[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3239 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 3239

   To amend the Federal Food, Drug, and Cosmetic Act to establish a 
  program to provide additional incentives for the development of new 
       drugs to treat pediatric cancers, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 14, 2016

 Mr. Bennet (for himself and Mr. Rubio) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to establish a 
  program to provide additional incentives for the development of new 
       drugs to treat pediatric cancers, 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 ``Research to Accelerate Cures and 
Equity for Children Act'' or the ``RACE for Children Act''.

SEC. 2. REQUIRED PEDIATRIC ASSESSMENTS.

    (a) Molecular Targets Regarding Cancer Drugs.--Section 505B of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended--
            (1) in subsection (a)(1)--
                    (A) in subparagraph (A), by striking ``or'' at the 
                end;
                    (B) in subparagraph (B), by inserting ``or'' after 
                ``administration,''; and
                    (C) by inserting after subparagraph (B) the 
                following:
                    ``(C) under section 505 of this Act or section 351 
                of the Public Health Service Act, as described in 
                subparagraph (A) or (B), that is directed at a 
                molecular target present in one or more cancers in one 
                or more pediatric populations,''; and
            (2) in subsection (b)(1)--
                    (A) by amending subparagraph (A)(i) to read as 
                follows:
                    ``(A)(i) the drug or biological product is used for 
                a substantial number of pediatric patients--
                            ``(I) for the labeled indications; or
                            ``(II) with respect to 1 or more specific 
                        molecular targets present in cancers in 
                        pediatric populations; and'';
                    (B) by amending subparagraph (B) to read as 
                follows:
                    ``(B) there is reason to believe that the drug or 
                biological product would represent a meaningful 
                therapeutic benefit over existing therapies for 
                pediatric patients--
                            ``(i) for 1 or more of the claimed 
                        indications; or
                            ``(ii) with respect to 1 or more specific 
                        molecular targets present in cancers in 
                        pediatric populations; or''; and
                    (C) by amending paragraph (2) of subsection (c) to 
                read as follows:
            ``(2) the drug or biological product is in a class of 
        products, is for an indication, or is directed at a specific 
        molecular target present in cancers in pediatric populations, 
        for which there is need for additional options.''.
    (b) Early Meeting on Pediatric Study Plan.--
            (1) In general.--Clause (i) of section 505B(e)(2)(C) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) 
        is amended to read as follows:
                            ``(i) shall meet with the applicant--
                                    ``(I) if requested by the applicant 
                                with respect to a drug that is directed 
                                at a molecular target that is present 
                                in one or more cancers in one or more 
                                pediatric populations, as described in 
                                subsection (a)(1)(C), to discuss, not 
                                later than the end-of-Phase 1 meeting 
                                (as such term is used in section 
                                312.82(b) of title 21, Code of Federal 
                                Regulations, or successor regulations), 
                                preparation of the initial pediatric 
                                study plan;
                                    ``(II) to discuss the initial 
                                pediatric study plan as soon as 
                                practicable, but not later than 90 
                                calendar days after the receipt of such 
                                plan under subparagraph (A); and
                                    ``(III) to discuss any scientific 
                                or operational challenges that may be 
                                the basis of a deferral under 
                                subsection (a)(3) or a full or partial 
                                waiver under subsection (a)(4);''.
            (2) Conforming changes.--Section 505B(e) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended--
                    (A) in the heading of paragraph (2), by striking 
                ``meeting'' and inserting ``meetings'';
                    (B) in the heading of paragraph (2)(C), by striking 
                ``Meeting'' and inserting ``Meetings'';
                    (C) in clauses (ii) and (iii) of paragraph (2)(C), 
                by striking ``no meeting'' each place it appears and 
                inserting ``no meeting under clause (i)(II)''; and
                    (D) in paragraph (3) by striking ``meeting under 
                paragraph (2)(C)(i)'' and inserting ``meeting under 
                paragraph (2)(C)(i)(II)''.
    (c) Orphan Drugs.--Section 505B(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355c(k)) is amended by inserting ``except in 
the case of a drug or biological product that is the subject of an 
application described in subsection (a)(1)(C),'' after ``regulation,''.
    (d) Guidance.--Not later than 1 year after the date of enactment of 
this Act, the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall issue guidance on the 
implementation of this section (including the amendments made by this 
section), including study designs and molecular targets likely to be 
present in one or more cancers in pediatric populations that are 
appropriate for assessment under the amendments made by this Act.
    (e) Applicability.--This Act and the amendments made by this Act 
apply with respect to applications for a drug submitted under section 
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
section 351 of the Public Health Service Act (42 U.S.C. 262) on or 
after the date that is 18 months after the date of enactment of this 
Act.
    (f) Report to Congress.--Not later than July 12, 2021, the 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall submit to Congress a report on the 
implementation of the amendments made by this section, together with 
any recommendations of the Secretary regarding such amendments.
    (g) Rule of Construction.--Nothing in this Act, including the 
amendments made by this Act, shall limit the authority of the Secretary 
of Health and Human Services to issue written requests under section 
505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a).
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