II 

112TH CONGRESS 

2D SESSION S. 2289 

To amend the Federal Food, Drug, and Cosmetic Act with respect to pediatric 

provisions. 

IN THE SENATE OF THE UNITED STATES 

APRIL 17, 2012 

Mr. REED (for himself, Mr. ALEXANDER, Mrs. MURRAY, and Mr. ROBERTS) 

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 with 

respect to pediatric provisions. 

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 ‘‘Better Pharma5 ceuticals and Devices for Children Act of 2012’’. 

6 SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. 

7 (a) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents; references in Act. 

Sec. 3. Permanence. 

Sec. 4. Written requests. 


tkelley on DSK3SPTVN1PROD with BILLS
2 

•S 2289 IS

Sec. 5. Communication with Pediatric Review Committee. 

Sec. 6. Access to data. 

Sec. 7. Ensuring the completion of pediatric studies. 

Sec. 8. Pediatric study plans. 

Sec. 9. Reauthorizations. 

Sec. 10. Report. 

Sec. 11. Technical amendments. 

1 (b) REFERENCES IN ACT.—Except as otherwise spec2 ified, amendments made by this Act to a section or other 

3 provision of law are amendments to such section or other 

4 provision of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 301 et seq.). 

6 SEC. 3. PERMANENCE. 

7 (a) PEDIATRIC STUDIES OF DRUGS.—Subsection (q) 

8 of section 505A (21 U.S.C. 355a) is amended— 

9 (1) in paragraph (1), by striking ‘‘on or before 

10 October 1, 2012,’’; and 

11 (2) in paragraph (2), by striking ‘‘on or before 

12 October 1, 2012,’’. 

13 (b) RESEARCH INTO PEDIATRIC USES FOR DRUGS

14 AND BIOLOGICAL PRODUCTS.—Section 505B (21 U.S.C. 

15 355c) is amended— 

16 (1) by striking subsection (m); and 

17 (2) by redesignating subsection (n) as sub18 section (m). 

19 SEC. 4. WRITTEN REQUESTS. 

20 (a) FEDERAL FOOD, DRUG, AND COSMETIC ACT.— 

21 Subsection (h) of section 505A (21 U.S.C. 355a) is 

22 amended to read as follows: 


tkelley on DSK3SPTVN1PROD with BILLS
3 

•S 2289 IS

1 ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE2 QUIREMENTS.—Exclusivity under this section shall only be 

3 granted for the completion of a study or studies that are 

4 the subject of a written request and for which reports are 

5 submitted and accepted in accordance with subsection 

6 (d)(3). Written requests under this section may consist of 

7 a study or studies required under section 505B.’’. 

8 (b) PUBLIC HEALTH SERVICE ACT.—Section 351(m) 

9 of the Public Health Service Act (42 U.S.C. 262(m)) is 

10 amended by striking ‘‘(f), (i), (j), (k), (l), (p), and (q)’’ 

11 and inserting ‘‘(f), (h), (i), (j), (k), (l), and (p)’’. 

12 SEC. 5. COMMUNICATION WITH PEDIATRIC REVIEW COM13 MITTEE. 

14 Not later than 1 year after the date of enactment 

15 of this Act, the Secretary of Health and Human Services 

16 (referred to in this Act as the ‘‘Secretary’’) shall issue in17 ternal standard operating procedures that provide for the 

18 review by the internal review committee established under 

19 section 505C of the Federal Food, Drug, and Cosmetic 

20 Act (21 U.S.C. 355d) of any significant modifications to 

21 initial pediatric study plans, agreed pediatric study plans, 

22 and written requests under sections 505A and 505B of 

23 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

24 355c). Such internal standard operating procedures shall 


tkelley on DSK3SPTVN1PROD with BILLS
4 

•S 2289 IS

1 be made publicly available on the Internet Web site of the 

2 Food and Drug Administration. 

3 SEC. 6. ACCESS TO DATA. 

4 Not later than 3 years after the date of enactment 

5 of this Act, the Secretary shall make available to the pub6 lic, including through posting on the Internet Web site of 

7 the Food and Drug Administration, the medical, statis8 tical, and clinical pharmacology reviews of, and cor9 responding written requests issued to an applicant, spon10 sor, or holder for, pediatric studies submitted between 

11 January 4, 2002, and September 27, 2007, under sub12 section (b) or (c) of section 505A of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 

14 months of market exclusivity was granted and that re15 sulted in a labeling change. The Secretary shall make pub16 lic the information described in the preceding sentence in 

17 a manner consistent with how the Secretary releases infor18 mation under section 505A(k) of the Federal Food, Drug, 

19 and Cosmetic Act (21 U.S.C. 355a(k)). 

20 SEC. 7. ENSURING THE COMPLETION OF PEDIATRIC STUD21 IES. 

22 (a) EXTENSION OF DEADLINE FOR DEFERRED

23 STUDIES.—Section 505B (21 U.S.C. 355c) is amended— 

24 (1) in subsection (a)(3)— 


tkelley on DSK3SPTVN1PROD with BILLS
5 

•S 2289 IS

1 (A) by redesignating subparagraph (B) as 

2 subparagraph (C); 

3 (B) by inserting after subparagraph (A) 

4 the following: 

5 ‘‘(B) DEFERRAL EXTENSION.— 

6 ‘‘(i) IN GENERAL.—On the initiative 

7 of the Secretary or at the request of the 

8 applicant, the Secretary may grant an ex9 tension of a deferral approved under sub10 paragraph (A) for submission of some or 

11 all assessments required under paragraph 

12 (1) if— 

13 ‘‘(I) the Secretary determines 

14 that the conditions described in sub15 clause (II) or (III) of subparagraph 

16 (A)(i) continue to be met; and 

17 ‘‘(II) the applicant submits a new 

18 timeline under subparagraph 

19 (A)(ii)(IV) and any significant up20 dates to the information required 

21 under subparagraph (A)(ii). 

22 ‘‘(ii) TIMING AND INFORMATION.—If 

23 the deferral extension under this subpara24 graph is requested by the applicant, the 

25 applicant shall submit the deferral extenVerDate Mar 15 2010 21:40 Apr 18, 2012 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2289.IS S2289

tkelley on DSK3SPTVN1PROD with BILLS
6 

•S 2289 IS

1 sion request containing the information de2 scribed in this subparagraph not less than 

3 90 days prior to the date that the deferral 

4 would expire but for the requested exten5 sion. The Secretary shall respond to such 

6 request not later than 45 days after the re7 ceipt of such letter. If the Secretary grants 

8 such an extension, the specified date shall 

9 be considered the extended date. The spon10 sor of the required assessment under para11 graph (1) shall not be issued a letter de12 scribed in subsection (d) unless the speci13 fied date of submission for such required 

14 studies has passed or if the request for an 

15 extension is pending. For a deferral that 

16 has expired prior to the date of enactment 

17 of the Better Pharmaceuticals and Devices 

18 for Children Act of 2012 or that will expire 

19 prior to 270 days after the date of enact20 ment of such Act, a deferral extension 

21 shall be requested by an applicant not later 

22 than 180 days after the date of enactment 

23 of such Act. Nothing in this clause shall 

24 prevent the Secretary from updating the 

25 status of a study or studies publicly if 


tkelley on DSK3SPTVN1PROD with BILLS
7 

•S 2289 IS

1 components of such study or studies are 

2 late or delayed.’’; and 

3 (C) in subparagraph (C), as so redesig4 nated— 

5 (i) in clause (i), by adding at the end 

6 the following: 

7 ‘‘(III) Projected completion date 

8 for pediatric studies. 

9 ‘‘(IV) The reason or reasons why 

10 a deferral or deferral extension con11 tinues to be necessary.’’; and 

12 (ii) in clause (ii)— 

13 (I) by inserting ‘‘, as well as the 

14 date of each deferral or deferral ex15 tension, as applicable,’’ after ‘‘clause 

16 (i)’’; and 

17 (II) by inserting ‘‘not later than 

18 60 days after submission to the Sec19 retary’’ after ‘‘Administration’’; and 

20 (2) in subsection (f)— 

21 (A) in the subsection heading, by inserting 

22 ‘‘DEFERRAL EXTENSIONS,’’ after ‘‘DEFER23 RALS,’’; 

24 (B) in paragraph (1), by inserting ‘‘, defer25 ral extension,’’ after ‘‘deferral’’; and 


tkelley on DSK3SPTVN1PROD with BILLS
8 

•S 2289 IS

1 (C) in paragraph (4), by inserting ‘‘, defer2 ral extensions,’’ after ‘‘deferrals’’. 

3 (b) TRACKING OF EXTENSIONS; ANNUAL INFORMA4 TION.—Section 505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) 

5 is amended to read as follows: 

6 ‘‘(D) aggregated on an annual basis— 

7 ‘‘(i) the total number of deferrals and 

8 deferral extensions requested and granted 

9 under this section and, if granted, the rea10 sons for each such deferral or deferral ex11 tension; 

12 ‘‘(ii) the timeline for completion of the 

13 assessments; and 

14 ‘‘(iii) the number of assessments com15 pleted and pending by the specified date, 

16 as outlined in subsection (a)(3);’’. 

17 (c) ACTION ON FAILURE TO COMPLETE STUDIES.— 

18 (1) ISSUANCE OF LETTER.—Subsection (d) of 

19 section 505B (21 U.S.C. 355c) is amended to read 

20 as follows: 

21 ‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person 

22 fails to submit a required assessment described in sub23 section (a)(2), fails to meet the applicable requirements 

24 in subsection (a)(3), or fails to submit a request for ap25 proval of a pediatric formulation described in subsection 


tkelley on DSK3SPTVN1PROD with BILLS
9 

•S 2289 IS

1 (a) or (b), in accordance with applicable provisions of sub2 sections (a) and (b), the following shall apply: 

3 ‘‘(1) Beginning 270 days after the date of en4 actment of the Better Pharmaceuticals and Devices 

5 for Children Act of 2012, the Secretary shall issue 

6 a letter to such person informing them of such fail7 ure to submit or meet the applicable subsection. 

8 Such letter shall require the person to respond in 

9 writing within 45 calendar days of issuance of such 

10 letter. Such response may include the person’s re11 quest for a deferral extension if applicable. Such let12 ter and the person’s written response to such letter 

13 shall be made publicly available on the Internet Web 

14 site of the Food and Drug Administration 45 cal15 endar days after issuance, with redactions for any 

16 trade secrets and confidential commercial informa17 tion. If the Secretary determines that the letter was 

18 issued in error, the requirements of this paragraph 

19 shall not apply. 

20 ‘‘(2) The drug or biological product that is the 

21 subject of an assessment described in subsection 

22 (a)(2), applicable requirements in subsection (a)(3), 

23 or request for approval of a pediatric formulation, 

24 may be considered misbranded solely because of that 

25 failure and subject to relevant enforcement action 


tkelley on DSK3SPTVN1PROD with BILLS
10 

•S 2289 IS

1 (except that the drug or biological product shall not 

2 be subject to action under section 303), but such 

3 failure shall not be the basis for a proceeding— 

4 ‘‘(A) to withdraw approval for a drug 

5 under section 505(e); or 

6 ‘‘(B) to revoke the license for a biological 

7 product under section 351 of the Public Health 

8 Service Act.’’. 

9 (2) TRACKING OF LETTERS ISSUED.—Subpara10 graph (D) of section 505B(f)(6) (21 U.S.C. 

11 355c(f)(6)), as amended by subsection (b), is further 

12 amended— 

13 (A) in clause (ii), by striking ‘‘; and’’ and 

14 inserting a semicolon; 

15 (B) in clause (iii), by adding ‘‘and’’ at the 

16 end; and 

17 (C) by adding at the end the following: 

18 ‘‘(iv) the number of postmarket non19 compliance letters issued pursuant to sub20 section (d), and the recipients of such let21 ters;’’. 

22 SEC. 8. PEDIATRIC STUDY PLANS. 

23 (a) IN GENERAL.—Subsection (e) of section 505B 

24 (21 U.S.C. 355c) is amended to read as follows: 

25 ‘‘(e) PEDIATRIC STUDY PLANS.— 


tkelley on DSK3SPTVN1PROD with BILLS
11 

•S 2289 IS

1 ‘‘(1) IN GENERAL.—An applicant subject to 

2 subsection (a) shall submit to the Secretary an ini3 tial pediatric study plan prior to the submission of 

4 the assessments described under subsection (a)(2). 

5 ‘‘(2) TIMING; CONTENT; MEETING.— 

6 ‘‘(A) TIMING.—An applicant shall submit 

7 an initial pediatric study plan to the Secretary 

8 not later than 60 calendar days after the date 

9 of the end of phase II meeting or such other 

10 equivalent time agreed upon between the Sec11 retary and the applicant. Nothing in this para12 graph shall preclude the Secretary from accept13 ing the submission of an initial pediatric study 

14 plan earlier than the date described under the 

15 preceding sentence. 

16 ‘‘(B) CONTENT OF INITIAL PLAN.—The 

17 initial pediatric study plan shall include— 

18 ‘‘(i) an outline of the pediatric study 

19 or studies that the applicant plans to con20 duct (including, to the extent practicable 

21 study objectives and design, age groups, 

22 relevant endpoints, and statistical ap23 proach); 

24 ‘‘(ii) any request for a deferral, partial 

25 waiver, or waiver under this section, if apVerDate Mar 15 2010 21:40 Apr 18, 2012 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2289.IS S2289

tkelley on DSK3SPTVN1PROD with BILLS
12 

•S 2289 IS

1 plicable, along with any supporting infor2 mation; and 

3 ‘‘(iii) other information specified in 

4 the regulations promulgated under para5 graph (4). 

6 ‘‘(C) MEETING.—The Secretary— 

7 ‘‘(i) shall meet with the applicant to 

8 discuss the initial pediatric study plan not 

9 later than 60 calendar days after the re10 ceipt of such plan under subparagraph (A); 

11 ‘‘(ii) may determine that a written re12 sponse to the initial pediatric study plan is 

13 sufficient to communicate comments on the 

14 initial pediatric study plan, and that no 

15 meeting is necessary; and 

16 ‘‘(iii) if the Secretary determines that 

17 no meeting is necessary, shall so notify the 

18 applicant and provide written comments of 

19 the Secretary not later than 60 calendar 

20 days after the receipt of the initial pedi21 atric study plan. 

22 ‘‘(3) AGREED PEDIATRIC STUDY PLAN.—The 

23 applicant shall document agreement on the initial 

24 pediatric study plan in a submission to the Secretary 

25 marked ‘Agreed Pediatric Study Plan’, and the SecVerDate Mar 15 2010 21:40 Apr 18, 2012 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2289.IS S2289

tkelley on DSK3SPTVN1PROD with BILLS
13 

•S 2289 IS

1 retary shall confirm such agreement to the applicant 

2 in writing not later than 30 calendar days of receipt 

3 of such agreed pediatric study plan. 

4 ‘‘(4) DEFERRAL AND WAIVER.—If the agreed 

5 pediatric study plan contains a request from the ap6 plicant for a deferral, partial waiver, or waiver under 

7 this section, the written confirmation under para8 graph (3) shall include a recommendation from the 

9 Secretary as to whether such request meets the 

10 standards under paragraphs (3) or (4) of subsection 

11 (a). 

12 ‘‘(5) AMENDMENTS TO THE PLAN.—At the ini13 tiative of the Secretary or the applicant, the agreed 

14 pediatric study plan may be amended at any time. 

15 The requirements of paragraph (2)(C) shall apply to 

16 any such proposed amendment in the same manner 

17 and to the same extent as such requirements apply 

18 to an initial pediatric study plan under paragraph 

19 (1). The requirements of paragraphs (3) and (4) 

20 shall apply to any agreement resulting from such 

21 proposed amendment in the same manner and to the 

22 same extent as such requirements apply to an 

23 agreed pediatric study plan. 

24 ‘‘(6) INTERNAL COMMITTEE.—The Secretary 

25 shall consult the internal committee under section 


tkelley on DSK3SPTVN1PROD with BILLS
14 

•S 2289 IS

1 505C on the review of the initial pediatric plan, 

2 agreed pediatric plan, and any amendments to such 

3 plans. 

4 ‘‘(7) REQUIRED RULEMAKING.—Not later than 

5 1 year after the date of enactment of the Better 

6 Pharmaceuticals and Devices for Children Act of 

7 2012, the Secretary shall promulgate proposed regu8 lations and issue proposed guidance to implement 

9 the provisions of this subsection.’’. 

10 (b) CONFORMING AMENDMENTS.—Section 505B (21 

11 U.S.C. 355c) is amended— 

12 (1) by amending subclause (II) of subsection 

13 (a)(3)(A)(ii) to read as follows: 

14 ‘‘(II) a pediatric study plan as 

15 described in subsection (e);’’; and 

16 (2) in subsection (f)— 

17 (A) in the subsection heading, by striking 

18 ‘‘PEDIATRIC PLANS,’’ and inserting ‘‘PEDI19 ATRIC STUDY PLANS,’’; 

20 (B) in paragraph (1), by striking ‘‘all pedi21 atric plans’’ and inserting ‘‘initial pediatric 

22 study plans, agreed pediatric study plans,’’; and 

23 (C) in paragraph (4)— 


tkelley on DSK3SPTVN1PROD with BILLS
15 

•S 2289 IS

1 (i) in the paragraph heading, by strik2 ing ‘‘PEDIATRIC PLANS,’’ and inserting 

3 ‘‘PEDIATRIC STUDY PLANS,’’; and 

4 (ii) by striking ‘‘pediatric plans’’ and 

5 inserting ‘‘initial pediatric study plans, 

6 agreed pediatric study plans,’’. 

7 (c) EFFECTIVE DATES.— 

8 (1) PEDIATRIC STUDY PLANS.—Subsection (e) 

9 of section 505B of the Federal Food, Drug, and 

10 Cosmetic Act (other than paragraph (4) of such sub11 section), as amended by subsection (a), shall take ef12 fect 180 days after the date of enactment of this 

13 Act, without regard to whether the Secretary has 

14 promulgated final regulations under paragraph (4) 

15 of such subsection by such date. 

16 (2) CONFORMING AMENDMENTS.—The amend17 ments made by subsection (b) shall take effect 180 

18 days after the date of enactment of this Act. 

19 SEC. 9. REAUTHORIZATIONS. 

20 (a) PEDIATRIC ADVISORY COMMITTEE.—Section 

21 14(d) of the Best Pharmaceuticals for Children Act (42 

22 U.S.C. 284m note) is amended by striking ‘‘Notwith23 standing section 14 of the Federal Advisory Committee 

24 Act, the advisory committee shall continue to operate dur25 ing the five-year period beginning on the date of the enactVerDate Mar 15 2010 21:40 Apr 18, 2012 Jkt 019200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S2289.IS S2289

tkelley on DSK3SPTVN1PROD with BILLS
16 

•S 2289 IS

1 ment of the Best Pharmaceuticals for Children Act of 

2 2007’’ and inserting ‘‘Section 14 of the Federal Advisory 

3 Committee Act shall not apply to the advisory committee’’. 

4 (b) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC

5 DRUGS ADVISORY COMMITTEE.—Section 15(a)(3) of the 

6 Best Pharmaceuticals for Children Act (42 U.S.C. 284m 

7 note) is amended by striking ‘‘ during the five-year period 

8 beginning on the date of the enactment of the Best Phar9 maceuticals for Children Act of 2007’’ and inserting ‘‘for 

10 the duration of the operation of the Oncologic Drugs Advi11 sory Committee’’. 

12 (c) HUMANITARIAN DEVICE EXEMPTION EXTEN13 SION.—Section 520(m)(6)(A)(iv) of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is 

15 amended by striking ‘‘2012’’ and inserting ‘‘2017’’. 

16 (d) DEMONSTRATION GRANTS TO IMPROVE PEDI17 ATRIC DEVICE AVAILABILITY.—Section 305(e) of Pedi18 atric Medical Device Safety and Improvement Act (Public 

19 Law 110–85; 42 U.S.C. 282 note) is amended by striking 

20 ‘‘$6,000,000 for each of fiscal years 2008 through 2012’’ 

21 and inserting ‘‘$4,500,000 for each of fiscal years 2013 

22 through 2017’’. 

23 (e) PROGRAM FOR PEDIATRIC STUDY OF DRUGS IN

24 PHSA.—Section 409I(e)(1)(B) of the Public Health Serv25 ice Act (42 U.S.C. 284m(e)(1)(B)) is amended by striking 


tkelley on DSK3SPTVN1PROD with BILLS
17 

•S 2289 IS

1 ‘‘of the four succeeding fiscal years’’ and inserting ‘‘suc2 ceeding fiscal year’’. 

3 SEC. 10. REPORT. 

4 (a) IN GENERAL.—Not later than January 1, 2016, 

5 and at the end of each subsequent 5-year period, the 

6 Comptroller General of the United States, in consultation 

7 with the Secretary of Health and Human Services, shall 

8 submit to Congress a report that evaluates the effective9 ness of sections 505A and 505B of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and sec11 tion 409I of the Public Health Service Act (42 U.S.C. 

12 284m) in ensuring that medicines used by children are 

13 tested in pediatric populations and properly labeled for use 

14 in children. 

15 (b) CONTENTS.—The report under subsection (a) 

16 shall include— 

17 (1) the number and importance of drugs and 

18 biological products for children that are being tested 

19 (as of the date of such report) under 505A and 

20 505B of the Federal Food, Drug, and Cosmetic Act 

21 (21 U.S.C. 355a, 355c) and section 409I of the 

22 Public Health Service Act (42 U.S.C. 284m), includ23 ing— 

24 (A) the number of labeling changes made 

25 to drugs and biological products pursuant to 


tkelley on DSK3SPTVN1PROD with BILLS
18 

•S 2289 IS

1 such sections since the date of enactment of 

2 this Act; and 

3 (B) the importance of such drugs and bio4 logical products in the improvement of the 

5 health of children; 

6 (2) the number of requirements under such sec7 tions 505A and 505B that have not met by the ini8 tial deadline provided under such sections, includ9 ing— 

10 (A) the number of deferrals and deferral 

11 extensions granted and the reasons such exten12 sions were granted; 

13 (B) the number of waivers and partial 

14 waivers granted; and 

15 (C) the number of letters issued under 

16 subsection (d) of such section 505B; 

17 (3) the number of written requests issued and 

18 declined under such section 505A since the date of 

19 enactment of this Act (including the reasons for 

20 such declination), and a description and status of re21 ferrals made under subsection (n) of such section 

22 505A; 

23 (4) the number and importance of drugs and 

24 biological products for children that are not being 

25 tested for use in pediatric populations, notwithVerDate Mar 15 2010 21:40 Apr 18, 2012 Jkt 019200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S2289.IS S2289

tkelley on DSK3SPTVN1PROD with BILLS
19 

•S 2289 IS

1 standing the existence of the programs under such 

2 sections 505A and 505B and section 409I of the 

3 Public Health Service Act; 

4 (5) the possible reasons for the lack of testing 

5 reported under paragraph (4); 

6 (6) the number of drugs and biological products 

7 for which testing is being done (as of the date of the 

8 report) and for which a labeling change is required 

9 under the programs described in paragraph (4), in10 cluding— 

11 (A) the date labeling changes are made; 

12 (B) which labeling changes required the 

13 use of the dispute resolution process; and 

14 (C) for labeling changes that required such 

15 dispute resolution process, a description of— 

16 (i) the disputes; 

17 (ii) the recommendations of the Pedi18 atric Advisory Committee; and 

19 (iii) the outcomes of such process; and 

20 (D) an assessment of the effectiveness in 

21 improving information about pediatric uses of 

22 drugs and biological products; 

23 (7)(A) the efforts made by the Secretary to in24 crease the number of studies conducted in the neo25 natal population (including efforts made to encourVerDate Mar 15 2010 21:40 Apr 18, 2012 Jkt 019200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S2289.IS S2289

tkelley on DSK3SPTVN1PROD with BILLS
20 

•S 2289 IS

1 age the conduct of appropriate studies in neonates 

2 by companies with products that have sufficient 

3 safety and other information to make the conduct of 

4 the studies ethical and safe); and 

5 (B) the results of such efforts; 

6 (8)(A) the number and importance of drugs and 

7 biological products for children with cancer that are 

8 being tested as a result of the programs described 

9 in paragraph (4); and 

10 (B) any recommendations for modifications to 

11 such programs that would lead to new and better 

12 therapies for children with cancer, including a de13 tailed rationale for each recommendation; 

14 (9) an assessment of progress made in address15 ing the recommendations and findings of any prior 

16 report issued by the Comptroller General regarding 

17 the topics addressed in the report under this section, 

18 including with respect to— 

19 (A) improving public access to information 

20 from pediatric studies conducted under such 

21 sections 505A and 505B; and 

22 (B) improving the timeliness of pediatric 

23 studies and pediatric study planning under such 

24 sections 505A and 505B; 


tkelley on DSK3SPTVN1PROD with BILLS
21 

•S 2289 IS

1 (10) any recommendations for modification to 

2 the programs that would improve pediatric drug re3 search and increase pediatric labeling of drugs and 

4 biological products; and 

5 (11) an assessment of the successes of and limi6 tations to studying drugs for rare diseases under 

7 such sections 505A and 505B. 

8 SEC. 11. TECHNICAL AMENDMENTS. 

9 (a) PEDIATRIC STUDIES OF DRUGS IN FFDCA.— 

10 Section 505A (21 U.S.C. 355a) is amended— 

11 (1) in subsection (k)(2), by striking ‘‘subsection 

12 (f)(3)(F)’’ and inserting ‘‘subsection (f)(6)(F)’’; 

13 (2) in subsection (n)— 

14 (A) in the subsection heading, by striking 

15 ‘‘COMPLETED’’ and inserting ‘‘SUBMITTED’’; 

16 and 

17 (B) in paragraph (1)— 

18 (i) in the matter preceding subpara19 graph (A), by striking ‘‘have not been com20 pleted’’ and inserting ‘‘have not been sub21 mitted by the date specified in the written 

22 request issued’’; 

23 (ii) in subparagraph (A)— 

24 (I) in the first sentence, by in25 serting ‘‘, or for which a period of exVerDate Mar 15 2010 21:40 Apr 18, 2012 Jkt 019200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S2289.IS S2289

tkelley on DSK3SPTVN1PROD with BILLS
22 

•S 2289 IS

1 clusivity eligible for extension under 

2 subsection (b)(1) or (c)(1) of this sec3 tion or under subsection (m)(2) or 

4 (m)(3) of section 351 of the Public 

5 Health Service Act has not ended’’ 

6 after ‘‘expired’’; and 

7 (II) by striking ‘‘Prior to’’ and 

8 all that follows through the period at 

9 the end; and 

10 (iii) in subparagraph (B), by striking 

11 ‘‘no listed patents or has 1 or more listed 

12 patents that have expired,’’ and inserting 

13 ‘‘no unexpired listed patents and for which 

14 no unexpired periods of exclusivity eligible 

15 for extension under subsection (b)(1) or 

16 (c)(1) of this section or under subsection 

17 (m)(2) or (m)(3) of section 351 of the 

18 Public Health Service Act apply’’; and 

19 (3) in subsection (o)(2), by amendment sub20 paragraph (B) to read as follows: 

21 ‘‘(B) a statement of any appropriate pedi22 atric contraindications, warnings, precautions, 

23 or other information that the Secretary con24 siders necessary to assure safe use.’’. 


tkelley on DSK3SPTVN1PROD with BILLS
23 

•S 2289 IS

1 (b) RESEARCH INTO PEDIATRIC USES FOR DRUGS

2 AND BIOLOGICAL PROJECTS IN FFDCA.—Section 505B 

3 (21 U.S.C. 355c) is amended— 

4 (1) in subsection (a)— 

5 (A) in paragraph (1)— 

6 (i) in the matter preceding subpara7 graph (A), by inserting ‘‘for a drug’’ after 

8 ‘‘(or supplement to an application)’’; 

9 (ii) in subparagraph (A), by striking 

10 ‘‘for a’’ and inserting ‘‘, including, with re11 spect to a drug, an application (or supple12 ment to an application) for a’’; 

13 (iii) in subparagraph (B), by striking 

14 ‘‘for a’’ and inserting ‘‘, including, with re15 spect to a drug, an application (or supple16 ment to an application) for a’’; and 

17 (iv) in the matter following subpara18 graph (B), by inserting ‘‘(or supplement)’’ 

19 after ‘‘application’’; and 

20 (B) in paragraph (4)(C)— 

21 (i) in the first sentence, by inserting 

22 ‘‘partial’’ before ‘‘waiver is granted’’; and 

23 (ii) in the second sentence, by insert24 ing ‘‘such a’’ after ‘‘full or’’; 


tkelley on DSK3SPTVN1PROD with BILLS
24 

•S 2289 IS

1 (2) in subsection (b)(1), in the matter pre2 ceding subparagraph (A), by striking ‘‘After pro3 viding notice’’ and all that follows through ‘‘studies), 

4 the’’ and inserting ‘‘The’’; 

5 (3) in subsection (g)— 

6 (A) in paragraph (1)(A), by inserting 

7 ‘‘that receives a priority review or 330 days 

8 after the date of the submission of an applica9 tion or supplement that receives a standard re10 view’’ after ‘‘after the date of the submission of 

11 the application or supplement’’; and 

12 (B) in paragraph (2), by striking ‘‘the 

13 label of such product’’ and inserting ‘‘the label14 ing of such product’’; and 

15 (4) in subsection (h)(1)— 

16 (A) by inserting ‘‘an application (or sup17 plement to an application) that contains’’ after 

18 ‘‘date of submission of’’; and 

19 (B) by inserting ‘‘, if the application (or 

20 supplement) receives a priority review, or not 

21 later than 330 days after the date of submis22 sion of an application (or supplement to an ap23 plication) that contains a pediatric assessment 

24 under this section, if the application (or suppleVerDate Mar 15 2010 21:40 Apr 18, 2012 Jkt 019200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\S2289.IS S2289

tkelley on DSK3SPTVN1PROD with BILLS
25 

•S 2289 IS

1 ment) receives a standard review,’’ after ‘‘under 

2 this section,’’. 

3 (c) INTERNAL REVIEW COMMITTEE.—The heading of 

4 section 505C (21 U.S.C. 355d) is amended by inserting 

5 ‘‘AND DEFERRAL EXTENSIONS’’ after ‘‘DEFERRALS’’. 

6 (d) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.— 

7 Section 409I(c) of the Public Health Service Act (42 

8 U.S.C. 284m(c)) is amended— 

9 (1) in paragraph (1)— 

10 (A) in the matter preceding subparagraph 

11 (A), by inserting ‘‘or section 351(m) of this 

12 Act,’’ after ‘‘Cosmetic Act,’’; 

13 (B) in subparagraph (A)(i), by inserting 

14 ‘‘or section 351(k) of this Act’’ after ‘‘Cosmetic 

15 Act’’; and 

16 (C) by amending subparagraph (B) to read 

17 as follows: 

18 ‘‘(B) there remains no patent listed pursu19 ant to section 505(b)(1) of the Federal Food, 

20 Drug, and Cosmetic Act, and every three-year 

21 and five-year period referred to in subsection 

22 (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), 

23 (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of 

24 section 505 of the Federal Food, Drug, and 

25 Cosmetic Act, or applicable twelve-year period 


tkelley on DSK3SPTVN1PROD with BILLS
26 

•S 2289 IS

1 referred to in section 351(k)(7) of this Act, and 

2 any seven-year period referred to in section 527 

3 of the Federal Food, Drug, and Cosmetic Act 

4 has ended for at least one form of the drug; 

5 and’’; and 

6 (2) in paragraph (2)— 

7 (A) in the paragraph heading, by striking 

8 ‘‘FOR DRUGS LACKING EXCLUSIVITY’’; 

9 (B) by striking ‘‘under section 505 of the 

10 Federal Food, Drug, and Cosmetic Act’’; and 

11 (C) by inserting ‘‘or section 351(m) of this 

12 Act,’’. 

13 (e) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC

14 ADVISORY COMMITTEE.—Section 15(a) of the Best Phar15 maceuticals for Children Act (Public Law 107–109), as 

16 amended by section 502(e) of the Food and Drug Admin17 istration Amendments Act of 2007 (Public Law 110–85), 

18 is amended in paragraph (1)(D), by striking ‘‘section 

19 505B(f)’’ and inserting ‘‘ ‘section 505C’ ’’. 

20 (f) FOUNDATION OF NATIONAL INSTITUTES OF

21 HEALTH.—Section 499(c)(1)(C) of the Public Health 

22 Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by 

23 striking ‘‘for which the Secretary issues a certification in 

24 the affirmative under section 505A(n)(1)(A) of the Fed25 eral Food, Drug, and Cosmetic Act’’. 


tkelley on DSK3SPTVN1PROD with BILLS
27 

•S 2289 IS

1 (g) APPLICATION.—Notwithstanding any provision of 

2 sections 505A and 505B of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 355a, 355c) stating that a provi4 sion applies beginning on the date of the enactment of the 

5 Best Pharmaceuticals for Children Act of 2007 or the date 

6 of the enactment of the Pediatric Research Equity Act of 

7 2007, any amendment made by this Act to such a provi8 sion applies beginning on the date of the enactment of this 

9 Act. 

Æ 


tkelley on DSK3SPTVN1PROD with BILLS