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This bill would change how the FDA handles certain medicines when important safety information is added to the drug label. In simple terms, it would let the agency approve a drug even if the label does not yet include some safety details, as long as those details are protected by a patent or by legal exclusivity for another company’s drug. The goal is to help speed up approval of lower-cost drugs without forcing companies to wait for protected safety information to become available. At the same time, the FDA would still require a clear safety statement on the label so the drug can be used safely.
- If a drug application is filed as a lower-cost version or a related version of an already approved drug, the FDA could not reject it just because the label leaves out safety information that is still protected by law.
- The missing information could include warnings, precautions, dosage directions, how the drug should be taken, or other safety details.
- Even if the drug is approved without all of that protected information, the FDA would have to add a safety note to the label with any safety details it considers needed to protect patients.
- The bill would not change the length or size of existing patent or exclusivity protections, and it would not affect other parts of the drug approval rules beyond what is specifically described here.
Official Summaries
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.
Current Full Text
[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,
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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