[Congressional Record Volume 170, Number 148 (Monday, September 23, 2024)]
[House]
[Pages H5582-H5587]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     GIVE KIDS A CHANCE ACT OF 2024

  Mr. BUCSHON. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 3433) to amend the Federal Food, Drug, and Cosmetic Act with 
respect to molecularly targeted pediatric cancer investigations, and 
for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 3433

       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 2024''.
       (b) Table of Contents.--The table of contents for this Act 
     is as follows:

Sec. 1. Short title; table of contents.

                      TITLE I--GIVE KIDS A CHANCE

Sec. 101. Research into pediatric uses of drugs; additional authorities 
              of Food and Drug Administration regarding molecularly 
              targeted cancer drugs.
Sec. 102. Ensuring completion of pediatric study requirements.
Sec. 103. FDA report on PREA enforcement.
Sec. 104. Extension of authority to issue priority review vouchers to 
              encourage treatments for rare pediatric diseases.
Sec. 105. Limitations on exclusive approval or licensure of orphan 
              drugs.
Sec. 106. Program for pediatric studies of drugs.

    TITLE II--UNITED STATES-ABRAHAM ACCORDS COOPERATION AND SECURITY

Sec. 201. Establishment of Abraham Accords Office within Food and Drug 
              Administration.

        TITLE III--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

Sec. 301. Registration fees.

                      TITLE I--GIVE KIDS A CHANCE

     SEC. 101. 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:

[[Page H5583]]

       ``(A) In general.--For purposes of paragraph (1)(B), the 
     investigation described in this paragraph is (as determined 
     by the Secretary) 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 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 to be 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 has been previously 
     approved to treat an adult cancer.

       ``(iii) Results of already-completed preclinical studies of 
     application drug.--The Secretary may require that reports on 
     an investigation required pursuant to paragraph (1)(B) 
     include the results of all preclinical studies on which the 
     decision to conduct such investigation was based.
       ``(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) shall apply 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 
     2 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 3 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.
       (B) Findings.--Not later than 7 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. 102. 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. 103. 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; 
     and''.

     SEC. 104. 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 ``September 30, 2024, unless'' and all 
     that follows through the period at the end and inserting 
     ``September 30, 2029.''.
       (b) 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--

[[Page H5584]]

       (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. 105. 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. 106. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

       Section 409I(d) of the Public Health Service Act (42 U.S.C. 
     284m(d)) is amended to read as follows:
       ``(d) Funding.--Of the amount made available for pediatric 
     research to each national research institute and national 
     center under this title for each of fiscal years 2025, 2026, 
     and 2027, the Director of NIH is authorized to make available 
     up to one percent of such amount for pediatric research under 
     this section.''.

    TITLE II--UNITED STATES-ABRAHAM ACCORDS COOPERATION AND SECURITY

     SEC. 201. 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;
       ``(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
       ``(C) facilitate feedback between the Food and Drug 
     Administration and such parties located within Abraham 
     Accords countries prior to submission of an application under 
     section 505(b), 505(j), or 515 of this Act or section 351(a) 
     or 351(k) of the Public Health Service Act, or a notification 
     under section 510(k) of this Act, such as feedback on 
     research, development, and manufacturing of drugs, biologics, 
     and medical devices; 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.''.
       (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 subparagraphs 
     (B) and (C) of section 1015(c)(1) 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)).

        TITLE III--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

     SEC. 301. REGISTRATION FEES.

       Section 372 of the Public Health Service Act (42 U.S.C. 
     274) is amended 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 only be collected 
     and distributed 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

[[Page H5585]]

     the awardees described in subsection (b)(1)(A).
       ``(4) Transparency.--The Secretary shall--
       ``(A) promptly post on the Internet website of the Organ 
     Procurement and Transplant 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.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Indiana (Mr. Bucshon) and the gentleman from New Jersey (Mr. Pallone) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Indiana.


                             General Leave

  Mr. BUCSHON. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Indiana?
  There was no objection.
  Mr. BUCSHON. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 3433, the Give Kids a Chance 
Act of 2024, and thank Representatives McCaul, Eshoo, and Bilirakis for 
their hard work on this important piece of legislation.
  Mr. Speaker, I am excited that we have reached broad bipartisan 
agreement on this comprehensive bill, which will provide hope to 
approximately 30 million Americans affected by rare diseases.
  Currently, only about 500 of these diseases have FDA-approved 
treatments. This legislation will foster the development of more 
pediatric rare disease treatments by strengthening the orphan drug 
pathway, ensuring drugs are studied for children battling cancer, and 
reauthorizing the rare pediatric disease priority review voucher 
program, which is set to expire on September 30.
  The PRV program has been a lifeline for patients who require 
specialized treatments that would not be developed without the 
incentive this program provides.
  I am also supportive of the other provisions in this bill, which 
would increase organ transplant rates by strengthening OPTN operations 
and require the FDA to establish an office in a country that has signed 
the Abraham Accords.
  I am grateful to Representatives Harshbarger and Vargas for their 
leadership on this effort to facilitate operations between the FDA and 
regulatory authorities and innovators in Abraham Accords countries.
  There has been a lot of discussion about moving supply chains for 
medical products back to the U.S. and our allies, and this office is a 
good step to help do just that.
  Mr. Speaker, I encourage my colleagues to support this bill, and I 
reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of H.R. 3433, the Give Kids a 
Chance Act, sponsored by Representatives McCaul and Eshoo.
  This bill includes several strong bipartisan pieces of legislation, 
and I am pleased that our Republican colleagues agreed to work with us 
on advancing important policies.
  This legislation will help expand access to care for patients with 
rare diseases and complex medical needs, increase research and 
development into rare pediatric diseases, and improve regulatory 
certainty.
  This bill will help in our efforts to bring new treatments to 
pediatric patients with more advanced forms of cancer. It also includes 
important sections of H.R. 6664, Representative Eshoo's bill, the 
Innovation in Pediatric Drugs Act. Specifically, it gives the Food and 
Drug Administration new enforcement authority to take action against 
companies that do not conduct required studies in pediatric patients.
  The bill also includes critical language introduced by Representative 
Matsui as part of H.R. 7383, the Retaining Access and Restoring 
Exclusivity Act, or RARE Act, and this will clarify FDA's long-held 
treatment of orphan drug exclusivity and bring new treatments to more 
patients suffering from rare diseases. These provisions all advance our 
goals of accelerating the development of novel, safe, and effective 
treatments and improving outcomes for patients.
  These bills are going to make a difference, but I remain disappointed 
that my Republican colleagues have been unwilling to consider necessary 
changes to require drug manufacturers to study their approved rare 
disease drugs in pediatric populations.

                              {time}  1545

  It is disappointing that my Republican colleagues refuse to hold drug 
manufacturers' feet to the fire and have decided to move forward with a 
long-term reauthorization of the priority review voucher program, or 
PRV, without requiring manufacturers to study rare disease drugs in 
pediatric patients.
  I have been consistent in my belief that we need reforms to the PRV 
program. Unfortunately, we still have not seen the compelling evidence 
that this program is functioning how Congress intended it to. That is 
why I am pleased that the bill includes a requirement for the 
Government Accountability Office to conduct a new study and report on 
the effectiveness of the program in attaining our original intent. 
Previous reports from GAO on the program, and continued research from 
academics, show that there is little evidence that it incentivized the 
products Congress intended to help come to market.
  I continue to believe that additional guardrails are needed to better 
target the intent of the program, but despite these concerns, I am 
pleased that this bill includes important provisions to ensure that our 
medical product supply chain can be strengthened by working with 
international partners that believe in both tolerance and respect for 
every person as well as advancement of science and medicine. I look 
forward to working with our Republican colleagues to ensure FDA 
receives the funding necessary to implement this policy and establish 
an FDA office in Israel.
  I am also pleased that this legislation provides the Health Resources 
and Services Administration the authority to modernize the organ 
transplant system. This system is lifesaving for many Americans, and I 
am glad that we can continue to support these much-needed reform 
efforts.
  I believe that we could have achieved more for patients in this 
legislation. However, since there are strong bipartisan policies 
included here, I encourage all of my colleagues to vote ``yes'' on this 
important bill, and I reserve the balance of my time.
  Mr. BUCSHON. Mr. Speaker, I yield 5 minutes to the gentleman from 
Texas (Mr. McCaul).
  Mr. McCAUL. Mr. Speaker, I thank the gentleman from Indiana for 
yielding.
  Mr. Speaker, as a founder of the Childhood Cancer Caucus 15 years 
ago, I have met countless cancer patients and advocates who have asked 
me for one thing: to give the kids a chance. They want a chance to 
receive better and safer treatments that preserve their quality of 
life, a chance to beat childhood cancer, and a chance to eradicate this 
disease once and for all.
  The Give Kids a Chance Act does just that.
  The bill is simple. It directs drug companies researching combination 
drug therapies for adults to also research them for children, where 
appropriate. This will allow us to treat children the same as we treat 
adults.
  With 235 cosponsors, this legislation is one of the most bipartisan 
bills in Congress because there is nothing partisan or political about 
a child with cancer.
  Mr. Speaker, I thank Mr. Bilirakis from Florida and Ms. Anna Eshoo 
from California, my partner in this. I also

[[Page H5586]]

thank Chair Cathy McMorris Rodgers and Ranking Member Frank Pallone for 
all of their help in making this come together.
  Included in this legislation is another one of my bills, the Creating 
Hope Reauthorization Act. We first passed this legislation in 2012 to 
create the pediatric priority review voucher program within the FDA 
because we found that there was no market incentive for pharmaceutical 
companies to develop cancer treatments for children. This program 
provides the incentives.
  Since its inception in 2012, 53 vouchers have been awarded for 
treatments of 39 different rare pediatric diseases, 36 of which 
previously had no FDA-approved treatments. These diseases typically led 
to death before a child can reach adulthood, but not anymore.
  A dear friend of mine, Dr. Allison from MD Anderson in my home State 
of Texas, was able to use the voucher program to obtain FDA approval 
for a treatment called CAR-T immunotherapy. Immunotherapy is a 
breakthrough cancer treatment not just for children but for all adults. 
He received the Nobel Prize in medicine for it.
  This bill would reauthorize that successful program for another 5 
years.
  We just had our 15-year summit, and these children, I have to say to 
the ranking member and to the chair, who I hope is listening, how much 
joy this gave to their lives. These children who have either survived 
cancer or are going through cancer, some can make it, some may not, but 
this gives them hope.
  I founded the caucus to give them a voice in the Congress because 
they didn't have one. They didn't have high-powered lobbyists, but they 
have us. This is the result of their voices.
  We wouldn't be standing here today considering this legislation 
without the help of patient advocates, including my dear childhood 
cancer friends, Sadie Keller, Sophie Ryan, Brianna Commerford, and 
Ailani Myers, and so many other brave children who have joined me in 
advocating tirelessly on this important issue.
  By the way, Mr. Speaker, these kids are tougher than any adults I 
know, and they are my biggest inspiration in life.
  Mr. Speaker, I am proud that my colleagues have come together in a 
bipartisan spirit to do what is right for our children, which will 
influence them for decades to come.
  Mr. PALLONE. Mr. Speaker, I have no additional speakers, and I 
reserve the balance of my time.
  Mr. BUCSHON. Mr. Speaker, I yield 3 minutes to the gentleman from 
Florida (Mr. Bilirakis).
  Mr. BILIRAKIS. Mr. Speaker, I thank Dr. Bucshon, a great friend of 
mine who does an outstanding job on our committee, for yielding.
  Mr. Speaker, I rise in strong support of H.R. 3433, the Give Kids a 
Chance Act, by Representative McCaul. His legislation strengthens 
pathways for treatments and cures for children across the Nation.
  The Give Kids a Chance Act would require that new studies of 
pediatric cancer trials focus on combination therapies rather than 
solely single-use drugs. This bill requires these pathways for children 
with cancer in cases where both the drugs are FDA approved and owned by 
the same company.

  These combination products may help unlock new treatment options for 
pediatric cancers and help extend the lives of children battling a rare 
cancer.
  I am proud to cosponsor this legislation. Furthermore, I am 
particularly glad to see that this comprehensive package contains 
provisions of two bills I co-lead, the Creating Hope Reauthorization 
Act and the RARE Act. These bills will support innovation for pediatric 
rare disease treatments and cures.
  The Creating Hope Reauthorization Act will extend the FDA's rare 
pediatric priority review voucher program for another 5 years, through 
fiscal year 2029. This voucher serves as a critical and necessary 
incentive for innovators to invest in research and development of 
pediatric rare diseases.
  Due to their extremely small patient populations, these diseases too 
often go unnoticed, unfortunately. However, the voucher program allows 
innovative rare disease companies to receive FDA priority review if 
they get an approval for a pediatric rare disease. These vouchers can 
then be used to expedite consideration of new treatments in the 
pipeline, or transferred or sold to another company to recoup 
investment losses.
  This successful FDA incentive does not cost any taxpayer dollars and 
must be extended to continue the pipeline of treatments for children 
with rare diseases.
  I was proud to lead the effort in the Energy and Commerce Committee 
with my good friend and colleague, Anna Eshoo. We are going to miss 
her. She is retiring, but hopefully, she will be around to give us some 
advice in the future.
  Again, we have bipartisan agreement on this. It is so very important 
for our children.
  Mr. Speaker, I ask my colleagues to join me in supporting H.R. 3433 
off the floor today.
  Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.
  Mr. BUCSHON. Mr. Speaker, I yield 5 minutes to the gentlewoman from 
Tennessee (Mrs. Harshbarger).
  Mrs. HARSHBARGER. Mr. Speaker, I rise today in strong support of H.R. 
3433, the Give Kids a Chance Act, which is bipartisan legislation to 
help speed up the process for getting treatments to children with 
cancer and other rare diseases.
  I am pleased that this bill also includes a modified version of 
bipartisan legislation I have been leading with Democratic 
Representative Juan Vargas: the United States-Abraham Accords 
Cooperation and Security Act.
  This section of H.R. 3433 will establish a U.S. Food and Drug 
Administration office in the Abraham Accords region, creating a staging 
ground for technical assistance and friend-shoring collaboration 
between the U.S. and Abraham Accords countries, for development of and 
bringing to our markets lifesaving drugs.
  I thank House Committee on Energy and Commerce Chair Rodgers and 
Ranking Member Pallone for working with me to advance this important 
initiative. Chair Rodgers has been a strong ally in developing this.
  Our continued dependence on adversarial countries like China for 
pharmaceutical products endangers our medical supply chains and 
jeopardizes our national security. More than 80 percent of the active 
pharmaceutical ingredients for drugs sold in the U.S. are imported from 
foreign countries, primarily China and India.
  As our country works toward securing critical healthcare supply 
chains from reliance on adversarial countries like China, the strategy 
of friend-shoring or near-shoring has emerged as part of the solution 
for industries where domestic production is not yet fully available.
  Leveraging the Abraham Accords countries' robust biopharmaceutical 
industries to help diversify and protect our access to crucial medical 
supply chains that don't rely on China is a commonsense step to work 
with our natural allies in our quest to safeguard our access to vital 
medical products.
  We need to begin this process of fortifying our medical supply chains 
as soon as possible because we have a big hill to climb. With adoption 
of H.R. 3433 and establishment of an FDA technical assistance office in 
the Abraham Accords region, we begin climbing that hill.
  Mr. Speaker, I urge all of my colleagues to support this bipartisan 
legislation.
  Mr. PALLONE. Mr. Speaker, obviously, this bill does a lot to help 
childhood disorders. It is a very important bill, and I urge that it be 
passed on a bipartisan basis.
  Mr. Speaker, I yield back the balance of my time.
  Mr. BUCSHON. Mr. Speaker, in closing, I encourage a ``yes'' vote on 
this bill, and I yield back the balance of my time.
  Ms. ESHOO. Mr. Speaker, today, the House will vote on my legislation, 
H.R. 3433, the Give Kids a Chance Act.
  My thanks to Reps. Michael McCaul (R-TX) and Gus Bilirakis (R-FL), 
the chairwoman of the Energy and Commerce Committee Cathy McMorris 
Rodgers (R-WA) and Ranking Member Frank Pallone (D-NJ) for their very 
hard work on this important effort.
  H.R. 3433 is the most comprehensive legislation to improve and 
address childhood cancer and rare disease in over a decade.
  As medicines become more sophisticated and we improve our 
understanding of the

[[Page H5587]]

deadliest diseases facing children in our country, our laws must keep 
up.
  This legislation will ensure children have access to the most 
innovative treatments and therapies for cancer and rare disease, and it 
does that by doing the following.
  It reauthorizes the FDA's pediatric priority voucher program for five 
years. The program expires September 23, 2024 and we cannot let 
critical tools to encourage the development of drugs for children to 
lapse.
  It directs companies to conduct pediatric trials with combinations of 
drugs. More than 40 combination therapies are approved for adults, but 
only 2 are approved for children. This legislation fixes that inequity. 
Every member of the Energy and Commerce Committee and 392 Members of 
the House voted for this provision as part of the user fees package 
last Congress.
  It brings the FDA's enforcement capabilities for children on par with 
that of adults, giving the FDA new options to ensure pediatric studies 
are completed on time. Today, the FDA can only remove a drug from the 
market if pediatric studies are not completed. This bill gives the FDA 
more flexibility to ensure companies follow the law.
  The bill dedicates existing funds for pediatric research through the 
NIH's Best Pharmaceuticals for Children Act Program over the next three 
years, the program's first funding update since it was authorized in 
2002. Zero new funding will be used.
  This bill was advanced by the House Energy and Commerce Committee 
unanimously last week.
  Children are not little adults. They deserve effective medicines, 
just as adults do. The Give Kids a Chance Act will get children what 
they deserve and save lives.
  I urge my colleagues to vote for this critical legislation.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Indiana (Mr. Bucshon) that the House suspend the rules 
and pass the bill, H.R. 3433, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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