[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2513 Introduced in Senate (IS)]
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119th CONGRESS
1st Session
S. 2513
To amend the Federal Food, Drug, and Cosmetic Act with respect to
transparency and reporting regarding over-the-counter drug monograph
activities, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 29, 2025
Mr. Kaine introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to
transparency and reporting regarding over-the-counter drug monograph
activities, 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 ``OTC Monograph Drug User Fee
Transparency Act''.
SEC. 2. OTC MONOGRAPH DRUG PERFORMANCE REPORTS.
(a) Performance Report.--Section 744N of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-73) is amended--
(1) in subsection (a)--
(A) by striking ``Beginning with'' and inserting
the following:
``(1) In general.--Beginning with'';
(B) by striking ``section 3861(b)'' and inserting
``section 3861''; and
(C) by adding at the end the following:
``(2) Additional information.--Beginning with fiscal year
2026, the annual report under this subsection shall include--
``(A) the progress of the Food and Drug
Administration in achieving the goals, and future plans
for meeting the goals, including--
``(i) the number of Tier 1 OTC monograph
order requests for which a proposed order was
issued, and the number of such requests for
which a final order was issued, in the previous
fiscal year;
``(ii) the number of Tier 2 OTC monograph
order requests for which a proposed order was
issued, and the number of such requests for
which a final order was issued, in the previous
fiscal year;
``(iii) the number of specified safety OTC
monograph order requests for which a proposed
order was issued, and the number of such
requests for which a final order was issued, in
the previous fiscal year;
``(iv) the number of generally recognized
as safe and effective finalization OTC
monograph order requests for which a proposed
order was issued, and the number of such
requests for which a final order was issued, in
the previous fiscal year;
``(v) the average timeline for processing
OTC monograph order requests, in the aggregate
and by submission type, in the previous fiscal
year; and
``(vi) postmarket safety activities with
respect to OTC monograph drugs, including--
``(I) collecting, developing, and
reviewing safety information on OTC
monograph drugs, including adverse
event reports;
``(II) developing and using
improved analytical tools, adverse
event data-collection systems,
including information technology
systems, to assess potential safety
problems, including access to external
databases; and
``(III) activities under section
760; and
``(B) information regarding registration of OTC
monograph drug facilities and contract manufacturing
organization facilities and payment of registration
fees by such facilities, including--
``(i) the OTC monograph drug facilities and
contract manufacturing organization facilities
that were first registered under section 510(c)
or 510(i) in the fiscal year; and
``(ii) for each OTC monograph drug facility
and contract manufacturing organization
facility that was assessed a facility fee under
section 744M(a) in the fiscal year, whether the
facility paid such fee.
``(3) Confidentiality.--Nothing in paragraph (2) shall be
construed to authorize the disclosure of information that is
prohibited from disclosure under section 301(j) of this Act or
section 1905 of title 18, United States Code, or that is
subject to withholding under section 552(b)(4) of title 5,
United States Code.''; and
(2) by adding at the end of subsection (d) the following:
``(4) Minutes of negotiation meetings.--
``(A) Public availability.--The Secretary shall
make publicly available, on the public website of the
Food and Drug Administration, robust written minutes of
all negotiation meetings conducted under this
subsection between the Food and Drug Administration and
the regulated industry, not later than 30 days after
each such negotiation meeting.
``(B) Content.--The robust written minutes
described under subparagraph (A) shall contain, in
detail, any substantive proposal made by any party to
the negotiations as well as significant controversies
or differences of opinion during the negotiations and
their resolution.''.
(b) GAO Report.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report assessing
the supply chain of over-the-counter monograph drugs.
(2) Contents.--The report required under paragraph (1)
shall include an assessment of--
(A) information the Food and Drug Administration
and others have reported about the overall stability of
the supply chain of over-the-counter monograph drugs;
(B) what information is collected by the Food and
Drug Administration with respect to the supply chain of
over-the-counter monograph drugs;
(C) how the Food and Drug Administration uses
information collected on the supply chain of over-the-
counter monograph drugs to inform regulatory decisions;
(D) how the Food and Drug Administration
coordinates with other Federal agencies to monitor and
mitigate disruptions to the supply chain of over-the-
counter monograph drugs; and
(E) the unique characteristics of the over-the-
counter monograph drug marketplace and what additional
authorities or information, if any, the Food and Drug
Administration and others have identified as being
necessary to ensure the stability of the supply chain
of over-the-counter monograph drugs.
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