H.R. 843 — Prompt Approval of Safe Generic Drugs Act

Prompt Approval of Safe Generic Drugs Act

This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.

Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.

Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances.

For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 843 Introduced in House (IH)]

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119th CONGRESS
  1st Session
                                H. R. 843

 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

                            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.''.
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Prompt Approval of Safe Generic Drugs Act

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