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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2041 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 2041

         To promote the development of safe drugs for neonates.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           September 16, 2015

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

_______________________________________________________________________

                                 A BILL

 
         To promote the development of safe drugs for neonates.

    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 ``Promoting Life-Saving New Therapies 
for Neonates Act of 2015''.

SEC. 2. PROMOTING THE DEVELOPMENT OF SAFE AND EFFECTIVE THERAPIES FOR 
              NEONATES.

    Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360aa et seq.) is amended by inserting after section 529 
the following:

``SEC. 530. EXCLUSIVITY TO ENCOURAGE DEVELOPMENT OF SAFE AND EFFECTIVE 
              THERAPIES FOR NEONATES.

    ``(a) Definitions.--In this section:
            ``(1) Neonatal drug.--The term `neonatal drug' means a drug 
        for the prevention or treatment of a disease or condition of a 
        preterm or full-term neonate.
            ``(2) Neonatal drug application.--The term `neonatal drug 
        application' means a human drug application, as defined in 
        section 735(1), that--
                    ``(A) is for a drug or biological product--
                            ``(i) that is for the prevention or 
                        treatment of a disease or condition listed on 
                        the Priority List of Critical Needs for 
                        Neonates described in subsection (c); and
                            ``(ii) that contains no active ingredient 
                        (including any ester or salt of the active 
                        ingredient) that has been previously approved 
                        in any other application under section 
                        505(b)(1), 505(b)(2), or 505(j) of this Act or 
                        section 351(a) or 351(k) of the Public Health 
                        Service Act;
                    ``(B) is submitted under section 505(b)(1) of this 
                Act or section 351(a) of the Public Health Service Act;
                    ``(C) the Secretary determines to be eligible for a 
                neonatal drug exclusivity voucher, in accordance with 
                subsection (b);
                    ``(D) relies on clinical data derived from studies 
                examining a neonatal population and dosages of the drug 
                intended for that population; and
                    ``(E) is approved after the date of the enactment 
                of the Promoting Life-Saving New Therapies for Neonates 
                Act of 2015.
            ``(3) Neonatal drug exclusivity voucher.--The term 
        `neonatal drug exclusivity voucher' means a voucher issued by 
        the Secretary to the sponsor of a neonatal drug application 
        that entitles the holder of such voucher to one year of 
        transferable extension of all existing patents and marketing 
        exclusivities, including any extensions, for a single human 
        drug with respect to an application submitted under section 
        505(b)(1) or for a single human biologic product with respect 
        to an application submitted under section 351(a) of the Public 
        Health Service Act, including the 6-month period described in 
        section 505A, the 4- and 5-year periods described in 
        subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 
        3-year periods described in clauses (iii) and (iv) of 
        subsection (c)(3)(E) and clauses (iii) and (iv) of subsection 
        (j)(5)(F) of section 505, the 7-year period described in 
        section 527, the 5-year period described in section 505E, and 
        the 12-year period described in section 351(k)(7).
    ``(b) Neonatal Drug Exclusivity Voucher.--
            ``(1) In general.--The Secretary shall award a neonatal 
        drug exclusivity voucher to the sponsor of a neonatal drug 
        application upon approval by the Secretary of such neonatal 
        drug application.
            ``(2) Transferability.--
                    ``(A) In general.--The sponsor of a neonatal drug 
                application that receives a neonatal drug exclusivity 
                voucher under this section may transfer (including by 
                sale) the voucher to a sponsor of a human drug for 
                which an application under section 505(b)(1) or section 
                351 of the Public Health Service Act has been approved, 
                will be submitted, or has been submitted.
                    ``(B) Nontransferability.--A neonatal exclusivity 
                voucher may not be transferred to, or used for, a drug 
                with respect to which all patents and exclusivities 
                have expired as of the date of the transfer.
                    ``(C) Notification of transfer.--Each person to 
                whom a voucher is transferred shall notify the 
                Secretary of such change in ownership of the voucher 
                not later than 30 calendar days after such transfer.
                    ``(D) Prohibition on additional fees.--The 
                Secretary shall not apply a fee for the exercise of a 
                voucher under this section. The preceding sentence 
                shall not affect the authority of the Secretary to 
                apply fees with respect to a neonatal drug application 
                that are otherwise applicable under law.
                    ``(E) Revocation of voucher.--The Secretary may 
                revoke any neonatal exclusivity voucher if the neonatal 
                drug product for which such voucher was awarded is not 
                marketed in the United States within the 365-day period 
                beginning on the date of the approval of such drug 
                under section 505 of this Act or section 351 of the 
                Public Health Service Act.
            ``(3) Limitations.--
                    ``(A) No award for prior approved application.--A 
                sponsor of a neonatal drug may not receive a voucher 
                under this section if the neonatal drug application was 
                submitted to the Secretary prior to the date of 
                enactment of this section.
                    ``(B) Required pediatric research.--The Secretary 
                shall limit grants of exclusivity under this section to 
                drugs that are not required to complete neonatal 
                studies under section 505B.
                    ``(C) No combining vouchers.--A sponsor may not use 
                a neonatal exclusivity voucher on a product for which 
                the sponsor also intends to use a voucher obtained or 
                purchased pursuant to section 524 or section 529.
            ``(4) Notification of intent to use voucher.--
                    ``(A) Notification by sponsor.--The sponsor of a 
                human drug application intending to use a voucher 
                awarded or transferred under this section shall notify 
                the Secretary not later than 15 months prior to loss of 
                patent and exclusivities on the drug for which the 
                voucher will be redeemed, in such form as the Secretary 
                may require.
                    ``(B) Notification by secretary.--Within 30 
                calendar days of such notification to the Secretary, 
                the Secretary shall notify the sponsor of its 
                eligibility to redeem a voucher for the intended drug.
    ``(c) Priority List of Critical Needs for Neonates.--
            ``(1) In general.--The Secretary, in consultation with the 
        Pediatric Advisory Committee, the National Institutes of 
        Health, the International Neonatal Consortium sponsored by 
        Critical Path Institute, and other stakeholders, shall, within 
        one year of the date of enactment of the Promoting Life-Saving 
        New Therapies for Neonates Act of 2015--
                    ``(A) develop and publish a list of critical 
                research priorities related to specific diseases or 
                conditions common to the neonatal population (referred 
                to as the `Priority List of Critical Needs for 
                Neonates');
                    ``(B) issue guidance specific to the neonatal drug 
                exclusivity voucher program; and
                    ``(C) perform other activities necessary to support 
                neonatal drug applications.
            ``(2) Public comment.--The Secretary shall provide a period 
        of public notice and comment on the proposed list and shall 
        hold public meetings to elicit input from patient advocacy and 
        other organizations prior to publishing the final list.
            ``(3) Subsequent update.--The Secretary may revise, and 
        publish in accordance with paragraph (1)(A), the Priority List 
        of Critical Needs for Neonates every 3 years, or as frequently 
        as the Secretary determines necessary.
            ``(4) Restriction on removal from list.--No disease or 
        condition on the Priority List of Critical Needs for Neonates 
        may be removed until after completion of the study and report 
        under subsection (d).
    ``(d) GAO Study and Report.--
            ``(1) Study.--
                    ``(A) In general.--Beginning 8 years after the date 
                of enactment of the Promoting Life-Saving New Therapies 
                for Neonates Act of 2015 or on the date that the 
                Secretary awards the third neonatal exclusivity voucher 
                under this section, whichever is earlier, the 
                Comptroller General of the United States shall conduct 
                a study of the effectiveness of the program under this 
                section for the development of human drugs to treat and 
                prevent diseases or conditions in the neonatal 
                population.
                    ``(B) Contents of the study.--In conducting the 
                study under subparagraph (A), the Comptroller General 
                shall examine the following:
                            ``(i) The number of neonatal drug vouchers 
                        awarded under this section.
                            ``(ii) The indications for each drug for 
                        which a neonatal exclusivity voucher was 
                        approved under section 505 or section 351 of 
                        the Public Health Service Act, and whether any 
                        other drugs with indications for populations 
                        other than neonates were approved with an 
                        indication for neonates under those sections.
                            ``(iii) Whether, and to what extent, an 
                        unmet need related to the treatment or 
                        prevention of a disease or condition that 
                        affects the neonatal population was met through 
                        the approval of a neonatal drug.
                            ``(iv) The value of the neonatal 
                        exclusivity voucher if transferred.
                            ``(v) Identification of each drug for which 
                        a neonatal exclusivity voucher was used.
                            ``(vi) The length of the period of time 
                        between the date on which a neonatal 
                        exclusivity voucher was awarded and the date on 
                        which it was used.
            ``(2) Report.--Not later than 1 year after the date under 
        paragraph (1)(A), the Comptroller General shall submit to the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives a report containing the results of the study 
        under paragraph (1).''.
                                 <all>
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