUGS WHEN SAFETY INFORMATION 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 application has been submitted or approved under subsection (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 contraindications, warnings, precautions, dosing, administration, 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 pursuant to an application submitted under subsection (b)(2) or (j) that omits safety information described in paragraph (1) include a statement of any appropriate safety information that the Secretary considers necessary to assure safe use.
“(3) Availability and scope of exclusivity.—This subsection does not affect—
“(A) the availability or scope of exclusivity or an extension of exclusivity described in subparagraph
(A) or (B) of section 505A(o)(3);
“(B) the question of the eligibility for approval under this section of any application described in subsection (b)(2) or (j) that omits any other aspect of labeling protected by exclusivity 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 paragraphs
(1) and (2), the operation of this section or section 527.”. <all>
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