Introduced:
Jan 31, 2025
Policy Area:
Health
Congress.gov:
Bill Statistics
3
Actions
0
Cosponsors
1
Summaries
3
Subjects
1
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Latest Action
Jan 31, 2025
Referred to the House Committee on Energy and Commerce.
Summaries (1)
Introduced in House
- Jan 31, 2025
00
<p><strong>Prompt Approval of Safe Generic Drugs Act</strong></p><p>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.</p><p>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.</p><p>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. </p><p>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.</p>
Actions (3)
Referred to the House Committee on Energy and Commerce.
Type: IntroReferral
| Source: House floor actions
| Code: H11100
Jan 31, 2025
Introduced in House
Type: IntroReferral
| Source: Library of Congress
| Code: Intro-H
Jan 31, 2025
Introduced in House
Type: IntroReferral
| Source: Library of Congress
| Code: 1000
Jan 31, 2025
Subjects (3)
Drug safety, medical device, and laboratory regulation
Health
(Policy Area)
Marketing and advertising
Full Bill Text
Length: 3,708 characters
Version: Introduced in House
Version Date: Jan 31, 2025
Last Updated: Nov 11, 2025 6:21 AM
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 843 Introduced in House
(IH) ]
<DOC>
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,
[From the U.S. Government Publishing Office]
[H.R. 843 Introduced in House
(IH) ]
<DOC>
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.
This Act may be cited as the ``Prompt Approval of Safe Generic
Drugs Act''.
SEC. 2.
LABELING.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.
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
``
(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
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
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
(a) ;
``
(B) by an extension of such exclusivity under
section 505A or 505E; or
``
(C) by patent.
``
(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
(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.
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
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
(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>