[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3433 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 3433

   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

                              May 17, 2023

Mr. McCaul (for himself, Ms. Eshoo, Mr. Kelly of Pennsylvania, Mrs. Kim 
  of California, Mr. Smith of New Jersey, Ms. Schrier, Mr. Bacon, Mr. 
Moylan, Mr. Buchanan, Mr. Fitzpatrick, Mr. Huizenga, Mr. Grothman, Mr. 
Johnson of Ohio, and Mr. Phillips) introduced the following bill; which 
          was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 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.

    This Act may be cited as the ``Give Kids a Chance Act of 2023''.

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 (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 shall--
            (1) not later than 12 months after the date of enactment of 
        this Act, issue draft guidance on the implementation of the 
        requirements in 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), 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).
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