text: 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).''.
target: Promoting Life-Saving New Therapies for Neonates Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to award the sponsor of a new drug or biological product for the treatment of newborns a neonatal drug exclusivity voucher upon approval of the medication. A neonatal drug exclusivity voucher is a transferable voucher for a one-year extension of all existing patents and marketing exclusivities for a brand name medication. For a sponsor to be eligible for a voucher, the new medication must: (1) treat a condition identified in the Priority List of Critical Needs for Neonates required under this Act, and (2) have been studied in newborns. A voucher may be revoked if the new medication is not marketed in the United States within one year of approval. A voucher may not be used: (1) to extend the marketing exclusivity period for a drug for which the FDA requires an assessment of the safety and effectiveness in newborns, or (2) on the same product as a priority review voucher. A sponsor intending to use a voucher must notify the FDA at least 15 months before the expiration of the patents or exclusivity to be extended. The Government Accountability Office must study the effectiveness of this voucher program.
feat_title: Promoting Life-Saving New Therapies for Neonates Act of 2015