[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2292 Reported in Senate (RS)]
<DOC>
Calendar No. 152
119th CONGRESS
1st Session
S. 2292
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user fee program for over-the-counter monograph drugs, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 15, 2025
Mr. Banks (for himself, Mr. Kaine, Mr. Kim, and Mr. Husted) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
September 8, 2025
Reported by Mr. Cassidy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user fee program for over-the-counter monograph drugs, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Over-the-Counter Monograph
Drug User Fee Amendments''.</DELETED>
<DELETED>SEC. 2. FINDING.</DELETED>
<DELETED> Congress finds that the fees authorized by the amendments
made in this Act will be dedicated to OTC monograph drug activities, as
set forth in the goals identified for purposes of part 10 of subchapter
C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-71 et seq.), in the letters from the Secretary of Health and Human
Services to the Chairman of the Committee on Energy and Commerce of the
House of Representatives and the Chairman of the Committee on Health,
Education, Labor, and Pensions of the Senate, as set forth in the
Congressional Record.</DELETED>
<DELETED>SEC. 3. DEFINITIONS.</DELETED>
<DELETED> Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-71(9)(A)) is amended--</DELETED>
<DELETED> (1) in clause (v), by striking ``; or'' and
inserting a semicolon;</DELETED>
<DELETED> (2) in clause (vi)--</DELETED>
<DELETED> (A) by striking ``addition'' and inserting
``the addition''; and</DELETED>
<DELETED> (B) by striking the period and inserting
``; or''; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(vii) the addition or modification of a
testing procedure applicable to one or more OTC
monograph drugs, provided that such additional or
modified testing procedure reflects a voluntary
consensus standard with respect to pharmaceutical
quality that is--</DELETED>
<DELETED> ``(I) established by a national or
international standards development
organization; and</DELETED>
<DELETED> ``(II) recognized by the Secretary
through a process described in guidance for
industry, initially published in July 2023, or
any successor guidance, publicly available on
the website of the Food and Drug
Administration, which addresses voluntary
consensus standards for pharmaceutical
quality.''.</DELETED>
<DELETED>SEC. 4. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH
FEES.</DELETED>
<DELETED> (a) Types of Fees.--Section 744M(a)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72(a)(1)) is amended--
</DELETED>
<DELETED> (1) in subparagraph (A)--</DELETED>
<DELETED> (A) by striking ``on December 31 of the
fiscal year or at any time during the preceding 12-
month period'' and inserting ``at any time during the
applicable period specified in clause (ii) for a fiscal
year'';</DELETED>
<DELETED> (B) by striking ``Each person'' and
inserting the following:</DELETED>
<DELETED> ``(i) Assessment of fees.--Each
person''; and</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(ii) Applicable period.--For
purposes of clause (i), the applicable period
is--</DELETED>
<DELETED> ``(I) for fiscal year
2026, the 12-month period ending on
December 31, 2025;</DELETED>
<DELETED> ``(II) for fiscal year
2027, the 9-month period ending on
September 30, 2026; and</DELETED>
<DELETED> ``(III) for fiscal year
2028 and each subsequent fiscal year,
the 12-month period ending on September
30 of the preceding fiscal
year.'';</DELETED>
<DELETED> (2) in subparagraph (B)(i), by amending subclause
(I) to read as follows:</DELETED>
<DELETED> ``(I) has ceased all
activities related to OTC monograph
drugs prior to--</DELETED>
<DELETED> ``(aa) for
purposes of fiscal year 2026,
January 1, 2025;</DELETED>
<DELETED> ``(bb) for
purposes of fiscal year 2027,
January 1, 2026; and</DELETED>
<DELETED> ``(cc) for
purposes of fiscal year 2028
and each subsequent fiscal
year, October 1 of the
preceding fiscal year; and'';
and</DELETED>
<DELETED> (3) by amending subparagraph (D) to read as
follows:</DELETED>
<DELETED> ``(D) Due date.--</DELETED>
<DELETED> ``(i) Fiscal year 2026.--For
fiscal year 2026, the facility fees required
under subparagraph (A) shall be due on the
later of--</DELETED>
<DELETED> ``(I) the first business
day of June of such year; or</DELETED>
<DELETED> ``(II) the first business
day after the enactment of an
appropriations Act providing for the
collection and obligation of fees under
this section for such year.</DELETED>
<DELETED> ``(ii) Fiscal year 2027.--For
fiscal year 2027, the facility fees required
under subparagraph (A) shall be due--</DELETED>
<DELETED> ``(I) in a first
installment representing 50 percent of
such fee, on the later of--</DELETED>
<DELETED> ``(aa) October 1,
2026; or</DELETED>
<DELETED> ``(bb) the first
business day after the
enactment of an appropriations
Act providing for the
collection and obligation of
fees under this section for
such year; and</DELETED>
<DELETED> ``(II) in a second
installment representing the remaining
50 percent of such fee, on--</DELETED>
<DELETED> ``(aa) February 1,
2027; or</DELETED>
<DELETED> ``(bb) if an
appropriations Act described in
subclause (I)(bb) is not in
effect on February 1, 2027, the
first business day after
enactment of such an
appropriations Act.</DELETED>
<DELETED> ``(iii) Subsequent fiscal years.--
For fiscal year 2028 and each subsequent fiscal
year, the facility fees required under
subparagraph (A) shall be due on the later of--
</DELETED>
<DELETED> ``(I) the first business
day on or after October 1 of the fiscal
year; or</DELETED>
<DELETED> ``(II) the first business
day after the date of enactment of an
appropriations Act providing for the
collection and obligation of fees under
this section for the fiscal
year.''.</DELETED>
<DELETED> (b) Fee Revenue Amounts.--Section 744M(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72(b)) is amended to read
as follows:</DELETED>
<DELETED> ``(b) Fee Revenue Amounts.--</DELETED>
<DELETED> ``(1) In general.--For each of the fiscal years
2026 through 2030, fees under subsection (a)(1) shall be
established to generate a total facility fee revenue amount
equal to the sum of--</DELETED>
<DELETED> ``(A) the annual base revenue for the
fiscal year (as determined under paragraph
(2));</DELETED>
<DELETED> ``(B) the dollar amount equal to the
inflation adjustment for the fiscal year (as determined
under subsection (c)(1));</DELETED>
<DELETED> ``(C) the dollar amount equal to the
operating reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(2));</DELETED>
<DELETED> ``(D) additional direct cost adjustments
(as determined under subsection (c)(3));</DELETED>
<DELETED> ``(E) an additional dollar amount equal
to--</DELETED>
<DELETED> ``(i) $2,373,000 for fiscal year
2026;</DELETED>
<DELETED> ``(ii) $1,233,000 for fiscal year
2027; and</DELETED>
<DELETED> ``(iii) $854,000 for fiscal year
2028; and</DELETED>
<DELETED> ``(F) in the case of a fiscal year for
which the Secretary applies the one-time facility fee
workload adjustment under subsection (c)(4), the dollar
amount equal to such adjustment.</DELETED>
<DELETED> ``(2) Annual base revenue.--For purposes of
paragraph (1), the dollar amount of the annual base revenue for
a fiscal year shall be--</DELETED>
<DELETED> ``(A) for fiscal year 2026, the dollar
amount of the total revenue amount established for
fiscal year 2025 under this subsection as in effect on
the day before the date of enactment of the Over-the-
Counter Monograph Drug User Fee Amendments, not
including any adjustments made for such fiscal year
2025 under subsection (c)(2), as so in effect;
and</DELETED>
<DELETED> ``(B) for fiscal years 2027 through 2030,
the dollar amount of the total revenue amount
established under this subsection for the previous
fiscal year, not including any adjustments made for
such previous fiscal year under subsection (c)(2) or
(c)(3).''.</DELETED>
<DELETED> (c) Adjustments; Annual Fee Setting.--Section 744M(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72) is
amended--</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in subparagraph (A), in the matter
preceding clause (i)--</DELETED>
<DELETED> (i) by striking ``subsection
(b)(2)(B)'' and inserting ``subsection
(b)(1)(B)''; and</DELETED>
<DELETED> (ii) by striking ``fiscal year
2022 and each subsequent fiscal year'' and
inserting ``each fiscal year'';</DELETED>
<DELETED> (B) in subparagraph (B), by striking
``fiscal year 2022'' and all that follows through the
period at the end and inserting the following: ``a
fiscal year shall be equal to the product of--
</DELETED>
<DELETED> ``(i) for fiscal year 2026--
</DELETED>
<DELETED> ``(I) the fee for fiscal
year 2025 under subsection (a)(2);
and</DELETED>
<DELETED> ``(II) the inflation
adjustment percentage under
subparagraph (C); and</DELETED>
<DELETED> ``(ii) for each of fiscal years
2027 through 2030--</DELETED>
<DELETED> ``(I) the applicable fee
under subsection (a)(2) for the
preceding fiscal year; and</DELETED>
<DELETED> ``(II) the inflation
adjustment percentage under
subparagraph (C).''; and</DELETED>
<DELETED> (C) in subparagraph (C)--</DELETED>
<DELETED> (i) in the matter preceding clause
(i), by inserting ``the sum of'' after ``is
equal to'';</DELETED>
<DELETED> (ii) by striking clause
(i);</DELETED>
<DELETED> (iii) by redesignating subclauses
(I) and (II) of clause (ii) as clauses (i) and
(ii), respectively, and adjusting the margins
accordingly;</DELETED>
<DELETED> (iv) by striking ``(ii) for each
of fiscal years 2024 and 2025, the sum of--'';
and</DELETED>
<DELETED> (v) in clause (ii), as so
redesignated, by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting
``Washington-Arlington-Alexandria-DC-VA-MD-
WV'';</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) in subparagraph (A)--</DELETED>
<DELETED> (i) by striking ``fiscal year 2021
and subsequent fiscal years'' and inserting
``each fiscal year'';</DELETED>
<DELETED> (ii) by striking ``subsections
(b)(1)(B) and (b)(2)(C)'' and inserting
``subsection (b)(1)(C)''; and</DELETED>
<DELETED> (iii) by striking ``the number of
weeks specified in subparagraph (B)'' and
inserting ``10 weeks'';</DELETED>
<DELETED> (B) by striking subparagraph
(B);</DELETED>
<DELETED> (C) by redesignating subparagraphs (C) and
(D) as subparagraphs (B) and (C), respectively;
and</DELETED>
<DELETED> (D) in subparagraph (C), as so
redesignated, by striking ``paragraph (4)
establishing'' and inserting ``paragraph (5)
publishing'';</DELETED>
<DELETED> (3) in paragraph (3)--</DELETED>
<DELETED> (A) in the matter preceding subparagraph
(A), by striking ``subsection (b)(2)(D)'' and inserting
``subsection (b)(1)(D)''; and</DELETED>
<DELETED> (B) by striking subparagraphs (A) through
(E) and inserting the following:</DELETED>
<DELETED> ``(A) $135,000 for fiscal year
2026;</DELETED>
<DELETED> ``(B) $300,000 for fiscal year
2027;</DELETED>
<DELETED> ``(C) $55,000 for fiscal year
2028;</DELETED>
<DELETED> ``(D) $30,000 for fiscal year 2029;
and</DELETED>
<DELETED> ``(E) $0 for fiscal year 2030.'';
and</DELETED>
<DELETED> (4) by striking paragraph (4) and inserting the
following:</DELETED>
<DELETED> ``(4) One-time facility fee workload adjustment.--
</DELETED>
<DELETED> ``(A) In general.--In addition to the
adjustments under paragraphs (1), (2), and (3), the
Secretary may further increase the fee revenues and
fees through a one-time adjustment made for fiscal year
2028, 2029, or 2030, in accordance with this
paragraph.</DELETED>
<DELETED> ``(B) Adjustment described.--</DELETED>
<DELETED> ``(i) Conditions for adjustment.--
An adjustment under this paragraph may be made
for a fiscal year only if--</DELETED>
<DELETED> ``(I) an adjustment under
this paragraph had not been made for
any prior fiscal year;</DELETED>
<DELETED> ``(II) the average number
of OTC monograph drug facilities
subject to a facility fee under
subsection (a)(1) over the period of
the preceding 3 fiscal years exceeds
1,625; and</DELETED>
<DELETED> ``(III) with respect to
facilities described in subclause (II),
the average number of such facilities
(expressed as a percentage) that
appeared on the arrears lists pursuant
to subsection (e)(1)(A)(i) over the
period of the preceding 3 fiscal years
is less than 30 percent.</DELETED>
<DELETED> ``(ii) Amount of adjustment.--An
adjustment under this paragraph for a fiscal
year shall equal the product of--</DELETED>
<DELETED> ``(I) the total facility
revenue amount determined under
subsection (b) for the fiscal year,
exclusive of the adjustment under this
paragraph for such fiscal year;
and</DELETED>
<DELETED> ``(II) the excess facility
percentage described in clause
(iii).</DELETED>
<DELETED> ``(iii) Excess facility
percentage.--The excess facility percentage
described in this clause is--</DELETED>
<DELETED> ``(I) the amount by which
the average number of OTC monograph
drug facilities subject to a facility
fee under subsection (a)(1) over the
preceding 3 fiscal years exceeds 1,625;
divided by</DELETED>
<DELETED> ``(II) 1,625.</DELETED>
<DELETED> ``(5) Annual fee setting.--The Secretary shall,
not later than 60 days before the first day of each fiscal
year--</DELETED>
<DELETED> ``(A) establish for such fiscal year,
based on the revenue amounts under subsection (b) and
the adjustments provided under this subsection--
</DELETED>
<DELETED> ``(i) OTC monograph drug facility
fees under subsection (a)(1); and</DELETED>
<DELETED> ``(ii) OTC monograph order request
fees under subsection (a)(2); and</DELETED>
<DELETED> ``(B) publish such fee revenue amounts,
facility fees, and OTC monograph order request fees in
the Federal Register.''.</DELETED>
<DELETED> (d) Crediting and Availability of Fees.--Section 744M(f)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72(f)) is
amended--</DELETED>
<DELETED> (1) in paragraph (2)(D)--</DELETED>
<DELETED> (A) in the subparagraph heading, by
striking ``in subsequent years''; and</DELETED>
<DELETED> (B) by striking ``(after fiscal year
2021)''; and</DELETED>
<DELETED> (2) in paragraph (3), by striking ``2021 through
2025'' and inserting ``2026 through 2030''.</DELETED>
<DELETED>SEC. 5. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>
<DELETED> Section 744N of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-73) is amended--</DELETED>
<DELETED> (1) in subsection (a)--</DELETED>
<DELETED> (A) by striking ``Beginning with fiscal
year 2021, and not later than 120 calendar days after
the end of each fiscal year thereafter'' and inserting
``Not later than 120 calendar days after the end of
each fiscal year''; and</DELETED>
<DELETED> (B) by striking ``section 3861(b) of the
CARES Act'' and inserting ``section 2 of the Over-the-
Counter Monograph Drug User Fee Amendments'';</DELETED>
<DELETED> (2) in subsection (b), by striking ``fiscal year
2021 and each subsequent fiscal year'' and inserting ``each
fiscal year''; and</DELETED>
<DELETED> (3) in subsection (d), by striking ``2025'' each
place it appears and inserting ``2030''.</DELETED>
<DELETED>SEC. 6. SUNSET DATES.</DELETED>
<DELETED> (a) Authorization.--Sections 744L and 744M of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-71; 379j-72) shall cease
to be effective October 1, 2030.</DELETED>
<DELETED> (b) Reporting Requirements.--Section 744N of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-73) shall cease to be
effective January 31, 2031.</DELETED>
<DELETED>SEC. 7. EFFECTIVE DATE.</DELETED>
<DELETED> The amendments made by this Act shall take effect on
October 1, 2025, or the date of the enactment of this Act, whichever is
later, except that fees under part 10 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-71 et seq.)
shall be assessed beginning October 1, 2025, regardless of the date of
the enactment of this Act.</DELETED>
<DELETED>SEC. 8. SAVINGS CLAUSE.</DELETED>
<DELETED> Notwithstanding the amendments made by this Act, part 10
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-71 et seq.), as in effect on the day before the
date of enactment of this Act, shall continue to be in effect with
respect to assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2026.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Over-the-Counter Monograph Drug User
Fee Amendments''.
SEC. 2. FINDING.
Congress finds that the fees authorized by the amendments made in
this Act will be dedicated to OTC monograph drug activities, as set
forth in the goals identified for purposes of part 10 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-71 et seq.) in the letters from the Secretary of Health and Human
Services to the Chairman of the Committee on Energy and Commerce of the
House of Representatives and the Chairman of the Committee on Health,
Education, Labor, and Pensions of the Senate, as set forth in the
Congressional Record.
SEC. 3. DEFINITIONS.
Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-71(9)(A)) is amended--
(1) in clause (v), by striking ``; or'' and inserting a
semicolon;
(2) in clause (vi)--
(A) by striking ``addition'' and inserting ``the
addition''; and
(B) by striking the period and inserting ``; or'';
and
(3) by adding at the end the following:
``(vii) the addition or modification of a testing
procedure applicable to one or more OTC monograph
drugs, provided that such additional or modified
testing procedure reflects a voluntary consensus
standard with respect to pharmaceutical quality that
is--
``(I) established by a national or
international standards development
organization; and
``(II) recognized by the Secretary through
a process described in guidance for industry,
initially published in July 2023, or any
successor guidance, publicly available on the
website of the Food and Drug Administration,
which addresses voluntary consensus standards
for pharmaceutical quality.''.
SEC. 4. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.
(a) Types of Fees.--Section 744M(a)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-72(a)(1)) is amended--
(1) in subparagraph (A)--
(A) by striking ``on December 31 of the fiscal year
or at any time during the preceding 12-month period''
and inserting ``at any time during the applicable
period specified in clause (ii) for a fiscal year'';
(B) by striking ``Each person'' and inserting the
following:
``(i) Assessment of fees.--Each person'';
and
(C) by adding at the end the following:
``(ii) Applicable period.--For purposes of
clause (i), the applicable period is--
``(I) for fiscal year 2026, the 12-
month period ending on December 31,
2025;
``(II) for fiscal year 2027, the 9-
month period ending on September 30,
2026; and
``(III) for fiscal year 2028 and
each subsequent fiscal year, the 12-
month period ending on September 30 of
the preceding fiscal year.'';
(2) in subparagraph (B)(i), by amending subclause (I) to
read as follows:
``(I) has ceased all activities
related to OTC monograph drugs prior
to--
``(aa) for purposes of
fiscal year 2026, January 1,
2025;
``(bb) for purposes of
fiscal year 2027, January 1,
2026; and
``(cc) for purposes of
fiscal year 2028 and each
subsequent fiscal year, October
1 of the preceding fiscal year;
and''; and
(3) by amending subparagraph (D) to read as follows:
``(D) Due date.--
``(i) Fiscal year 2026.--For fiscal year
2026, the facility fees required under
subparagraph (A) shall be due on the later of--
``(I) the first business day of
June of such year; or
``(II) the first business day after
the enactment of an appropriations Act
providing for the collection and
obligation of fees under this section
for such year.
``(ii) Fiscal year 2027.--For fiscal year
2027, the facility fees required under
subparagraph (A) shall be due--
``(I) in a first installment
representing 50 percent of such fee, on
the later of--
``(aa) October 1, 2026; or
``(bb) the first business
day after the enactment of an
appropriations Act providing
for the collection and
obligation of fees under this
section for such year; and
``(II) in a second installment
representing the remaining 50 percent
of such fee, on--
``(aa) February 1, 2027; or
``(bb) if an appropriations
Act described in subclause
(I)(bb) is not in effect on
February 1, 2027, the first
business day after enactment of
such an appropriations Act.
``(iii) Subsequent fiscal years.--For
fiscal year 2028 and each subsequent fiscal
year, the facility fees required under
subparagraph (A) shall be due on the later of--
``(I) the first business day on or
after October 1 of the fiscal year; or
``(II) the first business day after
the date of enactment of an
appropriations Act providing for the
collection and obligation of fees under
this section for the fiscal year.''.
(b) Fee Revenue Amounts.--Section 744M(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-72(b)) is amended to read as
follows:
``(b) Fee Revenue Amounts.--
``(1) In general.--For each of the fiscal years 2026
through 2030, fees under subsection (a)(1) shall be established
to generate a total facility fee revenue amount equal to the
sum of--
``(A) the annual base revenue for the fiscal year
(as determined under paragraph (2));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(2));
``(D) additional direct cost adjustments (as
determined under subsection (c)(3));
``(E) an additional dollar amount equal to--
``(i) $2,373,000 for fiscal year 2026;
``(ii) $1,233,000 for fiscal year 2027; and
``(iii) $854,000 for fiscal year 2028; and
``(F) in the case of a fiscal year for which the
Secretary applies the one-time facility fee workload
adjustment under subsection (c)(4), the dollar amount
equal to such adjustment.
``(2) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal year
shall be--
``(A) for fiscal year 2026, the dollar amount of
the total revenue amount established for fiscal year
2025 under this subsection as in effect on the day
before the date of enactment of the Over-the-Counter
Monograph Drug User Fee Amendments, not including any
adjustments made for such fiscal year 2025 under
subsection (c)(2), as so in effect; and
``(B) for fiscal years 2027 through 2030, the
dollar amount of the total revenue amount established
under this subsection for the previous fiscal year, not
including any adjustments made for such previous fiscal
year under subsection (c)(2) or (c)(3).''.
(c) Adjustments; Annual Fee Setting.--Section 744M(c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), in the matter preceding
clause (i)--
(i) by striking ``subsection (b)(2)(B)''
and inserting ``subsection (b)(1)(B)''; and
(ii) by striking ``fiscal year 2022 and
each subsequent fiscal year'' and inserting
``each fiscal year'';
(B) in subparagraph (B), by striking ``fiscal year
2022'' and all that follows through the period at the
end and inserting the following: ``a fiscal year shall
be equal to the product of--
``(i) for fiscal year 2026--
``(I) the fee for fiscal year 2025
under subsection (a)(2); and
``(II) the inflation adjustment
percentage under subparagraph (C); and
``(ii) for each of fiscal years 2027
through 2030--
``(I) the applicable fee under
subsection (a)(2) for the preceding
fiscal year; and
``(II) the inflation adjustment
percentage under subparagraph (C).'';
and
(C) in subparagraph (C)--
(i) in the matter preceding clause (i), by
inserting ``the sum of'' after ``is equal to'';
(ii) by striking clause (i);
(iii) by redesignating subclauses (I) and
(II) of clause (ii) as clauses (i) and (ii),
respectively, and adjusting the margins
accordingly;
(iv) by striking ``(ii) for each of fiscal
years 2024 and 2025, the sum of--''; and
(v) in clause (ii), as so redesignated, by
striking ``Washington-Baltimore, DC-MD-VA-WV''
and inserting ``Washington-Arlington-
Alexandria-DC-VA-MD-WV'';
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) by striking ``fiscal year 2021 and
subsequent fiscal years'' and inserting ``each
fiscal year'';
(ii) by striking ``subsections (b)(1)(B)
and (b)(2)(C)'' and inserting ``subsection
(b)(1)(C)''; and
(iii) by striking ``the number of weeks
specified in subparagraph (B)'' and inserting
``10 weeks'';
(B) by striking subparagraph (B);
(C) by redesignating subparagraphs (C) and (D) as
subparagraphs (B) and (C), respectively; and
(D) in subparagraph (C), as so redesignated, by
striking ``paragraph (4) establishing'' and inserting
``paragraph (5) publishing'';
(3) in paragraph (3)--
(A) in the matter preceding subparagraph (A), by
striking ``subsection (b)(2)(D)'' and inserting
``subsection (b)(1)(D)''; and
(B) by striking subparagraphs (A) through (E) and
inserting the following:
``(A) $135,000 for fiscal year 2026;
``(B) $300,000 for fiscal year 2027;
``(C) $55,000 for fiscal year 2028;
``(D) $30,000 for fiscal year 2029; and
``(E) $0 for fiscal year 2030.''; and
(4) by striking paragraph (4) and inserting the following:
``(4) One-time facility fee workload adjustment.--
``(A) In general.--In addition to the adjustments
under paragraphs (1), (2), and (3), the Secretary may
further increase the fee revenues and fees through a
one-time adjustment made for fiscal year 2028, 2029, or
2030, in accordance with this paragraph.
``(B) Adjustment described.--
``(i) Conditions for adjustment.--An
adjustment under this paragraph may be made for
a fiscal year only if--
``(I) an adjustment under this
paragraph had not been made for any
prior fiscal year;
``(II) the average number of OTC
monograph drug facilities subject to a
facility fee under subsection (a)(1)
over the period of the preceding 3
fiscal years exceeds 1,625; and
``(III) with respect to facilities
described in subclause (II), the
average number of such facilities
(expressed as a percentage) that
appeared on the arrears lists pursuant
to subsection (e)(1)(A)(i) over the
period of the preceding 3 fiscal years
is less than 30 percent.
``(ii) Amount of adjustment.--An adjustment
under this paragraph for a fiscal year shall
equal the product of--
``(I) the total facility revenue
amount determined under subsection (b)
for the fiscal year, exclusive of the
adjustment under this paragraph for
such fiscal year; and
``(II) the excess facility
percentage described in clause (iii).
``(iii) Excess facility percentage.--The
excess facility percentage described in this
clause is--
``(I) the amount by which the
average number of OTC monograph drug
facilities subject to a facility fee
under subsection (a)(1) over the
preceding 3 fiscal years exceeds 1,625;
divided by
``(II) 1,625.
``(5) Annual fee setting.--The Secretary shall, not later
than 60 days before the first day of each fiscal year--
``(A) establish for such fiscal year, based on the
revenue amounts under subsection (b) and the
adjustments provided under this subsection--
``(i) OTC monograph drug facility fees
under subsection (a)(1); and
``(ii) OTC monograph order request fees
under subsection (a)(2); and
``(B) publish such fee revenue amounts, facility
fees, and OTC monograph order request fees in the
Federal Register.''.
(d) Crediting and Availability of Fees.--Section 744M(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72(f)) is
amended--
(1) in paragraph (2)(D)--
(A) in the subparagraph heading, by striking ``in
subsequent years''; and
(B) by striking ``(after fiscal year 2021)''; and
(2) in paragraph (3), by striking ``2021 through 2025'' and
inserting ``2026 through 2030''.
SEC. 5. REAUTHORIZATION; REPORTING REQUIREMENTS.
(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 fiscal year 2021,
and not later than 120 calendar days after the end of
each fiscal year thereafter'' and inserting the
following:
``(1) In general.--Not later than 120 calendar days after
the end of each fiscal year'';
(B) by striking ``section 3861(b) of the CARES
Act'' and inserting ``section 2 of the Over-the-Counter
Monograph Drug User Fee Amendments''; 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;
``(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;
``(C) the status of implementation of evidence and
testing standards for nonprescription drugs intended
for topical administration, including--
``(i) the application of evidence or
testing standards; and
``(ii) the number of active ingredient
requests for nonprescription drugs intended for
topical administration reviewed using the
standards under section 505G(b); and
``(D) the progress of the Food and Drug
Administration in allowing nonclinical testing
alternatives to animal testing for the consideration of
sunscreen active ingredients.
``(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.'';
(2) in subsection (b), by striking ``fiscal year 2021 and
each subsequent fiscal year'' and inserting ``each fiscal
year''; and
(3) in subsection (d)--
(A) by striking ``2025'' each place it appears and
inserting ``2030''; and
(B) by adding at the end 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 September 30, 2027, 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) 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 the Food and Drug
Administration may need to ensure the stability of the
supply chain of over-the-counter monograph drugs.
SEC. 6. TREATMENT OF ACTIVE INGREDIENTS FOR TOPICAL ADMINISTRATION.
(a) In General.--Section 505G of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355h) is amended by adding at the end the
following:
``(r) Evidence and Testing Standards for Active Ingredients for
Topical Administration.--
``(1) Evidence and testing standards for active ingredients
for topical administration.--The Secretary shall--
``(A) in evaluating the generally recognized as
safe and effective status of active ingredients used in
nonprescription drugs intended for topical
administration for purposes of subsection (a), utilize
standards that allow for the use of real world evidence
(as defined in section 505F(b)), as appropriate, as
part of a comprehensive evaluation of scientific
evidence to demonstrate the safety and effectiveness of
such active ingredients, to supplement evidence from
traditional clinical trials, provided that such
standards allow the Secretary to evaluate whether the
benefits of such active ingredients outweigh the risks;
and
``(B) apply subsection (b)(6)(C) to the regulation
of active ingredients used in drugs intended for
topical administration.
``(2) Non-animal testing methods for topical active
ingredients.--
``(A) In general.--The Secretary shall consider the
types of nonclinical tests described in paragraphs (1)
through (4) of the first subsection (z) of section 505
(as inserted by section 3209(a)(2) of the Health
Extenders, Improving Access to Medicare, Medicaid, and
CHIP, and Strengthening Public Health Act of 2022
(division FF of Public Law 117-328)), or any other
alternative to animal testing that the Secretary
determines appropriate, in the consideration of drugs
intended for topical administration under this section.
``(B) Guidance.--Not later than 1 year after the
date of enactment of this subsection, the Secretary
shall issue new draft guidance on how sponsors can use
nonclinical testing alternatives to animal testing, as
appropriate, to meet safety and efficacy standards
under this section for drugs intended for topical
administration.
``(3) Clarification.--Nothing in this subsection shall be
construed to alter, supersede, or limit the standards for
making determinations of whether a drug is generally recognized
as safe and effective under section 201(p) or the standards set
forth under section 505 for determining the safety and
effectiveness of drugs.''.
(b) Sunscreen Final Administrative Order.--A final administrative
order on nonprescription sunscreen active ingredients issued under
section 3854 of the Coronavirus Aid, Relief, and Economic Security Act
(Public Law 116-136; 21 U.S.C. 360fff-3 note) shall--
(1) account for historical data regarding the safety of
sunscreen active ingredients that have previously been accepted
for marketing in the United States;
(2) account for the role of broad spectrum sunscreens with
a Sun Protection Factor of 15 or higher in effective skin
cancer prevention; and
(3) incorporate the evidence and testing standards for
sunscreen active ingredients detailed in section 505G(r) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (as added
by subsection (a)).
SEC. 7. INCREASING THE CLARITY AND PREDICTABILITY OF THE PROCESS FOR
DEVELOPING APPLICATIONS FOR RX-TO-NONPRESCRIPTION
SWITCHES.
(a) In General.--Section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the end the
following:
``(7) Rx-to-nonprescription switches.--
``(A) Meetings.--Any person planning to submit an
application for an Rx-to-nonprescription switch may
submit to the Secretary a written request for a
meeting, for purposes of developing a plan for such
application that addresses the potential risks to
public health of such switch and the evidence necessary
to support such application, including the design of
any necessary studies, and the format and content of
the planned application. The Secretary may grant such a
meeting, as appropriate, consistent with established
procedures for granting meetings with, and providing
written responses to, sponsors of applications under
this section. Each such meeting shall be documented in
meeting minutes.
``(B) Guidance.--
``(i) In general.--Not later than 18 months
after the date of enactment of this paragraph,
the Secretary shall issue guidance to increase
the clarity and predictability of the process
and standards for approval of applications for
nonprescription drugs under this section,
including in the case of applications for an
Rx-to-nonprescription switch, especially with
respect to prescription drugs with well-
established safety profiles for which an
applicant may seek approval for nonprescription
use.
``(ii) Contents.--The guidance under clause
(i) shall--
``(I) describe how published
reports in medical literature, any
previous finding of safety or
effectiveness for the drug under this
section, the results of significant
human experience with the drug,
unpublished studies and other data, and
other sources of information may be
used to support an application for a
nonprescription drug, including in the
context of an application for an Rx-to-
nonprescription switch;
``(II) set forth procedures for
sponsors to request meetings described
in subparagraph (A) and document the
recommendations made in such meetings;
``(III) describe evidentiary
expectations to support approval of an
application for a nonprescription drug,
including in the context of an
application for an Rx-to-
nonprescription switch, including how
sponsors can demonstrate that consumers
can appropriately self-select and use
the drug and comprehend the
nonprescription drug label; and
``(IV) provide recommendations for
how mechanisms, in addition to the
required Drug Facts Label, such as
mobile applications and decision aids,
can be incorporated into the
information submitted in support of an
application for an Rx-to-
nonprescription switch.
``(C) Plan to engage with stakeholders.--Not later
than 1 year after the date of enactment of this
paragraph, the Secretary shall develop and make
publicly available on the website of the Food and Drug
Administration a plan to engage stakeholders on steps
and factors for application holders and other
stakeholders to consider in identifying approved
prescription drugs that may be promising candidates for
applications for an Rx-to-nonprescription switch.
``(D) Definition.--The term `Rx-to-nonprescription
switch' means the approval of an application, or
supplemental application, as applicable, submitted
under this section by the holder of an approved
application for a prescription drug seeking approval to
market such drug as a nonprescription drug, including
for--
``(i) a full Rx-to-nonprescription switch,
under which a drug previously approved for
prescription use only is--
``(I) approved for nonprescription
use under the same conditions of use as
applied to the drug when approved for
prescription use; or
``(II) approved for nonprescription
use subject to one or more additional
conditions for nonprescription use; and
``(ii) a partial Rx-to-nonprescription
switch, under which the drug is approved for
nonprescription use only under certain
conditions of use described in the approved
labeling, while the drug otherwise remains
approved for prescription use only.
``(E) Rule of construction.--Nothing in this
paragraph shall be construed to--
``(i) supersede or modify the authority of
the Secretary under section 505G with respect
to the regulation of OTC monograph drugs; or
``(ii) authorize the disclosure by the
Secretary of confidential commercial
information or trade secrets.''.
(b) GAO Report.--
(1) In general.--Not later than 1 year 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 that
evaluates--
(A) the number of applications for an Rx-to-
nonprescription switch approved during the period
beginning on October 1, 2022, and ending on the date of
the report;
(B) the number of drugs for which an application
for an Rx-to-nonprescription switch was approved during
such period subject to an additional condition for
nonprescription use;
(C) among the drugs for which an application for a
full or partial Rx-to-nonprescription switch was
approved during such period, the average length of time
from receipt by the Food and Drug Administration of the
application to the approval of such application;
(D) the number of partial Rx-to-nonprescription
switch applications approved during such period, and
the number of applications for such a partial switch
was not approved;
(E) any barriers to timely and predictable review
of applications for an Rx-to-nonprescription switch;
(F) engagement by the Food and Drug Administration
with public stakeholders, including public meetings or
additional activities, to support review of
applications for an Rx-to-nonprescription switch; and
(G) opportunities for collaboration between the
Center for Drug Evaluation and Research and the Centers
for Medicare & Medicaid Services for the purpose of
analyzing health insurance claims data for commonly
prescribed drugs that appear to be suitable for an Rx-
to-nonprescription switch.
(2) Definition.--In this subsection, the term ``Rx-to-
nonprescription switch'' has the meaning given such term in
paragraph (7) of section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 244(b)), as added by subsection (a).
SEC. 8. SUNSET DATES.
(a) Authorization.--Sections 744L and 744M of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-71; 379j-72) shall cease to be
effective October 1, 2030.
(b) Reporting Requirements.--Section 744N of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-73) shall cease to be effective
January 31, 2031.
SEC. 9. EFFECTIVE DATE.
The amendments made by this Act shall take effect on October 1,
2025, or the date of the enactment of this Act, whichever is later,
except that fees under part 10 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-71 et seq.) shall
be assessed beginning October 1, 2025, regardless of the date of the
enactment of this Act.
SEC. 10. SAVINGS CLAUSE.
Notwithstanding the amendments made by this Act, part 10 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-71 et seq.), as in effect on the day before the date of
enactment of this Act, shall continue to be in effect with respect to
assessing and collecting any fee required by such part for a fiscal
year prior to fiscal year 2026.
Calendar No. 152
119th CONGRESS
1st Session
S. 2292
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user fee program for over-the-counter monograph drugs, and for
other purposes.
_______________________________________________________________________
September 8, 2025
Reported with an amendment