119-hr1262

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1262 Reported in House

    (RH) ]

<DOC>

 Union Calendar No. 304
119th CONGRESS
 1st Session
 H. R. 1262

 [Report No. 119-352]

 To amend the Federal Food, Drug, and Cosmetic Act with respect to 
 molecularly targeted pediatric cancer investigations, and for other 
 purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 February 12, 2025

Mr. McCaul (for himself, Mr. Bilirakis, Mrs. Dingell, Ms. Schrier, Mrs. 
Harshbarger, Ms. Matsui, Mr. Crenshaw, Ms. Castor of Florida, Mr. Kelly 
 of Pennsylvania, Mrs. Trahan, and Mr. Weber of Texas) introduced the 
 following bill; which was referred to the Committee on Energy and 
 Commerce

 October 31, 2025

 Additional sponsors: Mr. Wittman, Mr. Allen, Mr. Zinke, Mr. Evans of 
 Colorado, Mr. Higgins of Louisiana, Mr. Gimenez, Mrs. Miller of West 
Virginia, Mr. Cline, Mr. Sessions, Mr. Rulli, Mr. Mullin, Mr. Soto, Mr. 
 Keating, Mrs. McIver, Mr. Case, Mr. Castro of Texas, Ms. Sewell, Ms. 
 Wasserman Schultz, Ms. Norton, Mr. McGarvey, Mr. Diaz-Balart, Mr. 
 Wilson of South Carolina, Mr. LaHood, Mr. Van Drew, Ms. Malliotakis, 
 Mr. Larson of Connecticut, Mr. Bishop, Ms. DelBene, Mr. Harder of 
California, Mr. Grijalva, Mr. Schneider, Ms. Scanlon, Mr. Finstad, Mr. 
Huizenga, Mrs. Miller of Illinois, Mr. Yakym, Mr. Costa, Ms. McCollum, 
Mrs. Hayes, Mr. Garcia of California, Mr. Davis of North Carolina, Mr. 
Graves, Mr. LaMalfa, Mr. Carey, Mrs. Kim, Mr. Lawler, Mr. Grothman, Ms. 
 Titus, Ms. Salinas, Ms. Brownley, Mr. Ciscomani, Ms. Bonamici, Mr. 
 Fitzpatrick, Mr. Vicente Gonzalez of Texas, Mr. Owens, Mrs. Cherfilus-
McCormick, Mr. Joyce of Pennsylvania, Mr. Nehls, Mr. Bacon, Ms. Letlow, 
 Mr. Balderson, Mr. Takano, Ms. Jayapal, Mr. Cohen, Mr. Panetta, Mr. 
 Nadler, Mr. McGuire, Mr. Mann, Mrs. Kiggans of Virginia, Ms. Leger 
 Fernandez, Mr. Quigley, Mr. Cleaver, Ms. Tenney, Mr. Krishnamoorthi, 
 Mr. Kiley of California, Mr. Auchincloss, Mr. Turner of Ohio, Mr. 
 Moulton, Mr. Austin Scott of Georgia, Mr. Pocan, Mrs. Houchin, Ms. 
 McBride, Mr. Landsman, Mr. Alford, Mr. Calvert, Mr. Latimer, Mr. 
 Moylan, Ms. Ross, Mr. Cole, Ms. Davids of Kansas, Mr. Smith of 
 Nebraska, Ms. Omar, Mr. Steube, Mr. Suozzi, Ms. McClellan, Mr. 
 Carbajal, Mr. Norcross, Mr. Peters, Mr. Magaziner, Mr. Valadao, Mr. 
Scott Franklin of Florida, Mr. Meuser, Mr. Miller of Ohio, Mr. Rouzer, 
 Mr. Thompson of Pennsylvania, Mr. Shreve, Mr. Edwards, Mr. Moolenaar, 
 Ms. Gillen, Ms. Stansbury, Mr. Williams of Texas, Mr. Fallon, Mr. 
 Westerman, Mr. Newhouse, Mr. Hamadeh of Arizona, Mr. Baumgartner, Mr. 
Cuellar, Ms. Houlahan, Ms. Stefanik, Mr. Smith of New Jersey, Ms. Meng, 
 Mr. Crow, Mr. Lieu, Mr. Vindman, Ms. Bynum, Mr. Kennedy of New York, 
 Mr. Taylor, Mr. Smucker, Mr. Fleischmann, Ms. Craig, Mr. Mrvan, Mr. 
Evans of Pennsylvania, Ms. Salazar, Mr. Van Orden, Ms. Brown, Mr. Ruiz, 
 Mrs. Hinson, Mr. Garamendi, Mr. Morelle, Mr. Jackson of Illinois, Mr. 
 Mills, Mr. Moore of North Carolina, Mrs. Luna, Mr. Tran, Mr. Thompson 
 of Mississippi, Mrs. Foushee, Mr. Boyle of Pennsylvania, Mr. Deluzio, 
Mr. Wied, Mr. Torres of New York, Mr. Veasey, Ms. Lee of Pennsylvania, 
 Mr. Gottheimer, Mr. Nunn of Iowa, Mr. Figures, Mr. Subramanyam, Ms. 
 Clarke of New York, Mr. Green of Texas, Mr. Riley of New York, Mr. 
 Lynch, Mrs. Bice, Mr. Vargas, Ms. Wilson of Florida, Mr. Fields, Mr. 
Frost, Mr. Swalwell, Mr. Tonko, Ms. Scholten, Mr. Jackson of Texas, Ms. 
 Kaptur, Ms. Ansari, Mrs. Radewagen, Mr. Schmidt, Mrs. Fletcher, Mr. 
Steil, Mr. Moran, Mr. McGovern, Mr. Correa, Mr. Webster of Florida, Mr. 
 Bresnahan, Mr. Garbarino, Mr. Burchett, Ms. Budzinski, Ms. Sherrill, 
Ms. Johnson of Texas, Mr. Conaway, Ms. Tokuda, Mr. Bentz, Mr. Vasquez, 
Mr. Flood, Mr. Pfluger, Ms. Pettersen, Mr. Stanton, Mr. Loudermilk, Ms. 
 Dean of Pennsylvania, Mr. Walberg, Mr. Messmer, Mr. Carter of 
 Louisiana, Ms. Strickland, Mrs. Sykes, Ms. Jacobs, Mr. Casten, Ms. 
 Adams, Mr. Sorensen, Mr. Espaillat, Mrs. McClain Delaney, Ms. Waters, 
 Ms. Kelly of Illinois, Mr. Bera, Ms. Schakowsky, Mr. Foster, Mr. 
 Moskowitz, Mr. Langworthy, Mr. LaLota, Mr. Aderholt, Mr. Rutherford, 
 Mr. Kennedy of Utah, Mr. Bost, Mr. Amodei of Nevada, Mr. Johnson of 
 Georgia, Ms. Pou, Mr. Garcia of Illinois, Ms. Velazquez, Ms. Elfreth, 
 Ms. Goodlander, Mr. Khanna, Ms. King-Hinds, Mr. Buchanan, Ms. Lee of 
 Florida, Mr. Goldman of Texas, Ms. Crockett, Ms. Stevens, Mr. Carson, 
 Mr. Levin, Mr. Raskin, Mr. Thompson of California, Mr. Obernolte, Mr. 
 Reschenthaler, Ms. Lofgren, Mr. Davis of Illinois, Mr. Mannion, Mrs. 
 Miller-Meeks, Mr. Kustoff, Mr. Cloud, Mr. Menendez, Mr. Neguse, Mr. 
Goldman of New York, Mr. Ezell, Mr. Harrigan, Mr. Crank, Mr. Cisneros, 
Mr. Haridopolos, Mr. Min, Mr. Hernandez, Mr. Timmons, Mrs. McBath, Mr. 
 Kean, Mr. Pappas, Mr. Himes, Ms. Escobar, Mr. Olszewski, Mr. Smith of 
 Washington, Ms. Sanchez, Ms. Randall, Ms. Pingree, Ms. Tlaib, Ms. 
Rivas, Ms. McDonald Rivet, Ms. Friedman, Mr. Gooden, Mr. Feenstra, Ms. 
 Kamlager-Dove, Ms. Perez, Mr. Huffman, Mr. Amo, Mr. DeSaulnier, Ms. 
 DeGette, Mr. Hurd of Colorado, Mr. Moore of Utah, Mr. McCormick, Mr. 
 Womack, Mr. Bergman, Mr. Bell, Ms. Chu, Ms. Lee of Nevada, Mr. 
Whitesides, Mr. David Scott of Georgia, Mr. Walkinshaw, Mr. Arrington, 
Mr. Thanedar, Ms. Hoyle of Oregon, Mrs. Watson Coleman, Ms. Balint, Mr. 
Gray, Mr. Crawford, Mr. Mackenzie, Mr. Simpson, Mr. Carter of Georgia, 
 Mr. Baird, Mr. Mfume, Mr. Davidson, Mr. Bean of Florida, and Mr. 
 Sherman

 October 31, 2025

 Reported with an amendment, committed to the Committee of the Whole 
 House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
 in italic]
 [For text of introduced bill, see copy of bill as introduced on 
 February 12, 2025]

_______________________________________________________________________

 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act with respect to 
 molecularly targeted pediatric cancer investigations, 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; 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 
 Administration.

Sec. 10. Increasing transparency in generic drug applications.

Sec. 11. Medicare Improvement Fund.

SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES 
 OF FOOD AND DRUG ADMINISTRATION REGARDING MOLECULARLY 
 TARGETED CANCER DRUGS.

    (a) In General.--

    (1) Additional active ingredient for application drug; 
 limitation regarding novel-combination application drug.--
 

Section 505B

    (a)

    (3) of the Federal Food, Drug, and Cosmetic Act 
 (21 U.S.C. 355c

    (a)

    (3) ) is amended--
        (A) by redesignating subparagraphs
        (B) and
            (C) as 
 subparagraphs
            (C) and
            (D) , respectively; and
        (B) by striking subparagraph
        (A) and inserting the 
 following:
 ``
        (A) In general.--For purposes of paragraph

    (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 Service Act is in 
 effect; and
 ``

    (bb) that is determined 
 by the Secretary, after 
 consultation with the 
 applicant, to be part of 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 
 submitting the application 
 under paragraph

    (1)
        (B) ; and
 ``

    (bb) that is directed at 
 a molecular target that the 
 Secretary determines to be 
 substantially relevant to the 
 growth or progression of a 
 pediatric cancer.
 ``
        (B) Additional requirements.--
 ``
            (i) Design of investigation.--A 
 molecularly targeted pediatric cancer 
 investigation referred to in subparagraph
        (A) shall be designed to yield clinically 
 meaningful pediatric study data that is 
 gathered using appropriate formulations for 
 each age group for which the study is required, 
 regarding dosing, safety, and preliminary 
 efficacy to inform potential pediatric 
 labeling.
 ``
            (ii) Limitation.--An investigation 
 described in subparagraph
        (A)
            (ii) may be 
 required only if the drug or biological product 
 for which the application referred to in 
 paragraph

    (1)
        (B) contains either--
 ``
            (I) a single new active 
 ingredient; or
 ``
            (II) more than one active 
 ingredient, if an application for the 
 combination of active ingredients has 
 not previously been approved but each 
 active ingredient is in a drug product 
 that has been previously approved to 
 treat an adult cancer.
 ``
            (iii) Results of already-completed 
 preclinical studies of application drug.--With 
 respect to an investigation required pursuant 
 to paragraph

    (1)
        (B) , the Secretary may require 
 the results of any completed preclinical 
 studies relevant to the initial pediatric study 
 plan be submitted to the Secretary at the same 
 time that the initial pediatric study plan 
 required under subsection

    (e)

    (1) is submitted.
 ``
            (iv) Rule of construction regarding 
 inactive ingredients.--With respect to a 
 combination of active ingredients referred to 
 in subparagraph
        (A)
            (ii) , such subparagraph 
 shall not be construed as addressing the use of 
 inactive ingredients with such combination.''.

    (2) Determination of applicable requirements.--

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 application that is 
 subject to the requirements of subparagraph
        (B) shall 
 be subject to the requirements 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 subparagraph
        (A) ''; and
        (B) in paragraph

    (3)
            (D) , as redesignated by 
 paragraph

    (1)
        (A) of this subsection, by striking ``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 enactment of 
 this Act, issue draft guidance on the implementation 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 services.--Not later than 
 6 years after the date of enactment 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 efforts, in coordination 
 with industry, to ensure implementation 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 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 consideration of any benefits 
 to, or burdens on, pediatric 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 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 conducted 
 under subparagraph
        (A) .

SEC. 3. ENSURING COMPLETION OF PEDIATRIC STUDY REQUIREMENTS.

    (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.--Beginning 270'';

    (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 
 biological 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 satisfying 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 biological 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 preceding paragraph

    (1) , the 
 Secretary shall--
 ``
        (A) issue a noncompliance letter pursuant to 
 paragraph

    (1) ;
 ``
        (B) provide such person with a 45-day period 
 beginning on the date of receipt of such noncompliance 
 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 requirement.''.
            (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 inserting ``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 amended--

    (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 payments 
 under 

section 303 of the Federal Food, Drug, and Cosmetic Act 
 (21 U.S.C. 353) for failure to comply with requirements under 
 such 

section 505B, including, 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 REVIEW VOUCHERS TO 
 ENCOURAGE TREATMENTS 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, unless'' and all that follows through the 
period at the end and inserting ``September 30, 2029.''.

    (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 application under 

section 505

    (b)

    (1) or 

section 351

    (a) of the Public Health 
 Service Act for which the priority 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 Pediatric Disease Priority 
Voucher Awards in Incentivizing Rare Pediatric Disease Drug 
Development.--

    (1) GAO study.--
        (A) Study.--The Comptroller General of the United 
 States shall conduct a study of the effectiveness of 
 awarding rare pediatric disease priority vouchers under 
 

section 529 of the Federal Food, Drug, and Cosmetic Act 
 (21 U.S.C. 360ff), as amended by subsection

    (a) , in the 
 development of human drug products that treat or 
 prevent rare pediatric diseases (as defined in such 
 

section 529).
        (B) Contents of study.--In conducting the study 
 under subparagraph
        (A) , the Comptroller General shall 
 examine the following:
            (i) The indications for each drug or 
 biological product that--
            (I) is the subject of a rare 
 pediatric 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 
 review voucher was awarded; and
            (II) was approved under 

section 505 
 of the Federal Food, Drug, and Cosmetic 
 Act (42 U.S.C. 355) or licensed 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 prevention 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 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 
 prevention 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.
            (ix) Whether, and to what extent, companies 
 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, pediatric 
 review vouchers awarded under such section were 
 successful in stimulating development and 
 expedited patient access to drug products for 
 treatment or prevention of a rare pediatric 
 disease that wouldn't otherwise take place 
 without the incentive provided 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 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 conducted under paragraph

    (1) .

SEC. 6. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICENSURE 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 condition'' 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 ``, relating 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 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 Service 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 inserting ``section, $25,000,000 for 
each of fiscal years 2026 through 2028.''.

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 subparagraphs
            (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 semicolon;
            (C) in subparagraph
            (C) , by striking ``twenty-four-
 hour telephone service'' and inserting ``24-hour 
 telephone or information technology service'';
            (D) in each of subparagraphs
        (B) through
            (M) , by 
 striking the comma at the end and inserting a 
 semicolon;
        (E) in subparagraph
        (N) , by striking 
 ``transportation, and'' and inserting 
 ``transportation;'';
        (F) in subparagraph
        (O) , by striking the period and 
 inserting a semicolon; and
        (G) by adding at the end the following:
 ``
        (P) encourage the integration of electronic 
 health records systems through application programming 
 interfaces (or successor technologies) among hospitals, 
 organ procurement organizations, and transplant 
 centers, including the use of automated electronic 
 hospital referrals and the grant of remote, electronic 
 access to hospital electronic health records of 
 potential donors by organ procurement organizations, in 
 a manner that complies with the privacy regulations 
 promulgated under the Health Insurance Portability and 
 Accountability Act of 1996, at part 160 of title 45, 
 Code of Federal Regulations, and subparts 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 Procurement and Transplantation 
 Network system and failed to be transplanted, and other 
 appropriate statistics, which should be updated more 
 frequently than annually.''; and

    (2) by adding at the end the following:
 ``
            (d) Registration Fees.--
 ``

    (1) In general.--The Secretary may collect registration 
 fees from any member of the Organ Procurement 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 
 Transplantation Network. Such registration fees are authorized 
 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 Department of 
 Health and Human Services as discretionary offsetting 
 collections; and
 ``
        (B) be available, only to the extent and in the 
 amounts provided in advance in appropriations Acts, to 
 distribute such fees among awardees described in 
 subsection

    (b)

    (1)
        (A) .
 ``

    (4) Transparency.--The Secretary shall--
 ``
        (A) promptly post on the website of the Organ 
 Procurement and Transplantation Network--
 ``
            (i) the amount of registration fees 
 collected under this subsection from each 
 member of the Organ Procurement and 
 Transplantation Network; and
 ``
            (ii) a list of activities such fees are 
 used to support; and
 ``
        (B) update the information posted pursuant 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 Comptroller General of the 
 United States shall, to the extent data are available--
 ``
        (A) conduct a review concerning the activities 
 under this subsection; and
 ``
        (B) submit to the Committee on Health, Education, 
 Labor, and Pensions and the Committee on Finance of the 
 Senate and the Committee on Energy and Commerce of the 
 House of Representatives, a report on such review, 
 including related recommendations, as applicable.
 ``

    (6) Sunset.--The authority to collect registration 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 Accords 
 Office in an Abraham Accords country; and
 ``
        (B) establish such office; and
 ``

    (2) assign to such office such personnel of the Food and 
 Drug Administration as the Secretary determines necessary to 
 carry out the functions of such office.
 ``
            (c) Duties.--The Secretary, acting through the Director of the 
Abraham Accords Office, shall--
 ``

    (1) after the Abraham Accords Office is established--
 ``
        (A) as part of the Food and Drug Administration's 
 work to strengthen the international oversight of 
 regulated commodities, provide technical assistance to 
 regulatory partners in Abraham Accords countries on 
 strengthening regulatory oversight and converging 
 regulatory requirements for the oversight of regulated 
 products, including good manufacturing practices and 
 other issues relevant to manufacturing medical 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, development, and manufacturing of products 
 regulated 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 country 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 Federal 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 Congress a report on the Abraham 
 Accords Office, including--
        (A) an evaluation of how the Office has advanced 
 progress toward conformance with Food and Drug 
 Administration regulatory requirements by manufacturers 
 in the Abraham Accords countries;
        (B) a numerical count of parties that the Office 
 has helped facilitate interactions or feedback 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 provided 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 intends to submit an 
abbreviated application under this subsection for a drug that is 
required by regulation to contain 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 
justification 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 
information 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 quantitatively 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.
 ``
            (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 determination 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 reasons of safety or 
 effectiveness; or
 ``
            (II) the Secretary makes a written determination that the 
 prior determination must be changed because an error has been 
 identified.
 ``
            (iv) If the Secretary makes a written determination described in 
clause
            (iii) 
            (II) , the Secretary shall provide notice 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 purposes 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 information 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 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 guidance, or update guidance, 
 describing how the Secretary 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 Services 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 Federal Food, Drug, 
and Cosmetic Act, as added by subsection

    (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''.
 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 Committee of the Whole 
 House on the State of the Union, and ordered to be printed