[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6664 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 6664

To encourage innovation in the development of pediatric drugs, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            December 7, 2023

 Ms. Eshoo (for herself and Mr. McCaul) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To encourage innovation in the development of pediatric drugs, 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 ``Innovation in Pediatric Drugs Act of 
2023''.

SEC. 2. PEDIATRIC STUDIES OF ORPHAN DRUGS.

    (a) Application of Pediatric Research Requirements to Orphan 
Drugs.--
            (1) In general.--Section 505B of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355c) is amended by striking 
        subsection (k).
            (2) Applicability.--The amendment made by paragraph (1) 
        applies only to applications described in subparagraph (A) or 
        (B) of section 505B(a)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355c(a)(1)) that are submitted on or 
        after the date that is 18 months after the date of enactment of 
        this Act.
    (b) Guidance.--The Secretary of Health and Human Services (referred 
to in this Act as the ``Secretary'') shall--
            (1) not later than 6 months after the date of enactment of 
        this Act, issue draft guidance describing how, upon the 
        applicability of the amendment made by subsection (a)(1), the 
        requirements of section 505B of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355c) will apply with respect to any 
        drug or biological product for an indication for which orphan 
        designation has been granted under section 526 of such Act (21 
        U.S.C. 360bb); and
            (2) not later than 18 months after the date of enactment of 
        this Act, finalize such draft guidance.
    (c) Content of Guidance.--The guidance under subsection (b) shall 
address the following:
            (1) Information regarding how full and partial waivers 
        under subsections (a)(5)(A), (a)(5)(B), and (b)(2) of section 
        505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355c) for any drug or biological product for an indication for 
        which orphan designation has been granted under section 526 of 
        such Act (21 U.S.C. 360bb) will be granted (including a 
        description of impossible or highly impracticable studies for 
        indications for which orphan designation has been granted under 
        such section 526).
            (2) Application of the requirements of section 505B(e) of 
        such Act (21 U.S.C. 355c(e)) to drugs or biological products 
        for an indication for which orphan designation has been granted 
        under section 526 of such Act (21 U.S.C. 360bb), including 
        submission and timing of planned requests for full or partial 
        waivers and responses by the Food and Drug Administration to 
        those requests.
            (3) Process for regularly updating conditions that 
        automatically qualify for a waiver under subsection (a)(5)(A) 
        or (b)(2)(A) of section 505B of such Act (21 U.S.C. 355c).
            (4) Situations where the initial pediatric study plan under 
        section 505B(e) of such Act (21 U.S.C. 355c(e)) includes a plan 
        to study the drug or biological product in all relevant 
        pediatric age groups.
            (5) Consideration of how the Secretary of Health and Human 
        Services will balance the unique scientific challenges of rare 
        disease drug development with the need for improved pediatric 
        labeling of drugs and biological products for indications for 
        which orphan designation has been granted under section 526 of 
        such Act (21 U.S.C. 360bb).
            (6) Applicability of real-world evidence in the fulfillment 
        of requirements under section 505B of such Act (21 U.S.C. 
        355c).
            (7) Consideration of input received from the public meeting 
        set forth in subsection (d).
    (d) Public Meeting.--The Secretary shall--
            (1) not later than 1 year after the date of enactment of 
        this Act, hold a public meeting to inform the final guidance to 
        be issued under subsection (b)(2); and
            (2) publish prior notice of such meeting in the Federal 
        Register.
    (e) GAO Study.--Not later than 4 years after the date of enactment 
of this Act, the Comptroller General of the United States shall submit 
to the Committee on Energy and Commerce and the Committee on Ways and 
Means of the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report that--
            (1) addresses the impacts of this Act on--
                    (A) rare disease drug development in the United 
                States; and
                    (B) the increased availability of pediatric 
                information on drugs and biological products for 
                indications for which orphan designation has been 
                granted under section 526 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360bb); and
            (2) includes--
                    (A) the findings of a survey of companies of 
                varying sizes engaged in the development of orphan 
                drugs; and
                    (B) input from patient groups and medical provider 
                associations.
    (f) Rule of Construction.--Nothing in this section shall be 
construed to limit requirements for investigations, as described in 
section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c(a)(3)), of molecularly targeted pediatric cancer drugs for 
which orphan designation has been granted under section 526 of such Act 
(21 U.S.C. 360bb).

SEC. 3. REAUTHORIZING THE 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 in paragraph (1) by striking ``$25,000,000 for 
each of fiscal years 2023 through 2027'' and inserting ``$50,000,000 
for each of fiscal years 2023 through 2027''.

SEC. 4. ENSURING COMPLETION OF PEDIATRIC STUDY REQUIREMENTS.

    (a) Equal Accountability for Pediatric Study Requirements.--Section 
505B(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c(d)(2)) is amended by striking ``(except that the drug or 
biological product shall not be subject to action under section 303)''.
    (b) 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''.
    (c) Transition Rule.--The Secretary of Health and Human Services 
shall take no enforcement actions under section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333) for failures described in 
section 505B(d) of such Act (21 U.S.C. 355c(d)) before the date this is 
180 days after the date of enactment of this Act.

SEC. 5. 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 assessment of the 
        appropriateness of deferrals and deferral extensions granted 
        for such products and an evaluation of compliance with 
        deadlines provided for in such 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 
        for failure to comply with requirements under section 505B of 
        such Act, 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.''.
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