Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Give Kids a Chance Act of 2025’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Research into pediatric uses of drugs; additional authorities of Food and 
Drug Administration regarding molecularly targeted cancer 
drugs. 
Sec. 3. Ensuring completion of pediatric study requirements. 
Sec. 4. FDA report on PREA enforcement. 
Sec. 5. Extension of authority to issue priority review vouchers to encourage 
treatments for rare pediatric diseases. 
Sec. 6. Limitations on exclusive approval or licensure of orphan drugs. 
Sec. 7. Program for pediatric studies of drugs. 
Sec. 8. Organ Procurement and Transplantation Network. 
Sec. 9. Establishment of Abraham Accords Office within Food and Drug Admin-
istration. 
Sec. 10. Increasing transparency in generic drug applications. 
Sec. 11. Medicare Improvement Fund. 
SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDI-
TIONAL AUTHORITIES OF FOOD AND DRUG 
ADMINISTRATION 
REGARDING 
MOLECU-
LARLY TARGETED CANCER DRUGS. 
(a) IN GENERAL.— 
(1) ADDITIONAL ACTIVE INGREDIENT FOR APPLI-
CATION
DRUG; LIMITATION
REGARDING
NOVEL-COM-
BINATION APPLICATION DRUG.—Section 505B(a)(3) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c(a)(3)) is amended— 
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(A) by redesignating subparagraphs (B) 
and (C) as subparagraphs (C) and (D), respec-
tively; and 
(B) by striking subparagraph (A) and in-
serting the following: 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), the investigation described in this 
paragraph is a molecularly targeted pediatric 
cancer investigation of— 
‘‘(i) the drug or biological product for 
which the application referred to in such 
paragraph is submitted; or 
‘‘(ii) such drug or biological product 
used in combination with— 
‘‘(I) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(j) 
under this Act or under section 
351(k) of the Public Health Serv-
ice Act is in effect; and 
‘‘(bb) that is determined by 
the Secretary, after consultation 
with the applicant, to be part of 
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the standard of care for treating a 
pediatric cancer; or 
‘‘(II) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(b) 
of this Act or section 351(a) of the 
Public Health Service Act to treat 
an adult cancer is in effect and is 
held by the same person submit-
ting the application under para-
graph (1)(B); and 
‘‘(bb) that is directed at a 
molecular target that the Sec-
retary determines to be substan-
tially relevant to the growth or 
progression of a pediatric cancer. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) DESIGN
OF
INVESTIGATION.—A 
molecularly targeted pediatric cancer inves-
tigation referred to in subparagraph (A) 
shall be designed to yield clinically mean-
ingful pediatric study data that is gathered 
using appropriate formulations for each age 
group for which the study is required, re-
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garding dosing, safety, and preliminary ef-
ficacy to inform potential pediatric label-
ing. 
‘‘(ii) LIMITATION.—An investigation 
described in subparagraph (A)(ii) may be 
required only if the drug or biological prod-
uct for which the application referred to in 
paragraph (1)(B) contains either— 
‘‘(I) a single new active ingre-
dient; or 
‘‘(II) more than one active ingre-
dient, if an application for the com-
bination of active ingredients has not 
previously been approved but each ac-
tive ingredient is in a drug product 
that has been previously approved to 
treat an adult cancer. 
‘‘(iii) 
RESULTS
OF
ALREADY-COM-
PLETED PRECLINICAL STUDIES OF APPLICA-
TION DRUG.—With respect to an investiga-
tion 
required 
pursuant 
to 
paragraph 
(1)(B), the Secretary may require the re-
sults of any completed preclinical studies 
relevant to the initial pediatric study plan 
be submitted to the Secretary at the same 
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time that the initial pediatric study plan 
required under subsection (e)(1) is sub-
mitted. 
‘‘(iv) RULE
OF
CONSTRUCTION
RE-
GARDING INACTIVE INGREDIENTS.—With re-
spect to a combination of active ingredients 
referred to in subparagraph (A)(ii), such 
subparagraph shall not be construed as ad-
dressing the use of inactive ingredients with 
such combination.’’. 
(2) DETERMINATION OF APPLICABLE REQUIRE-
MENTS.—Section 505B(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 
amended by adding at the end the following: ‘‘The 
Secretary shall determine whether subparagraph (A) 
or (B) of subsection (a)(1) applies with respect to an 
application before the date on which the applicant is 
required to submit the initial pediatric study plan 
under paragraph (2)(A).’’. 
(3) 
CLARIFYING
APPLICABILITY.—Section 
505B(a)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(a)(1)) is amended by adding at 
the end the following: 
‘‘(C) RULE OF CONSTRUCTION.—No appli-
cation that is subject to the requirements of sub-
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paragraph (B) shall be subject to the require-
ments of subparagraph (A), and no application 
(or supplement to an application) that is subject 
to the requirements of subparagraph (A) shall be 
subject to the requirements of subparagraph 
(B).’’. 
(4) 
CONFORMING
AMENDMENTS.—Section 
505B(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355c(a)) is amended— 
(A) in paragraph (3)(C), as redesignated by 
paragraph (1)(A) of this subsection, by striking 
‘‘investigations described in this paragraph’’ and 
inserting ‘‘investigations referred to in subpara-
graph (A)’’; and 
(B) in paragraph (3)(D), as redesignated 
by paragraph (1)(A) of this subsection, by strik-
ing ‘‘the assessments under paragraph (2)(B)’’ 
and inserting ‘‘the assessments required under 
paragraph (1)(A)’’. 
(b) GUIDANCE.—The Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs, shall— 
(1) not later than 12 months after the date of en-
actment of this Act, issue draft guidance on the im-
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plementation of the amendments made by subsection 
(a); and 
(2) not later than 12 months after closing the 
comment period on such draft guidance, finalize such 
guidance. 
(c) APPLICABILITY.—The amendments made by this 
section apply with respect to any application under section 
505(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)) and any application under section 351(a) 
of the Public Health Service Act (42 U.S.C. 262(a)), that 
is submitted on or after the date that is 3 years after the 
date of enactment of this Act. 
(d) REPORTS TO CONGRESS.— 
(1) SECRETARY OF HEALTH AND HUMAN SERV-
ICES.—Not later than 6 years after the date of enact-
ment of this Act, the Secretary of Health and Human 
Services shall submit to the Committee on Energy 
and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the Secretary’s ef-
forts, in coordination with industry, to ensure imple-
mentation of the amendments made by subsection (a). 
(2) GAO STUDY AND REPORT.— 
(A) STUDY.—Not later than 8 years after 
the date of enactment of this Act, the Comptroller 
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General of the United States shall conduct a 
study of the effectiveness of requiring assessments 
and investigations described in section 505B of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c), as amended by subsection (a), in 
the development of drugs and biological products 
for pediatric cancer indications, including con-
sideration of any benefits to, or burdens on, pe-
diatric cancer drug development. 
(B) FINDINGS.—Not later than 10 years 
after the date of enactment of this Act, the 
Comptroller General shall submit to the Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a 
report containing the findings of the study con-
ducted under subparagraph (A). 
SEC. 3. ENSURING COMPLETION OF PEDIATRIC STUDY RE-
QUIREMENTS. 
(a) EQUAL ACCOUNTABILITY FOR PEDIATRIC STUDY 
REQUIREMENTS.—Section 505B(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amended— 
(1) in paragraph (1), by striking ‘‘Beginning 
270’’ and inserting ‘‘NONCOMPLIANCE LETTER.—Be-
ginning 270’’; 
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(2) in paragraph (2)— 
(A) by striking ‘‘The drug or’’ and inserting 
‘‘EFFECT
OF
NONCOMPLIANCE.—The drug or’’; 
and 
(B) by striking ‘‘(except that the drug or bi-
ological product shall not be subject to action 
under section 303)’’ and inserting ‘‘(except that 
the drug or biological product shall be subject to 
action under section 303 only if such person 
demonstrated a lack of due diligence in satis-
fying the applicable requirement)’’; and 
(3) by adding at the end the following: 
‘‘(3) LIMITATION.—The Secretary shall not issue 
enforcement actions under section 303 for failures 
under this subsection in the case of a drug or biologi-
cal product that is no longer marketed.’’. 
(b) DUE DILIGENCE.—Section 505B(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)), as 
amended by subsection (a), is further amended by adding 
at the end the following: 
‘‘(4) DUE DILIGENCE.—Before the Secretary may 
conclude that a person failed to submit or otherwise 
meet a requirement as described in the matter pre-
ceding paragraph (1), the Secretary shall— 
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‘‘(A) issue a noncompliance letter pursuant 
to paragraph (1); 
‘‘(B) provide such person with a 45-day pe-
riod beginning on the date of receipt of such non-
compliance letter to respond in writing as set 
forth in such paragraph; and 
‘‘(C) after reviewing such written response, 
determine whether the person demonstrated a 
lack of due diligence in satisfying such require-
ment.’’. 
(c) CONFORMING AMENDMENTS.—Section 303(f)(4)(A) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333(f)(4)(A)) is amended by striking ‘‘or 505–1’’ and in-
serting ‘‘505–1, or 505B’’. 
(d) TRANSITION RULE.—The Secretary of Health and 
Human Services may take enforcement action under section 
303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333) only for failures described in section 505B(d) of such 
Act (21 U.S.C. 355c(d)) that occur on or after the date that 
is 180 days after the date of enactment of this Act. 
SEC. 4. FDA REPORT ON PREA ENFORCEMENT. 
Section 508(b) of the Food and Drug Administration 
Safety and Innovation Act (21 U.S.C. 355c–1(b)) is amend-
ed— 
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(1) in paragraph (11), by striking the semicolon 
at the end and inserting ‘‘, including an evaluation 
of compliance with deadlines provided for in deferrals 
and deferral extensions;’’; 
(2) in paragraph (15), by striking ‘‘and’’ at the 
end; 
(3) in paragraph (16), by striking the period at 
the end and inserting ‘‘; and’’; and 
(4) by adding at the end the following: 
‘‘(17) a listing of penalties, settlements, or pay-
ments under section 303 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 353) for failure to com-
ply with requirements under such section 505B, in-
cluding, for each penalty, settlement, or payment, the 
name of the drug, the sponsor thereof, and the amount 
of the penalty, settlement, or payment imposed.’’. 
SEC. 5. EXTENSION OF AUTHORITY TO ISSUE PRIORITY RE-
VIEW VOUCHERS TO ENCOURAGE TREAT-
MENTS FOR RARE PEDIATRIC DISEASES. 
(a) EXTENSION.—Paragraph (5) of section 529(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff(b)) is amended by striking ‘‘December 20, 2024, un-
less’’ and all that follows through the period at the end and 
inserting ‘‘September 30, 2029.’’. 
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(b) USER FEE PAYMENT.—Section 529(c)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff(c)(4)) is amended by striking subparagraph (A) and 
inserting the following: 
‘‘(A) IN
GENERAL.—The priority review 
user fee required by this subsection shall be due 
upon the submission of a human drug applica-
tion under section 505(b)(1) or section 351(a) of 
the Public Health Service Act for which the pri-
ority review voucher is used. All other user fees 
associated with the human drug application 
shall be due as required by the Secretary or 
under applicable law.’’. 
(c) GAO REPORT ON EFFECTIVENESS OF RARE PEDI-
ATRIC
DISEASE
PRIORITY
VOUCHER
AWARDS
IN 
INCENTIVIZING RARE PEDIATRIC DISEASE DRUG DEVEL-
OPMENT.— 
(1) GAO STUDY.— 
(A) STUDY.—The Comptroller General of 
the United States shall conduct a study of the ef-
fectiveness of awarding rare pediatric disease 
priority vouchers under section 529 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff), as amended by subsection (a), in the de-
velopment of human drug products that treat or 
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prevent rare pediatric diseases (as defined in 
such section 529). 
(B) CONTENTS OF STUDY.—In conducting 
the study under subparagraph (A), the Comp-
troller General shall examine the following: 
(i) The indications for each drug or bi-
ological product that— 
(I) is the subject of a rare pedi-
atric disease product application (as 
defined in section 529 of the Federal 
Food, Drug, and Cosmetic Act (21 
U.S.C. 360ff)) for which a priority re-
view voucher was awarded; and 
(II) was approved under section 
505 of the Federal Food, Drug, and 
Cosmetic Act (42 U.S.C. 355) or li-
censed under section 351 of the Public 
Health Service Act (42 U.S.C. 262). 
(ii) Whether, and to what extent, an 
unmet need related to the treatment or pre-
vention of a rare pediatric disease was met 
through the approval or licensure of such a 
drug or biological product. 
(iii) The size of the company to which 
a priority review voucher was awarded 
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under section 529 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360ff) 
for such a drug or biological product. 
(iv) The value of such priority review 
voucher if transferred. 
(v) Identification of each drug for 
which a priority review voucher awarded 
under such section 529 was used. 
(vi) The size of the company using 
each priority review voucher awarded under 
such section 529. 
(vii) The length of the period of time 
between the date on which a priority review 
voucher was awarded under such section 
529 and the date on which it was used. 
(viii) Whether, and to what extent, an 
unmet need related to the treatment or pre-
vention of a rare pediatric disease was met 
through the approval under section 505 of 
the Federal Food, Drug, and Cosmetic Act 
(42 U.S.C. 355) or licensure under section 
351 of the Public Health Service Act (42 
U.S.C. 262) of a drug for which a priority 
review voucher was used. 
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(ix) Whether, and to what extent, com-
panies were motivated by the availability of 
priority review vouchers under section 529 
of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360ff) to attempt to develop 
a drug for a rare pediatric disease. 
(x) Whether, and to what extent, pedi-
atric review vouchers awarded under such 
section were successful in stimulating devel-
opment and expedited patient access to drug 
products for treatment or prevention of a 
rare pediatric disease that wouldn’t other-
wise take place without the incentive pro-
vided by such vouchers. 
(xi) The impact of such priority review 
vouchers on the workload, review process, 
and public health prioritization efforts of 
the Food and Drug Administration. 
(xii) Any other incentives in Federal 
law that exist for companies developing 
drugs or biological products described in 
clause (i). 
(2) REPORT
ON
FINDINGS.—Not later than 5 
years after the date of the enactment of this Act, the 
Comptroller General of the United States shall submit 
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to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate 
a report containing the findings of the study con-
ducted under paragraph (1). 
SEC. 6. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN-
SURE OF ORPHAN DRUGS. 
(a) IN GENERAL.—Section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 
(1) in subsection (a), in the matter following 
paragraph (2), by striking ‘‘same disease or condi-
tion’’ and inserting ‘‘same approved use or indication 
within such rare disease or condition’’; 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘same rare disease or condition’’ and 
inserting ‘‘same approved use or indication for 
which such 7-year period applies to such already 
approved or licensed drug’’; and 
(B) in paragraph (1), by inserting ‘‘, relat-
ing to the approved use or indication,’’ after ‘‘the 
needs’’; 
(3) in subsection (c)(1), by striking ‘‘same rare 
disease or condition as the already approved drug’’ 
and inserting ‘‘same use or indication for which the 
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already approved or licensed drug was approved or 
licensed’’; and 
(4) by adding at the end the following: 
‘‘(f) APPROVED USE OR INDICATION DEFINED.—In 
this section, the term ‘approved use or indication’ means 
the use or indication approved under section 505 of this 
Act or licensed under section 351 of the Public Health Serv-
ice Act for a drug designated under section 526 for a rare 
disease or condition.’’. 
(b) APPLICATION OF AMENDMENTS.—The amendments 
made by subsection (a) shall apply with respect to any drug 
designated under section 526 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bb), regardless of the date 
on which the drug was so designated, and regardless of the 
date on which the drug was approved under section 505 
of such Act (21 U.S.C. 355) or licensed under section 351 
of the Public Health Service Act (42 U.S.C. 262). 
SEC. 7. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 
Section 409I(d)(1) of the Public Health Service Act 
(42 U.S.C. 284m(d)(1)) is amended by striking ‘‘section,’’ 
and all that follows through the period at the end and in-
serting ‘‘section, $25,000,000 for each of fiscal years 2026 
through 2028.’’. 
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SEC. 8. ORGAN PROCUREMENT AND TRANSPLANTATION 
NETWORK. 
Section 372 of the Public Health Service Act (42 
U.S.C. 274) is amended— 
(1) in subsection (b)(2)— 
(A) by moving the margins of subpara-
graphs (M) through (O) 2 ems to the left; 
(B) in subparagraph (A)— 
(i) in clause (i), by striking ‘‘, and’’ 
and inserting ‘‘; and’’; and 
(ii) in clause (ii), by striking the 
comma at the end and inserting a semi-
colon; 
(C) in subparagraph (C), by striking 
‘‘twenty-four-hour telephone service’’ and insert-
ing ‘‘24-hour telephone or information technology 
service’’; 
(D) in each of subparagraphs (B) through 
(M), by striking the comma at the end and in-
serting a semicolon; 
(E) in subparagraph (N), by striking 
‘‘transportation, and’’ and inserting ‘‘transpor-
tation;’’; 
(F) in subparagraph (O), by striking the 
period and inserting a semicolon; and 
(G) by adding at the end the following: 
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‘‘(P) encourage the integration of electronic 
health records systems through application pro-
gramming interfaces (or successor technologies) 
among hospitals, organ procurement organiza-
tions, and transplant centers, including the use 
of automated electronic hospital referrals and the 
grant of remote, electronic access to hospital elec-
tronic health records of potential donors by 
organ procurement organizations, in a manner 
that complies with the privacy regulations pro-
mulgated under the Health Insurance Portability 
and Accountability Act of 1996, at part 160 of 
title 45, Code of Federal Regulations, and sub-
parts A, C, and E of part 164 of such title (or 
any successor regulations); and 
‘‘(Q) consider establishing a dashboard to 
display the number of transplants performed, the 
types of transplants performed, the number and 
types of organs that entered the Organ Procure-
ment and Transplantation Network system and 
failed to be transplanted, and other appropriate 
statistics, which should be updated more fre-
quently than annually.’’; and 
(2) by adding at the end the following: 
‘‘(d) REGISTRATION FEES.— 
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‘‘(1) IN GENERAL.—The Secretary may collect 
registration fees from any member of the Organ Pro-
curement and Transplantation Network for each 
transplant candidate such member places on the list 
described in subsection (b)(2)(A)(i). Such registration 
fees shall be collected and distributed only to support 
the operation of the Organ Procurement and Trans-
plantation Network. Such registration fees are author-
ized to remain available until expended. 
‘‘(2) COLLECTION.—The Secretary may collect 
the registration fees under paragraph (1) directly or 
through awards made under subsection (b)(1)(A). 
‘‘(3) DISTRIBUTION.—Any amounts collected 
under this subsection shall— 
‘‘(A) be credited to the currently applicable 
appropriation, account, or fund of the Depart-
ment of Health and Human Services as discre-
tionary offsetting collections; and 
‘‘(B) be available, only to the extent and in 
the amounts provided in advance in appropria-
tions Acts, to distribute such fees among award-
ees described in subsection (b)(1)(A). 
‘‘(4) TRANSPARENCY.—The Secretary shall— 
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‘‘(A) promptly post on the website of the 
Organ Procurement and Transplantation Net-
work— 
‘‘(i) the amount of registration fees col-
lected under this subsection from each mem-
ber of the Organ Procurement and Trans-
plantation Network; and 
‘‘(ii) a list of activities such fees are 
used to support; and 
‘‘(B) update the information posted pursu-
ant to subparagraph (A), as applicable for each 
calendar quarter for which fees are collected 
under paragraph (1). 
‘‘(5) GAO REVIEW.—Not later than 2 years after 
the date of enactment of this subsection, the Comp-
troller General of the United States shall, to the extent 
data are available— 
‘‘(A) conduct a review concerning the ac-
tivities under this subsection; and 
‘‘(B) submit to the Committee on Health, 
Education, Labor, and Pensions and the Com-
mittee on Finance of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives, a report on such review, includ-
ing related recommendations, as applicable. 
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‘‘(6) SUNSET.—The authority to collect registra-
tion fees under paragraph (1) shall expire on the date 
that is 3 years after the date of enactment of the Give 
Kids a Chance Act of 2025.’’. 
SEC. 9. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE 
WITHIN FOOD AND DRUG ADMINISTRATION. 
(a) IN GENERAL.—Chapter X of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 
‘‘(a) IN GENERAL.—The Secretary, acting through the 
Commissioner of Food and Drugs, shall establish within the 
Food and Drug Administration an office, to be known as 
the Abraham Accords Office, to be headed by a director. 
‘‘(b) OFFICE.—Not later than two years after the date 
of enactment of this section, the Secretary shall— 
‘‘(1) in consultation with the governments of 
Abraham Accords countries, as well as appropriate 
United States Government diplomatic and security 
personnel— 
‘‘(A) select the location of the Abraham Ac-
cords Office in an Abraham Accords country; 
and 
‘‘(B) establish such office; and 
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‘‘(2) assign to such office such personnel of the 
Food and Drug Administration as the Secretary de-
termines necessary to carry out the functions of such 
office. 
‘‘(c) DUTIES.—The Secretary, acting through the Di-
rector of the Abraham Accords Office, shall— 
‘‘(1) after the Abraham Accords Office is estab-
lished— 
‘‘(A) as part of the Food and Drug Admin-
istration’s work to strengthen the international 
oversight of regulated commodities, provide tech-
nical assistance to regulatory partners in Abra-
ham Accords countries on strengthening regu-
latory oversight and converging regulatory re-
quirements for the oversight of regulated prod-
ucts, including good manufacturing practices 
and other issues relevant to manufacturing med-
ical products that are regulated by the Food and 
Drug Administration; and 
‘‘(B) facilitate interactions between the 
Food and Drug Administration and interested 
parties in Abraham Accords countries, including 
by sharing relevant information regarding 
United States regulatory pathways with such 
parties, and facilitate feedback on the research, 
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development, and manufacturing of products reg-
ulated in accordance with this Act; and 
‘‘(2) carry out other functions and activities as 
the Secretary determines to be necessary to carry out 
this section. 
‘‘(d) ABRAHAM ACCORDS COUNTRY DEFINED.—In this 
section, the term ‘Abraham Accords country’ means a coun-
try identified by the Department of State as having signed 
the Abraham Accords Declaration. 
‘‘(e) NATIONAL SECURITY.—Nothing in this section 
shall be construed to require any action inconsistent with 
a national security recommendation provided by the Fed-
eral Government.’’. 
(b) REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit to the Con-
gress a report on the Abraham Accords Office, includ-
ing— 
(A) an evaluation of how the Office has ad-
vanced progress toward conformance with Food 
and Drug Administration regulatory require-
ments by manufacturers in the Abraham Accords 
countries; 
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(B) a numerical count of parties that the 
Office has helped facilitate interactions or feed-
back pursuant to section 1015(c)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act (as added 
by subsection (a)); 
(C) a summary of technical assistance pro-
vided to regulatory partners in Abraham Accords 
countries pursuant to subparagraph (A) of such 
section 1015(c)(1); and 
(D) recommendations for increasing and 
improving coordination between the Food and 
Drug Administration and entities in Abraham 
Accords countries. 
(2) ABRAHAM ACCORDS COUNTRY DEFINED.—In 
this subsection, the term ‘‘Abraham Accords country’’ 
has the meaning given such term in section 1015(d) 
of the Federal Food, Drug, and Cosmetic Act (as 
added by subsection (a)). 
SEC. 10. INCREASING TRANSPARENCY IN GENERIC DRUG 
APPLICATIONS. 
(a) IN GENERAL.—Section 505(j)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 
amended by adding at the end the following: 
‘‘(H)(i) Upon request (in controlled correspondence or 
an analogous process) by a person that has submitted or 
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intends to submit an abbreviated application under this 
subsection for a drug that is required by regulation to con-
tain one or more of the same inactive ingredients in the 
same concentrations as the listed drug referred to, or for 
which the Secretary determines there is a scientific jus-
tification for an approach that is in vitro, in whole or in 
part, to be used to demonstrate bioequivalence for a drug 
if such a drug contains one or more of the same inactive 
ingredients in the same concentrations as the listed drug 
referred to, the Secretary shall inform the person whether 
such drug is qualitatively and quantitatively the same as 
the listed drug. The Secretary may also provide such infor-
mation to such a person on the Secretary’s own initiative 
during the review of an abbreviated application under this 
subsection for such drug. 
‘‘(ii) Notwithstanding section 301(j), if the Secretary 
determines that such drug is not qualitatively or quan-
titatively the same as the listed drug, the Secretary shall 
identify and disclose to the person— 
‘‘(I) the ingredient or ingredients that cause such 
drug not to be qualitatively or quantitatively the 
same as the listed drug; and 
‘‘(II) for any ingredient for which there is an 
identified quantitative deviation, the amount of such 
deviation. 
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‘‘(iii) If the Secretary determines that such drug is 
qualitatively and quantitatively the same as the listed drug, 
the Secretary shall not change or rescind such determina-
tion after the submission of an abbreviated application for 
such drug under this subsection unless— 
‘‘(I) the formulation of the listed drug has been 
changed and the Secretary has determined that the 
prior listed drug formulation was withdrawn for rea-
sons of safety or effectiveness; or 
‘‘(II) the Secretary makes a written determina-
tion that the prior determination must be changed be-
cause an error has been identified. 
‘‘(iv) If the Secretary makes a written determination 
described in clause (iii)(II), the Secretary shall provide no-
tice and a copy of the written determination to the person 
making the request under clause (i). 
‘‘(v) The disclosures authorized under clauses (i) and 
(ii) are disclosures authorized by law, including for pur-
poses of section 1905 of title 18, United States Code. This 
subparagraph shall not otherwise be construed to authorize 
the disclosure of nonpublic qualitative or quantitative infor-
mation about the ingredients in a listed drug, or to affect 
the status, if any, of such information as trade secret or 
confidential commercial information for purposes of section 
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301(j) of this Act, section 552 of title 5, United States Code, 
or section 1905 of title 18, United States Code.’’. 
(b) GUIDANCE.— 
(1) IN GENERAL.—Not later than one year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall issue draft guid-
ance, or update guidance, describing how the Sec-
retary will determine whether a drug is qualitatively 
and quantitatively the same as the listed drug (as 
such terms are used in section 505(j)(3)(H) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a)), including with respect to assessing 
pH adjusters. 
(2) PROCESS.—In issuing guidance under this 
subsection, the Secretary of Health and Human Serv-
ices shall— 
(A) publish draft guidance; 
(B) provide a period of at least 60 days for 
comment on the draft guidance; and 
(C) after considering any comments received 
and not later than one year after the close of the 
comment period on the draft guidance, publish 
final guidance. 
(c) APPLICABILITY.—Section 505(j)(3)(H) of the Fed-
eral Food, Drug, and Cosmetic Act, as added by subsection 
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(a), applies beginning on the date of enactment of this Act, 
irrespective of the date on which the guidance required by 
subsection (b) is finalized. 
SEC. 11. MEDICARE IMPROVEMENT FUND. 
Section 1898(b)(1) of the Social Security Act (42 
U.S.C. 1395iii(b)(1)) is amended— 
(1) by striking ‘‘fiscal year 2026’’ and inserting 
‘‘fiscal year 2027’’; and 
(2) by striking ‘‘$1,804,000,000’’ and inserting 
‘‘$3,047,000,000’’. 
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Union Calendar No. 304 
119TH CONGRESS 
1ST SESSION 
H. R. 1262 
[Report No. 119–352] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act with respect to molecularly targeted pediatric 
cancer investigations, and for other purposes. 
OCTOBER 31, 2025 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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