II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Promoting Life-Saving 

5 New Therapies for Neonates Act of 2015’’. 

6 SEC. 2. PROMOTING THE DEVELOPMENT OF SAFE AND EF7 FECTIVE THERAPIES FOR NEONATES. 

8 Subchapter B of chapter V of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 360aa et seq.) is 

10 amended by inserting after section 529 the following: 


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1 ‘‘SEC. 530. EXCLUSIVITY TO ENCOURAGE DEVELOPMENT OF 

2 SAFE AND EFFECTIVE THERAPIES FOR NEO3 NATES. 

4 ‘‘(a) DEFINITIONS.—In this section: 

5 ‘‘(1) NEONATAL DRUG.—The term ‘neonatal 

6 drug’ means a drug for the prevention or treatment 

7 of a disease or condition of a preterm or full-term 

8 neonate. 

9 ‘‘(2) NEONATAL DRUG APPLICATION.—The 

10 term ‘neonatal drug application’ means a human 

11 drug application, as defined in section 735(1), 

12 that— 

13 ‘‘(A) is for a drug or biological product— 

14 ‘‘(i) that is for the prevention or 

15 treatment of a disease or condition listed 

16 on the Priority List of Critical Needs for 

17 Neonates described in subsection (c); and 

18 ‘‘(ii) that contains no active ingredient 

19 (including any ester or salt of the active 

20 ingredient) that has been previously ap21 proved in any other application under sec22 tion 505(b)(1), 505(b)(2), or 505(j) of this 

23 Act or section 351(a) or 351(k) of the 

24 Public Health Service Act; 


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1 ‘‘(B) is submitted under section 505(b)(1) 

2 of this Act or section 351(a) of the Public 

3 Health Service Act; 

4 ‘‘(C) the Secretary determines to be eligi5 ble for a neonatal drug exclusivity voucher, in 

6 accordance with subsection (b); 

7 ‘‘(D) relies on clinical data derived from 

8 studies examining a neonatal population and 

9 dosages of the drug intended for that popu10 lation; and 

11 ‘‘(E) is approved after the date of the en12 actment of the Promoting Life-Saving New 

13 Therapies for Neonates Act of 2015. 

14 ‘‘(3) NEONATAL DRUG EXCLUSIVITY VOUCH15 ER.—The term ‘neonatal drug exclusivity voucher’ 

16 means a voucher issued by the Secretary to the 

17 sponsor of a neonatal drug application that entitles 

18 the holder of such voucher to one year of transfer19 able extension of all existing patents and marketing 

20 exclusivities, including any extensions, for a single 

21 human drug with respect to an application sub22 mitted under section 505(b)(1) or for a single 

23 human biologic product with respect to an applica24 tion submitted under section 351(a) of the Public 

25 Health Service Act, including the 6-month period deVerDate Sep 11 2014 22:15 Sep 16, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2041.IS S2041

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1 scribed in section 505A, the 4- and 5-year periods 

2 described in subsections (c)(3)(E)(ii) and 

3 (j)(5)(F)(ii) of section 505, the 3-year periods de4 scribed in clauses (iii) and (iv) of subsection 

5 (c)(3)(E) and clauses (iii) and (iv) of subsection 

6 (j)(5)(F) of section 505, the 7-year period described 

7 in section 527, the 5-year period described in section 

8 505E, and the 12-year period described in section 

9 351(k)(7). 

10 ‘‘(b) NEONATAL DRUG EXCLUSIVITY VOUCHER.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall award 

12 a neonatal drug exclusivity voucher to the sponsor of 

13 a neonatal drug application upon approval by the 

14 Secretary of such neonatal drug application. 

15 ‘‘(2) TRANSFERABILITY.— 

16 ‘‘(A) IN GENERAL.—The sponsor of a neo17 natal drug application that receives a neonatal 

18 drug exclusivity voucher under this section may 

19 transfer (including by sale) the voucher to a 

20 sponsor of a human drug for which an applica21 tion under section 505(b)(1) or section 351 of 

22 the Public Health Service Act has been ap23 proved, will be submitted, or has been sub24 mitted. 


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1 ‘‘(B) NONTRANSFERABILITY.—A neonatal 

2 exclusivity voucher may not be transferred to, 

3 or used for, a drug with respect to which all 

4 patents and exclusivities have expired as of the 

5 date of the transfer. 

6 ‘‘(C) NOTIFICATION OF TRANSFER.—Each 

7 person to whom a voucher is transferred shall 

8 notify the Secretary of such change in owner9 ship of the voucher not later than 30 calendar 

10 days after such transfer. 

11 ‘‘(D) PROHIBITION ON ADDITIONAL

12 FEES.—The Secretary shall not apply a fee for 

13 the exercise of a voucher under this section. 

14 The preceding sentence shall not affect the au15 thority of the Secretary to apply fees with re16 spect to a neonatal drug application that are 

17 otherwise applicable under law. 

18 ‘‘(E) REVOCATION OF VOUCHER.—The 

19 Secretary may revoke any neonatal exclusivity 

20 voucher if the neonatal drug product for which 

21 such voucher was awarded is not marketed in 

22 the United States within the 365-day period be23 ginning on the date of the approval of such 

24 drug under section 505 of this Act or section 

25 351 of the Public Health Service Act. 


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1 ‘‘(3) LIMITATIONS.— 

2 ‘‘(A) NO AWARD FOR PRIOR APPROVED AP3 PLICATION.—A sponsor of a neonatal drug may 

4 not receive a voucher under this section if the 

5 neonatal drug application was submitted to the 

6 Secretary prior to the date of enactment of this 

7 section. 

8 ‘‘(B) REQUIRED PEDIATRIC RESEARCH.— 

9 The Secretary shall limit grants of exclusivity 

10 under this section to drugs that are not re11 quired to complete neonatal studies under sec12 tion 505B. 

13 ‘‘(C) NO COMBINING VOUCHERS.—A spon14 sor may not use a neonatal exclusivity voucher 

15 on a product for which the sponsor also intends 

16 to use a voucher obtained or purchased pursu17 ant to section 524 or section 529. 

18 ‘‘(4) NOTIFICATION OF INTENT TO USE VOUCH19 ER.— 

20 ‘‘(A) NOTIFICATION BY SPONSOR.—The 

21 sponsor of a human drug application intending 

22 to use a voucher awarded or transferred under 

23 this section shall notify the Secretary not later 

24 than 15 months prior to loss of patent and 

25 exclusivities on the drug for which the voucher 


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1 will be redeemed, in such form as the Secretary 

2 may require. 

3 ‘‘(B) NOTIFICATION BY SECRETARY.— 

4 Within 30 calendar days of such notification to 

5 the Secretary, the Secretary shall notify the 

6 sponsor of its eligibility to redeem a voucher for 

7 the intended drug. 

8 ‘‘(c) PRIORITY LIST OF CRITICAL NEEDS FOR NEO9 NATES.— 

10 ‘‘(1) IN GENERAL.—The Secretary, in consulta11 tion with the Pediatric Advisory Committee, the Na12 tional Institutes of Health, the International Neo13 natal Consortium sponsored by Critical Path Insti14 tute, and other stakeholders, shall, within one year 

15 of the date of enactment of the Promoting Life-Sav16 ing New Therapies for Neonates Act of 2015— 

17 ‘‘(A) develop and publish a list of critical 

18 research priorities related to specific diseases or 

19 conditions common to the neonatal population 

20 (referred to as the ‘Priority List of Critical 

21 Needs for Neonates’); 

22 ‘‘(B) issue guidance specific to the neo23 natal drug exclusivity voucher program; and 

24 ‘‘(C) perform other activities necessary to 

25 support neonatal drug applications. 


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1 ‘‘(2) PUBLIC COMMENT.—The Secretary shall 

2 provide a period of public notice and comment on 

3 the proposed list and shall hold public meetings to 

4 elicit input from patient advocacy and other organi5 zations prior to publishing the final list. 

6 ‘‘(3) SUBSEQUENT UPDATE.—The Secretary 

7 may revise, and publish in accordance with para8 graph (1)(A), the Priority List of Critical Needs for 

9 Neonates every 3 years, or as frequently as the Sec10 retary determines necessary. 

11 ‘‘(4) RESTRICTION ON REMOVAL FROM LIST.— 

12 No disease or condition on the Priority List of Crit13 ical Needs for Neonates may be removed until after 

14 completion of the study and report under subsection 

15 (d). 

16 ‘‘(d) GAO STUDY AND REPORT.— 

17 ‘‘(1) STUDY.— 

18 ‘‘(A) IN GENERAL.—Beginning 8 years 

19 after the date of enactment of the Promoting 

20 Life-Saving New Therapies for Neonates Act of 

21 2015 or on the date that the Secretary awards 

22 the third neonatal exclusivity voucher under 

23 this section, whichever is earlier, the Comp24 troller General of the United States shall con25 duct a study of the effectiveness of the program 


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1 under this section for the development of 

2 human drugs to treat and prevent diseases or 

3 conditions in the neonatal population. 

4 ‘‘(B) CONTENTS OF THE STUDY.—In con5 ducting the study under subparagraph (A), the 

6 Comptroller General shall examine the fol7 lowing: 

8 ‘‘(i) The number of neonatal drug 

9 vouchers awarded under this section. 

10 ‘‘(ii) The indications for each drug for 

11 which a neonatal exclusivity voucher was 

12 approved under section 505 or section 351 

13 of the Public Health Service Act, and 

14 whether any other drugs with indications 

15 for populations other than neonates were 

16 approved with an indication for neonates 

17 under those sections. 

18 ‘‘(iii) Whether, and to what extent, an 

19 unmet need related to the treatment or 

20 prevention of a disease or condition that 

21 affects the neonatal population was met 

22 through the approval of a neonatal drug. 

23 ‘‘(iv) The value of the neonatal exclu24 sivity voucher if transferred. 


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1 ‘‘(v) Identification of each drug for 

2 which a neonatal exclusivity voucher was 

3 used. 

4 ‘‘(vi) The length of the period of time 

5 between the date on which a neonatal ex6 clusivity voucher was awarded and the date 

7 on which it was used. 

8 ‘‘(2) REPORT.—Not later than 1 year after the 

9 date under paragraph (1)(A), the Comptroller Gen10 eral shall submit to the Committee on Health, Edu11 cation, Labor, and Pensions of the Senate and the 

12 Committee on Energy and Commerce of the House 

13 of Representatives a report containing the results of 

14 the study under paragraph (1).’’. 

Æ 


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