I 

110TH CONGRESS 

1ST SESSION H. R. 2589 

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 

Service Act to reauthorize and amend the Best Pharmaceuticals for 

Children Act and the Pediatric Research Equity Act. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 6, 2007 

Ms. ESHOO introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act and 

the Public Health Service Act to reauthorize and amend 

the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. 

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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Improving Pharmaceuticals for Children Act of 2007’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Reauthorization of Best Pharmaceuticals for Children Act. 

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Sec. 3. Reauthorization of Pediatric Research Equity Act. 

Sec. 4. Government Accountability Office report. 

1 SEC. 2. REAUTHORIZATION OF BEST PHARMACEUTICALS 

2 FOR CHILDREN ACT. 

3 (a) PEDIATRIC STUDIES OF DRUGS.— 

4 (1) IN GENERAL.—Section 505A of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 

6 amended to read as follows: 

7 ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS. 

8 ‘‘(a) DEFINITIONS.—As used in this section, the term 

9 ‘pediatric studies’ or ‘studies’ means at least one clinical 

10 investigation (that, at the Secretary’s discretion, may in11 clude pharmacokinetic studies) in pediatric age groups (in12 cluding neonates in appropriate cases) in which a drug 

13 is anticipated to be used, and at the discretion of the Sec14 retary, may include preclinical studies. 

15 ‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.— 

16 ‘‘(1) IN GENERAL.—Except as provided in para17 graph (2), if, prior to approval of an application that 

18 is submitted under section 505(b)(1), the Secretary 

19 determines that information relating to the use of a 

20 new drug in the pediatric population may produce 

21 health benefits in that population, the Secretary 

22 makes a written request for pediatric studies (which 

23 shall include a timeframe for completing such stud24 ies), the applicant agrees to the request, such studmstockstill on PROD1PC66 with BILLS

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1 ies are completed using appropriate formulations for 

2 each age group for which the study is requested 

3 within any such timeframe, and the reports thereof 

4 are submitted and accepted in accordance with sub5 section (d)(3), and if the Secretary determines that 

6 labeling changes are appropriate, such changes are 

7 made within the timeframe requested by the Sec8 retary— 

9 ‘‘(A)(i)(I) the period referred to in sub10 section (c)(3)(E)(ii) of section 505, and in sub11 section (j)(5)(F)(ii) of such section, is deemed 

12 to be five years and six months rather than five 

13 years, and the references in subsections 

14 (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to 

15 four years, to forty-eight months, and to seven 

16 and one-half years are deemed to be four and 

17 one-half years, fifty-four months, and eight 

18 years, respectively; or 

19 ‘‘(II) the period referred to in clauses (iii) 

20 and (iv) of subsection (c)(3)(E) of such section, 

21 and in clauses (iii) and (iv) of subsection 

22 (j)(5)(F) of such section, is deemed to be three 

23 years and six months rather than three years; 

24 and 

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1 ‘‘(ii) if the drug is designated under sec2 tion 526 for a rare disease or condition, the pe3 riod referred to in section 527(a) is deemed to 

4 be seven years and six months rather than 

5 seven years; and 

6 ‘‘(B)(i) if the drug is the subject of— 

7 ‘‘(I) a listed patent for which a certifi8 cation has been submitted under sub9 section (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of 

10 section 505 and for which pediatric studies 

11 were submitted prior to the expiration of 

12 the patent (including any patent exten13 sions); or 

14 ‘‘(II) a listed patent for which a cer15 tification has been submitted under sub16 sections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) 

17 of section 505, 

18 the period during which an application may not 

19 be approved under section 505(c)(3) or section 

20 505(j)(5)(B) shall be extended by a period of 

21 six months after the date the patent expires (in22 cluding any patent extensions); or 

23 ‘‘(ii) if the drug is the subject of a listed 

24 patent for which a certification has been sub25 mitted under subsection (b)(2)(A)(iv) or 

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1 (j)(2)(A)(vii)(IV) of section 505, and in the pat2 ent infringement litigation resulting from the 

3 certification the court determines that the pat4 ent is valid and would be infringed, the period 

5 during which an application may not be ap6 proved under section 505(c)(3) or section 

7 505(j)(5)(B) shall be extended by a period of 

8 six months after the date the patent expires (in9 cluding any patent extensions). 

10 ‘‘(2) EXCEPTION.—The Secretary shall not ex11 tend the period referred to in paragraph (1)(A) or 

12 (1)(B) if the determination is made later than one 

13 year prior to the expiration of such period. 

14 ‘‘(c) MARKET EXCLUSIVITY FOR ALREADY-MAR15 KETED DRUGS.— 

16 ‘‘(1) IN GENERAL.—Except as provided in para17 graph (2), if the Secretary determines that informa18 tion relating to the use of an approved drug in the 

19 pediatric population may produce health benefits in 

20 that population and makes a written request to the 

21 holder of an approved application under section 

22 505(b)(1) for pediatric studies (which shall include 

23 a timeframe for completing such studies), the holder 

24 agrees to the request, such studies are completed 

25 using appropriate formulations for each age group 

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1 for which the study is requested within any such 

2 timeframe and the reports thereof are submitted and 

3 accepted in accordance with subsection (d)(3), and if 

4 the Secretary determines that labeling changes are 

5 appropriate and such changes are made within the 

6 timeframe requested by the Secretary— 

7 ‘‘(A)(i)(I) the period referred to in sub8 section (c)(3)(E)(ii) of section 505, and in sub9 section (j)(5)(F)(ii) of such section, is deemed 

10 to be five years and six months rather than five 

11 years, and the references in subsections 

12 (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to 

13 four years, to forty-eight months, and to seven 

14 and one-half years are deemed to be four and 

15 one-half years, fifty-four months, and eight 

16 years, respectively; or 

17 ‘‘(II) the period referred to in clauses (iii) 

18 and (iv) of subsection (c)(3)(D) of such section, 

19 and in clauses (iii) and (iv) of subsection 

20 (j)(5)(F) of such section, is deemed to be three 

21 years and six months rather than three years; 

22 and 

23 ‘‘(ii) if the drug is designated under sec24 tion 526 for a rare disease or condition, the pe25 riod referred to in section 527(a) is deemed to 

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1 be seven years and six months rather than 

2 seven years; and 

3 ‘‘(B)(i) if the drug is the subject of— 

4 ‘‘(I) a listed patent for which a certifi5 cation has been submitted under sub6 section (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of 

7 section 505 and for which pediatric studies 

8 were submitted prior to the expiration of 

9 the patent (including any patent exten10 sions); or 

11 ‘‘(II) a listed patent for which a cer12 tification has been submitted under sub13 section (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) 

14 of section 505, 

15 the period during which an application may not 

16 be approved under section 505(c)(3) or section 

17 505(j)(5)(B)(ii) shall be extended by a period of 

18 six months after the date the patent expires (in19 cluding any patent extensions); or 

20 ‘‘(ii) if the drug is the subject of a listed 

21 patent for which a certification has been sub22 mitted under subsection (b)(2)(A)(iv) or 

23 (j)(2)(A)(vii)(IV) of section 505, and in the pat24 ent infringement litigation resulting from the 

25 certification the court determines that the patmstockstill on PROD1PC66 with BILLS

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1 ent is valid and would be infringed, the period 

2 during which an application may not be ap3 proved under section 505(c)(3) or section 

4 505(j)(5)(B) shall be extended by a period of 

5 six months after the date the patent expires (in6 cluding any patent extensions) 

7 ‘‘(2) EXCEPTION.—The Secretary shall not ex8 tend the period referred to in paragraph (1)(A) or 

9 (1)(B) if the determination is made later than one 

10 year prior to the expiration of such period. 

11 ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— 

12 ‘‘(1) REQUEST FOR STUDIES.— 

13 ‘‘(A) IN GENERAL.—The Secretary may, 

14 after consultation with the sponsor of an appli15 cation for an investigational new drug under 

16 section 505(I), the sponsor of an application for 

17 a new drug under section 505(b)(1), or the 

18 holder of an approved application for a drug 

19 under section 505(b)(1) issue to the sponsor or 

20 holder a written request for the conduct of pedi21 atric studies for such drug. In issuing such re22 quest, the Secretary shall take into account 

23 adequate representation of children of ethnic 

24 and racial minorities. Such request to conduct 

25 pediatric studies shall be in writing and shall 

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1 include a timeframe for such studies and a re2 quest to the sponsor or holder to propose pedi3 atric labeling resulting from such studies. 

4 ‘‘(B) SINGLE WRITTEN REQUEST.—A sin5 gle written request— 

6 ‘‘(i) may related to more than one use 

7 of a drug; and 

8 ‘‘(ii) may include uses that are both 

9 approved and unapproved. 

10 ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUD11 IES.— 

12 ‘‘(A) REQUEST AND RESPONSE.— 

13 ‘‘(i) IN GENERAL.—If the Secretary 

14 makes a written request for pediatric stud15 ies (including neonates, as appropriate) 

16 under subsection (b) or (c), the applicant 

17 or holder, not later than 180 days after re18 ceiving the written request, shall respond 

19 to the Secretary as to the intention of the 

20 applicant or holder to act on the request 

21 by— 

22 ‘‘(I) indicating when the pediatric 

23 studies will be initiated, if the appli24 cant or holder agrees to the request; 

25 or 

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1 ‘‘(II) indicating that the appli2 cant or holder does not agree to the 

3 request and stating the reasons for 

4 declining the request. 

5 ‘‘(ii) DISAGREE WITH REQUEST.—If, 

6 on or after the date of the enactment of 

7 the Improving Pharmaceuticals for Chil8 dren Act of 2007, the applicant or holder 

9 does not agree to the request on the 

10 grounds that it is not possible to develop 

11 the appropriate pediatric formulation, the 

12 applicant or holder shall submit to the Sec13 retary the reasons such pediatric formula14 tion cannot be developed. 

15 ‘‘(B) ADVERSE EVENT REPORTS.—An ap16 plicant or holder that, on or after the date of 

17 the enactment of the Improving Pharma18 ceuticals for Children Act of 2007, agrees to 

19 the request for such studies shall provide the 

20 Secretary, at the same time as the submission 

21 of the reports of such studies, with all 

22 postmarket adverse event reports regarding the 

23 drug that is the subject of such studies and are 

24 available prior to submission of such reports. 

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1 ‘‘(3) MEETING THE STUDIES REQUIREMENT.— 

2 Not later than 180 days after the submission of the 

3 reports of the studies, the Secretary shall accept or 

4 reject such reports and so notify the sponsor or 

5 holder. The Secretary’s only responsibility in accept6 ing or rejecting the reports shall be to determine, 

7 within the 180-day period, whether the studies fairly 

8 respond to the written request, have been conducted 

9 in accordance with commonly accepted scientific 

10 principles and protocols, and have been reported in 

11 accordance with the requirements of the Secretary 

12 for filing. 

13 ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 

14 subsection alters or amends section 301(j) of this 

15 Act or section 552 of title 5 or section 1905 of title 

16 18, United States Code. 

17 ‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES RE18 QUIREMENT.— 

19 ‘‘(1) IN GENERAL.—The Secretary shall publish 

20 a notice of any determination, made on or after the 

21 date of the enactment of the Improving Pharma22 ceuticals for Children Act of 2007, that the require23 ments of subsection (d) have been met and that sub24 missions and approvals under subsection (b)(2) or 

25 (j) of section 505 for a drug will be subject to the 

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1 provisions of this section. Such notice shall be pub2 lished not later than 30 days after the date of the 

3 Secretary’s determination regarding market exclu4 sivity and shall include a copy of the written request 

5 made under subsection (b) or (c). 

6 ‘‘(2) IDENTIFICATION OF CERTAIN DRUGS.— 

7 The Secretary shall publish a notice identifying any 

8 drug for which, on or after the date of the enact9 ment of the Improving Pharmaceuticals for Children 

10 Act of 2007, a pediatric formulation was developed, 

11 studied, and found to be safe and effective in the pe12 diatric population (or specified subpopulation) if the 

13 pediatric formulation for such drug is not introduced 

14 onto the market within one year after the date that 

15 the Secretary publishes the notice described in para16 graph (1). Such notice identifying such drug shall be 

17 published not later than 30 days after the date of 

18 the expiration of such one year period. 

19 ‘‘(f) INTERNAL REVIEW OF WRITTEN REQUESTS

20 AND PEDIATRIC STUDIES.— 

21 ‘‘(1) INTERNAL REVIEW.— 

22 ‘‘(A) IN GENERAL.—The Secretary shall 

23 establish an internal review committee to review 

24 all written requests issued on or after the date 

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1 ceuticals for Children Act of 2007, in accord2 ance with paragraph (2). 

3 ‘‘(B) MEMBERS.—The committee estab4 lished under subparagraph (A) shall include in5 dividuals with expertise in pediatrics, biophar6 macology, statistics, drugs and drug formula7 tions, legal issues, pediatric ethics, the appro8 priate expertise, such as expertise in child and 

9 adolescent psychiatry, pertaining to the pedi10 atric product under review, one or more experts 

11 from the Office of Pediatric Therapeutics, and 

12 other individuals designated by the Secretary. 

13 ‘‘(2) REVIEW OF WRITTEN REQUESTS.—The 

14 committee established under paragraph (1) shall re15 view all written requests issued pursuant to this sec16 tion prior to being issued. 

17 ‘‘(3) TRACKING PEDIATRIC STUDIES AND LA18 BELING CHANGES.—The Secretary shall track and 

19 make available to the public, in an easily accessible 

20 manner, including through posting on the website of 

21 the Food and Drug Administration— 

22 ‘‘(A) the number of studies conducted 

23 under this section and under section 409I of 

24 the Public Health Service Act (42 U.S.C. 

25 284m); 

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1 ‘‘(B) the specific drugs and biological prod2 ucts and their uses, including labeled and off3 labeled indications, studied under such sections; 

4 ‘‘(C) the types of studies conducted under 

5 such sections, including trial design, the num6 ber of pediatric patients studied, and the num7 ber of centers and countries involved; 

8 ‘‘(D) the number of pediatric formulations 

9 developed and the number of pediatric formula10 tions not developed and the reasons such for11 mulations were not developed; 

12 ‘‘(E) the labeling changes made as a result 

13 of studies conducted under such sections; 

14 ‘‘(F) an annual summary of labeling 

15 changes made as a result of studies conducted 

16 under such sections for distribution pursuant to 

17 subsection (k)(2); and 

18 ‘‘(G) information regarding reports sub19 mitted on or after the date of the enactment of 

20 the Improving Pharmaceuticals for Children 

21 Act of 2007. 

22 ‘‘(4) COMMITTEE.—The Committee established 

23 under paragraph (1) is the committee established in 

24 section 505B(f)(1).’’ 

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1 ‘‘(g) LIMITATIONS.—Notwithstanding subsection 

2 (c)(2), a drug to which the six-month period under sub3 section (b) or (c) has already been applied— 

4 ‘‘(1) may receive an additional six-month period 

5 under subsection (c)(1)(A)(i)(II) for a supplemental 

6 application if all other requirements under this sec7 tion are satisfied; and 

8 ‘‘(2) may not receive any additional such period 

9 under subsection (c)(1)(A)(ii). 

10 ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE11 QUIREMENTS.—Notwithstanding any other provision of 

12 law, if any pediatric study is required by a provision of 

13 law (including a regulation) other than this section and 

14 such study meets the completeness, timeliness, and other 

15 requirements of this section, such study shall be deemed 

16 to satisfy the requirement for market exclusivity pursuant 

17 to this section. 

18 ‘‘(i) LABELING CHANGES.— 

19 ‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLI20 CATIONS AND SUPPLEMENTS.—Any application or 

21 supplement to an application under section 505 pro22 posing a labeling change as a result of any pediatric 

23 study conducted pursuant to this section— 

24 ‘‘(A) shall be considered to be a priority 

25 application or supplement; and 

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1 ‘‘(B) shall be subject to the performance 

2 goals established by the Commissioner for pri3 ority drugs. 

4 ‘‘(2) DISPUTE RESOLUTION.— 

5 ‘‘(A) REQUEST FOR LABELING CHANGE

6 AND FAILURE TO AGREE.—If, on or after the 

7 date of the enactment of the Improving Phar8 maceuticals for Children Act of 2007, the Com9 missioner determines that the sponsor and the 

10 Commissioner have been unable to reach agree11 ment on appropriate changes to the labeling for 

12 the drug that is the subject of the application, 

13 not later than 180 days after the date of sub14 mission of the application— 

15 ‘‘(i) the Commissioner shall request 

16 that the sponsor of the application make 

17 any labeling change that the Commissioner 

18 determines to be appropriate; and 

19 ‘‘(ii) if the sponsor of the application 

20 does not agree within 30 days after the 

21 Commissioner’s request to make a labeling 

22 change requested by the Commissioner, the 

23 Commissioner shall refer the matter to the 

24 Pediatric Advisory Committee. 

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1 ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY

2 COMMITTEE.—Not later than 90 days after re3 ceiving a referral under subparagraph (A)(ii), 

4 the Pediatric Advisory Committee shall— 

5 ‘‘(i) review the pediatric study reports; 

6 and 

7 ‘‘(ii) make a recommendation to the 

8 Commissioner concerning appropriate la9 beling changes, if any. 

10 ‘‘(C) CONSIDERATION OF RECOMMENDA11 TIONS.—The Commissioner shall consider the 

12 recommendations of the Pediatric Advisory 

13 Committee and, if appropriate, not later than 

14 30 days after receiving the recommendation, 

15 make a request to the sponsor of the applica16 tion to make any labeling change that the Com17 missioner determines to be appropriate. 

18 ‘‘(D) MISBRANDING.—If the sponsor of the 

19 application, within 30 days after receiving a re20 quest under subparagraph (c), does not agree to 

21 make a labeling change requested by the Com22 missioner, the Commissioner may deem the 

23 drug that is the subject of the application to be 

24 misbranded. 

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1 ‘‘(E) NO EFFECT ON AUTHORITY.—Noth2 ing in this subsection limits the authority of the 

3 United States to bring an enforcement action 

4 under this Act when a drug lacks appropriate 

5 pediatric labeling. Neither course of action (the 

6 Pediatric Advisory Committee process or an en7 forcement action referred to in the preceding 

8 sentence) shall preclude, delay, or serve as the 

9 basis to stay the other course of action. 

10 ‘‘(j) OTHER LABELING CHANGES.—If, on or after the 

11 date of the enactment of the Improving Pharmaceuticals 

12 for Children Act of 2007, the Secretary determines that 

13 a pediatric study conducted under this section does or does 

14 not demonstrate that the drug that is the subject of the 

15 study is safe and effective in pediatric populations or sub16 populations, including whether such study results are in17 conclusive, the Secretary shall order the labeling of such 

18 product to include information about the results of the 

19 study and a statement of the Secretary’s determination. 

20 ‘‘(k) DISSEMINATION OF PEDIATRIC INFORMA21 TION.— 

22 ‘‘(1) IN GENERAL.—Not later than 180 days 

23 after the date of submission of a report on a pedi24 atric study under this section, the Secretary shall 

25 make available to the public the medical, statistical, 

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1 and clinical pharmacology reviews of pediatric stud2 ies conducted under subsection (b) or (c). 

3 ‘‘(2) DISSEMINATION OF INFORMATION RE4 GARDING LABELING CHANGES.—Beginning on the 

5 date of the enactment of the Improving Pharma6 ceuticals for Children Act of 2007, the Secretary 

7 shall require that the sponsors of the studies that re8 sult in labeling changes that are reflected in the an9 nual summary developed pursuant to subsection 

10 (f)(3)(F) distribute, at least annually (or more fre11 quently if the Secretary determines that it would be 

12 beneficial to the public health), such information to 

13 physicians and other health care providers. 

14 ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 

15 subsection alters or amends section 301(j) of this 

16 Act or section 552 of title 5 or section 1905 of title 

17 18, United States Code. 

18 ‘‘(l) ADVERSE EVENT REPORTING.— 

19 ‘‘(1) REPORTING IN YEAR ONE.—Beginning on 

20 the date of the enactment of the Improving Pharma21 ceuticals for Children Act of 2007, during the one22 year period beginning on the date a labeling change 

23 is made pursuant to subsection (I), the Secretary 

24 shall ensure that all adverse event reports that have 

25 been received for such drug (regardless of when such 

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1 report was received) are referred to the Office of Pe2 diatric Therapeutics established under section 6 of 

3 the Best Pharmaceuticals for Children Act (Public 

4 Law 107–109). In considering the reports, the Di5 rector of such Office shall provide for the review of 

6 the reports by the Pediatric Advisory Committee, in7 cluding obtaining any recommendations of such 

8 Committee regarding whether the Secretary should 

9 take action under this Act in response to such re10 ports. 

11 ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol12 lowing the one-year period described in paragraph 

13 (1), the Secretary shall, as appropriate, refer to the 

14 Office of Pediatric Therapeutics all pediatric adverse 

15 event reports for a drug for which a pediatric study 

16 was conducted under this section. In considering 

17 such reports, the Director of such Office may pro18 vide for the review of such reports by the Pediatric 

19 Advisory Committee, including obtaining any rec20 ommendation of such Committee regarding whether 

21 the Secretary should take action in response to such 

22 reports. 

23 ‘‘(3) EFFECT.—The requirements of this sub24 section shall supplement, not supplant, other review 

25 of such adverse event reports by the Secretary. 

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1 ‘‘(m) CLARIFICATION OF INTERACTION OF MARKET

2 EXCLUSIVITY UNDER THIS SECTION AND MARKET EX3 CLUSIVITY AWARDED TO AN APPLICANT FOR APPROVAL

4 OF A DRUG UNDER SECTION 505(j).—If a 180-day period 

5 under section 505(j)(5)(B)(iv) overlaps with a 6-month ex6 clusivity period under this section, so that the applicant 

7 for approval of a drug under section 505(j) entitled to the 

8 180-day period under that section loses a portion of the 

9 180-day period to which the applicant is entitled for the 

10 drug, the 180-day period shall be extended from— 

11 ‘‘(1) the date on which the 180-day period 

12 would have expired by the number of days of the 

13 overlap, if the 180-day period would, but for the ap14 plication of this subsection, expire after the 6-month 

15 exclusivity period; or 

16 ‘‘(2) the date on which the 6-month exclusivity 

17 period expires, by the number of days of the overlap 

18 if the 180-day period would, but for the application 

19 of this subsection, expire during the six-month exclu20 sivity period. 

21 ‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COM22 PLETED.— 

23 ‘‘(1) IN GENERAL.—Beginning on the date of 

24 the enactment of the Improving Pharmaceuticals for 

25 Children Act of 2007, if pediatric studies have not 

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1 been completed under subsection (d) and if the Sec2 retary, through the committee established under 

3 subsection (f), determines that there is a continuing 

4 need for information relating to the use of the drug 

5 in the pediatric population (including neonates, as 

6 appropriate), the Secretary shall— 

7 ‘‘(A) for a drug for which listed patents 

8 have not expired, make a determination regard9 ing whether an assessment shall be required to 

10 be submitted under section 505B; or 

11 ‘‘(B) for a drug that has no listed patents 

12 or has 1 or more listed patents that have ex13 pired, determine whether there are funds avail14 able under section 736 to award a grant to con15 duct the requested studies pursuant to para16 graph (2). 

17 ‘‘(2) FUNDING OF STUDIES.—If, pursuant to 

18 paragraph (1), the Secretary determines that there 

19 are funds available under section 736 to award a 

20 grant to conduct the requested pediatric studies, 

21 then the Secretary shall issue a proposal to award 

22 a grant to conduct the requested studies. If the Sec23 retary determines that funds are not available under 

24 section 736, the Secretary shall refer the drug for 

25 inclusion on the list established under section 409I 

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1 of the Public Health Services Act or the conduct of 

2 studies. 

3 ‘‘(3) PUBLIC NOTICE.—The Secretary shall give 

4 the public notice of— 

5 ‘‘(A) a decision under paragraph (1)(A) 

6 not to require an assessment under section 

7 505B and the basis for such decision; 

8 ‘‘(B) the name of any drug, its manufac9 turer, and the indications to be studied pursu10 ant to a grant made under paragraph (2); and 

11 ‘‘(C) any decision under paragraph (2) to 

12 include a drug on the list established under sec13 tion 409I of the Public Health Services Act. 

14 ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 

15 subsection alters or amends section 301(j) of this 

16 Act or section 552 of title 5 or section 1905 of Title 

17 18, United States Code 

18 ‘‘(o) PROMPT APPROVAL OF DRUGS UNDER SECTION

19 505(j) WHEN PEDIATRIC INFORMATION IS ADDED TO LA20 BELING.— 

21 ‘‘(1) GENERAL RULE.—A drug for which an ap22 plication has been submitted or approved under sec23 tion 505(j) shall not be considered ineligible for ap24 proval under that section or misbranded under sec25 tion 502 on the basis that the labeling of the drug 

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1 omits a pediatric indication or any other aspect of 

2 labeling pertaining to pediatric use when the omitted 

3 indication or other aspect is protected by patent or 

4 by exclusivity under clause (iii) or (iv) of section 

5 505(j)(5)(F). 

6 ‘‘(2) LABELING.—Notwithstanding clauses (iii) 

7 and (iv) of section 505(j)(5)(F), the Secretary may 

8 require that the labeling of a drug approved under 

9 section 505(j) that omits a pediatric indication or 

10 other aspect of labeling as described in paragraph 

11 (1) include— 

12 ‘‘(A) a statement that, because of mar13 keting exclusivity for a manufacturer— 

14 ‘‘(i) the drug is not labeled for pedi15 atric use; or 

16 ‘‘(ii) in the case of a drug for which 

17 there is an additional pediatric use not re18 ferred to in paragraph (1), the drug is not 

19 labeled for the pediatric use under para20 graph (1); and 

21 ‘‘(B) a statement of any appropriate pedi22 atric contraindications, warnings, or pre23 cautions that the Secretary considers necessary. 

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1 ‘‘(3) PRESERVATION OF PEDIATRIC EXCLU2 SIVITY AND OTHER PROVISIONS.—This subsection 

3 does not affect— 

4 ‘‘(A) the availability or scope of exclusivity 

5 under this section; 

6 ‘‘(B) the availability or scope of exclusivity 

7 under section 505 for pediatric formulations; 

8 ‘‘(C) the question of the eligibility for ap9 proval of any application under section 505(j) 

10 that omits any other conditions of approval en11 titled to exclusivity under clause (iii) or (iv) of 

12 section 505(j)(5)(F); or 

13 ‘‘(D) except as expressly provided in para14 graphs (1) and (2), the operation of section 

15 505. 

16 ‘‘(p) INSTITUTE OF MEDICINE STUDY.—Not later 

17 than 3 years after the date of the enactment of the Im18 proving Pharmaceuticals for Children Act of 2007, the 

19 Secretary shall enter into a contract with the Institute of 

20 Medicine to conduct a study and report to Congress re21 garding the written requests made and the studies con22 ducted pursuant to this section. The Institute of Medicine 

23 may devise an appropriate mechanism to review a rep24 resentative sample of requests made and studies conducted 

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1 pursuant to this section in order to conduct such study. 

2 Such study shall— 

3 ‘‘(1) review such representative written requests 

4 issued by the Secretary since 1997 under sub5 sections (b) and (c); 

6 ‘‘(2) review and assess such representative pedi7 atric studies conducted under subsections (b) and (c) 

8 since 1997 and labeling changes made as a result of 

9 such studies; 

10 ‘‘(3) review the use of extrapolation for pedi11 atric subpopulations, the use of alternative endpoints 

12 for pediatric populations, neonatal assessment tools, 

13 and ethical issues in pediatric clinical trials; and 

14 ‘‘(4) make recommendations regarding appro15 priate incentives for encouraging pediatric studies of 

16 biologics. 

17 ‘‘(q) SUNSET.—A drug may not receive any 6-month 

18 period under subsection (b) or (c) unless— 

19 ‘‘(1) on or before October 1, 2012, the Sec20 retary makes a written request for pediatric studies 

21 of the drug; 

22 ‘‘(2) on or before October 1, 2012, an applica23 tion for the drug is accepted for filing under section 

24 505(b); and 

25 ‘‘(3) all requirements of this section are met.’’. 

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1 (2) EFFECTIVE DATE.—The amendment made 

2 by this subsection shall apply to written requests 

3 under section 505A of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 355a) made after the date 

5 of the enactment of this Act. 

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

7 Section 409I of the Public Health Service Act (42 U.S.C. 

8 284m) is amended to read as follows: 

9 ‘‘SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 

10 ‘‘(a) LIST OF PRIORITY ISSUES IN PEDIATRIC

11 THERAPEUTICS.— 

12 ‘‘(1) IN GENERAL.—Not later than one year 

13 after the date of the enactment of the Improving 

14 Pharmaceuticals for Children Act of 2007, the Sec15 retary, acting through the Director of the National 

16 Institutes of Health and in consultation with the 

17 Commissioner of Food and Drugs and experts in pe18 diatric research, shall develop and publish a priority 

19 list of needs in pediatric therapeutics, including 

20 drugs or indications that require study. The list 

21 shall be revised every three years. 

22 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA23 TION.—In developing and prioritizing the list under 

24 paragraph (1), the Secretary shall consider— 

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1 ‘‘(A) therapeutic gaps in pediatrics that 

2 may include developmental pharmacology, 

3 pharmacogenetic determinants of drug re4 sponse, metabolism of drugs and biologics in 

5 children, and pediatric clinical trials; 

6 ‘‘(B) particular pediatric diseases, dis7 orders or conditions where more complete 

8 knowledge and testing of therapeutics, including 

9 drugs and biologics, may be beneficial in pedi10 atric populations; and 

11 ‘‘(C) the adequacy of necessary infrastruc12 ture to conduct pediatric pharmacological re13 search, including research networks and trained 

14 pediatric investigators. 

15 ‘‘(b) PEDIATRIC STUDIES AND RESEARCH.—The 

16 Secretary, acting through the National Institutes of 

17 Health, shall award funds to entities that have the exper18 tise to conduct pediatric clinical trials or other research 

19 (including qualified universities, hospitals, laboratories, 

20 contract research organizations, practice groups, federally 

21 funded programs such as pediatric pharmacology research 

22 units, other public or private institutions, or individuals) 

23 to enable the entities to conduct the drug studies or other 

24 research on the issues described in subsection (a). The 

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1 Secretary may use contracts, grants or other appropriate 

2 funding mechanisms to award funds under this subsection. 

3 ‘‘(c) PROCESS FOR PROPOSED PEDIATRIC STUDY

4 REQUESTS AND LABELING CHANGES.— 

5 ‘‘(1) SUBMISSION OF PROPOSED PEDIATRIC

6 STUDY REQUEST.—The Director of the National In7 stitutes of Health shall, as appropriate, submit pro8 posed pediatric study requests for consideration by 

9 the Commissioner of the Food and Drugs for pedi10 atric studies of a specific pediatric indication identi11 fied under subsection (a). Such a proposed pediatric 

12 study request shall be made in a manner equivalent 

13 to a written request made under subsection (b) or 

14 (c) of Section 505A of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 355a), including with re16 spect to the information provided on the pediatric 

17 studies to be conducted pursuant to the request. The 

18 Director of the National Institutes of Health may 

19 submit a proposed pediatric study request for a drug 

20 for which— 

21 ‘‘(A)(i) there is an approved application 

22 under section 505(j) of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 355(j)); or 

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•HR 2589 IH

1 ‘‘(ii) there is a submitted application that 

2 could be approved under the criteria of such 

3 section; and 

4 ‘‘(B) there is no patent protection or mar5 ket exclusivity protection for at least one form 

6 of the drug under the Federal Food, Drug, and 

7 Cosmetic Act; and 

8 ‘‘(C) additional studies are needed to as9 sess the safety and effectiveness of the use of 

10 the drug in the pediatric population. 

11 ‘‘(2) WRITTEN REQUEST TO HOLDERS OF AP12 PROVED APPLICATIONS FOR DRUGS LACKING EXCLU13 SIVITY.—The Commissioner of the Food and Drugs, 

14 in consultation with the Director of the National In15 stitutes of Health, may issue a written request based 

16 on the proposed pediatric study request for the indi17 cation or indications submitted pursuant to para18 graph (1) (which shall include a timeframe for nego19 tiations for an agreement) for pediatric studies con20 cerning a drug identified under subsection (a) to all 

21 holders of an approved application for the drug 

22 under section 505 of the Federal Food, Drug, and 

23 Cosmetic Act (21 U.S.C. 355). Such a written re24 quest shall be made in a manner equivalent to the 

25 manner in which a written request is made under 

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•HR 2589 IH

1 subsection (a) or (b) of section 505A of such Act 

2 (21 U.S.C. 355a), including with respect to informa3 tion provided on the pediatric studies to be con4 ducted pursuant to the request and using appro5 priate formulations for each age group for which the 

6 study is requested. 

7 ‘‘(3) REQUESTS FOR PROPOSALS.—If the Com8 missioner of the Food and Drugs does not receive a 

9 response to a written request issued under para10 graph (2) not later than 30 days after the date on 

11 which a request was issued, the Secretary, acting 

12 through the Director of the National Institutes of 

13 Health and in consultation with the Commissioner of 

14 the Food and Drugs, shall publish a request for pro15 posals to conduct the pediatric studies described in 

16 the written request in accordance with subsection 

17 (b). 

18 ‘‘(4) DISQUALIFICATION.—A holder that re19 ceives a first right of refusal shall not be entitled to 

20 respond to a request for proposals under paragraph 

21 (3). 

22 ‘‘(5) CONTRACTS, GRANTS, OR OTHER FUNDING

23 MECHANISMS.—A contract, grant or other funding 

24 may be awarded under this section only if a proposal 

25 is submitted to the Secretary in such form and manmstockstill on PROD1PC66 with BILLS

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1 ner, and containing such agreements, assurances, 

2 and information as the Secretary determines to be 

3 necessary to carry out this section. 

4 ‘‘(6) REPORTING OF STUDIES.— 

5 ‘‘(A) IN GENERAL.—On completion of a 

6 pediatric study in accordance with an award 

7 under this section, a report concerning the 

8 study shall be submitted to the Director of the 

9 National Institutes of Health and the Commis10 sioner of Food and Drugs. The report shall in11 clude all data generated in connection with the 

12 study, including a written request if issued. 

13 ‘‘(B) AVAILABILITY OF REPORTS.—Each 

14 report submitted under subparagraph (A) shall 

15 be considered to be in the public domain (sub16 ject to section 505A(d)(4)(D) of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 

18 355a(d)(4)(D)) and shall be assigned a docket 

19 number by the Commissioner of Food and 

20 Drugs. An interested person may submit writ21 ten comments concerning such pediatric studies 

22 to the Commissioner of Food and Drugs, and 

23 the written comments shall become part of the 

24 docket file with respect to each of the drugs. 

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1 ‘‘(C) ACTION BY COMMISSIONER.—The 

2 Commissioner of Food and Drugs shall take ap3 propriate action in response to the reports sub4 mitted under subparagraph (A) in accordance 

5 with paragraph (7). 

6 ‘‘(7) REQUESTS FOR LABELING CHANGE.—Dur7 ing the 180-day period after the date on which a re8 port is submitted under paragraph (6)(A), the Com9 missioner of Food and Drugs shall— 

10 ‘‘(A) review the report and such other data 

11 as are available concerning the safe and effec12 tive use in the pediatric population of the drug 

13 studied; 

14 ‘‘(B) negotiate with the holders of ap15 proved applications for the drug studied for any 

16 labeling changes that the Commissioner of Food 

17 and Drugs determines to be appropriate and re18 quests the holders to make; and 

19 ‘‘(C)(i) place in the public docket file a 

20 copy of the report and of any requested labeling 

21 changes; and 

22 ‘‘(ii) publish in the Federal Register and 

23 through a posting on the website of the Food 

24 and Drug Administration a summary of the remstockstill on PROD1PC66 with BILLS

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1 port and a copy of any requested labeling 

2 changes. 

3 ‘‘(8) DISPUTE RESOLUTION.— 

4 ‘‘(A) REFERRAL TO PEDIATRIC ADVISORY

5 COMMITTEE.—If, not later than the end of the 

6 180-day period specified in paragraph (7), the 

7 holder of an approved application for the drug 

8 involved does not agree to any labeling change 

9 requested by the Commissioner of Food and 

10 Drugs under that paragraph, the Commissioner 

11 of Food and Drugs shall refer the request to 

12 the Pediatric Advisory Committee. 

13 ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY

14 COMMITTEE.—Not later than 90 days after re15 ceiving a referral under subparagraph (A), the 

16 Pediatric Advisory Committee shall— 

17 ‘‘(i) review the available information 

18 on the safe and effective use of the drug 

19 in the pediatric population, including study 

20 reports submitted under this section; and 

21 ‘‘(ii) make a recommendation to the 

22 Commissioner of Food and Drugs as to ap23 propriate labeling changes, if any. 

24 ‘‘(9) FDA DETERMINATION.—Not later than 30 

25 days after receiving a recommendation from the Pemstockstill on PROD1PC66 with BILLS

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1 diatric Advisory Committee under paragraph 

2 (8)(B)(ii) with respect to a drug, the Commissioner 

3 of Food and Drugs shall consider the recommenda4 tion and, if appropriate, make a request to the hold5 ers of approved applications for the drug to make 

6 any labeling change that the Commissioner of Food 

7 and Drugs determines to be appropriate. 

8 ‘‘(10) FAILURE TO AGREE.—If a holder of an 

9 approved application for a drug, within 30 days 

10 after receiving a request to make a labeling change 

11 under paragraph (9), does not agree to make a re12 quested labeling change, the Commissioner of Food 

13 and Drugs may deem the drug to be misbranded 

14 under the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 301 et seq.). 

16 ‘‘(11) NO EFFECT ON AUTHORITY.—Nothing in 

17 this subsection limits the authority of the United 

18 States to bring an enforcement action under the 

19 Federal Food, Drug, and Cosmetic Act when a drug 

20 lacks appropriate pediatric labeling. Neither course 

21 of action (the Pediatric Advisory Committee process 

22 or an enforcement action referred to in the pre23 ceding sentence) shall preclude, delay, or serve as 

24 the basis to stay the other course of action. 

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1 ‘‘(d) DISSEMINATION OF PEDIATRIC INFORMA2 TION.—Not later than one year after the date of the enact3 ment of the Improving Pharmaceuticals for Children Act 

4 of 2007, the Secretary, acting through the Director of the 

5 National Institutes of Health, shall study the feasibility 

6 of establishing a compilation of information on pediatric 

7 drug use and report the findings to Congress. 

8 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 

9 ‘‘(1) IN GENERAL.—There are authorized to be 

10 appropriated to carry out this section— 

11 ‘‘(A) $200,000,000 for fiscal year 2008; 

12 and 

13 ‘‘(B) such sums as are necessary for each 

14 of the four succeeding fiscal years. 

15 ‘‘(2) AVAILABILITY.—Any amount appropriated 

16 under paragraph (1) shall remain available to carry 

17 out this section until expended.’’. 

18 (c) FEES RELATING TO DRUGS.—Section 735(6) of 

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

20 379(6)) is amended by adding at the end the following 

21 new subparagraph: 

22 ‘‘(G) Activities relating to the support of 

23 studies of drugs on pediatric populations under 

24 section 505A(n)(1).’’. 

25 (d) TRAINING OF PEDIATRIC PHARMACOLOGISTS.— 

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1 (1) INVESTMENT IN TOMORROW’S PEDIATRIC

2 RESEARCHERS.—Section 452G(2) of the Public 

3 Health Service Act (42 U.S.C. 285g–10(2)) is 

4 amended by inserting before the period at the end 

5 the following: ‘‘, including pediatric pharmacological 

6 research’’. 

7 (2) PEDIATRIC RESEARCH LOAN REPAYMENT

8 PROGRAM.—Section 487F(a)(1) of the Public Health 

9 Service Act (42 U.S.C. 288–6(a)(1)) is amended by 

10 inserting ‘‘including pediatric pharmacological re11 search,’’ after ‘‘pediatric research,’’. 

12 (e) FOUNDATION FOR THE NATIONAL INSTITUTES

13 OF HEALTH.—Section 499(c)(1)(c) of the Public Health 

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

15 striking ‘‘and studies listed by the Secretary pursuant to 

16 section 409I(a)(1)(A) of this Act and referred under sec17 tion 505A(d)(4)(c) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 355(a)(d)(4)(c))’’. 

19 (f) CONTINUATION OF OPERATION OF COM20 MITTEE.—Section 14 of the Best Pharmaceuticals for 

21 Children Act (42 U.S.C. 284m note) is amended by adding 

22 at the end the following new subsection: 

23 ‘‘(d) CONTINUATION OF OPERATION OF COM24 MITTEE.—Notwithstanding section 14 of the Federal Ad25 visory Committee Act (5 U.S.C. App.), the advisory commstockstill on PROD1PC66 with BILLS

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•HR 2589 IH

1 mittee shall continue to operate during the five-year period 

2 beginning on the date of the enactment of the Improving 

3 Pharmaceuticals for Children Act of 2007.’’. 

4 (g) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC

5 DRUGS ADVISORY COMMITTEE.—Section 15 of the Best 

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

7 is amended— 

8 (1) in subsection (a)— 

9 (A) in paragraph (1)— 

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

11 ‘‘and’’ after the semicolon; 

12 (ii) in subparagraph (c), by striking 

13 the period at the end and inserting ‘‘; 

14 and’’; and 

15 (iii) by adding at the end the fol16 lowing new subparagraph: 

17 ‘‘(D) provide recommendations to the in18 ternal review committee created under section 

19 505A(f) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 355a(f)) regarding the 

21 implementation of amendments to sections 

22 505A and 505B of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 355a and 355c) 

24 with respect to the treatment of pediatric can25 cers.’’; and 

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•HR 2589 IH

1 (B) by adding at the end the following new 

2 paragraph: 

3 ‘‘(3) CONTINUATION OF OPERATION OF SUB4 COMMITTEE.—Notwithstanding section 14 of the 

5 Federal Advisory Committee Act (5 U.S.C. App.), 

6 the Subcommittee shall continue to operate during 

7 the five-year period beginning on the date of the en8 actment of the Improving Pharmaceuticals for Chil9 dren Act of 2007.’’; and 

10 (2) in subsection (d), by striking ‘‘2003’’ and 

11 inserting ‘‘2009’’. 

12 (h) EFFECTIVE DATE AND LIMITATION FOR RULE

13 RELATING TO TOLL-FREE NUMBER FOR ADVERSE

14 EVENTS ON LABELING FOR HUMAN DRUG PRODUCTS.— 

15 (1) IN GENERAL.—Notwithstanding subchapter 

16 II of chapter 5, and chapter 7, of title 5, United 

17 States Code (commonly known as the ‘‘Administra18 tive Procedure Act’’) and any other provision of law, 

19 the proposed rule issued by the Commissioner of 

20 Food and Drugs entitled ‘‘Toll-Free Number for Re21 porting Adverse Events on Labeling for Human 

22 Drug Products,’’ 69 Fed. Reg. 21778, (April 22, 

23 2004) shall take effect on January 1, 2008, unless 

24 such Commissioner issues the final rule before such 

25 date. 

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1 (2) LIMITATION.—The proposed rule that takes 

2 effect under subsection (a), or the final rule de3 scribed under subsection (a), shall, notwithstanding 

4 section 17(a) of the Best Pharmaceuticals for Chil5 dren Act (21 U.S.C. 355b(a)), not apply to a drug— 

6 (A) for which an application is approved 

7 under section 505 of the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 355); 

9 (B) that is not described under section 

10 503(b)(1) of such Act (21 U.S.C. 353(b)(1)); 

11 and 

12 (C) the packaging of which includes a toll13 free number through which consumers can re14 port complaints to the manufacturer or dis15 tributor of the drug. 

16 SEC. 3. REAUTHORIZATION OF PEDIATRIC RESEARCH EQ17 UITY ACT. 

18 Section 505B of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 355c) is amended to read as follows: 

20 ‘‘SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS 

21 AND BIOLOGICAL PRODUCTS. 

22 ‘‘(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.— 

23 ‘‘(1) IN GENERAL.—A person that submits an 

24 application (or supplement to an application)— 

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1 ‘‘(A) under section 505 for a new active in2 gredient, new indication, new dosage form, new 

3 dosing regimen, or new route of administration; 

4 or 

5 ‘‘(B) under section 351 of the Public 

6 Health Service Act (42 U.S.C. 262) for a new 

7 active ingredient, new indication, new dosage 

8 form, new dosing regimen, or new route of ad9 ministration; shall submit with the application 

10 the assessments described in paragraph (2). 

11 ‘‘(2) ASSESSMENTS.— 

12 ‘‘(A) IN GENERAL.—The assessments re13 ferred to in paragraph (1) shall contain data, 

14 gathered using appropriate formulations for 

15 each age group for which the assessment is re16 quired, that are adequate— 

17 ‘‘(i) to assess the safety and effective18 ness of the drug or the biological product 

19 for the claimed indications in all relevant 

20 pediatric subpopulations; and 

21 ‘‘(ii) to support dosing and adminis22 tration for each pediatric subpopulation for 

23 which the drug or the biological product is 

24 safe and effective. 

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1 ‘‘(B) SIMILAR COURSE OF DISEASE OR

2 SIMILAR EFFECT OF DRUG OR BIOLOGICAL

3 PRODUCT.— 

4 ‘‘(i) IN GENERAL.—If the course of 

5 the disease and the effects of the drug are 

6 sufficiently similar in adults and pediatric 

7 patients, the Secretary may conclude that 

8 pediatric effectiveness can be extrapolated 

9 from adequate and well-controlled studies 

10 in adults, usually supplemented with other 

11 information obtained in pediatric patients, 

12 such as pharmacokinetic studies. 

13 ‘‘(ii) EXTRAPOLATION BETWEEN AGE

14 GROUPS.—A study may not be needed in 

15 each pediatric age group if data from one 

16 age group can be extrapolated to another 

17 age group. 

18 ‘‘(iii) INFORMATION ON EXTRAPO19 LATION.—A brief documentation of the sci20 entific data supporting the conclusion 

21 under clauses (i) and (ii) shall be included 

22 in the medical review that is collected as 

23 part of the application under section 505 

24 of this Act or section 351 of the Public 

25 Health Service Act (42 U.S.C. 262). 

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1 ‘‘(3) DEFERRAL.— 

2 ‘‘(A) IN GENERAL.—On the initiative of 

3 the Secretary or at the request of the applicant, 

4 the Secretary may defer submission of some or 

5 all assessments required under paragraph (1) 

6 until a specified date after approval of the drug 

7 or issuance of the license for a biological prod8 uct if— 

9 ‘‘(i) the Secretary finds that— 

10 ‘‘(I) the drug or biological prod11 uct is ready for approval for use in 

12 adults before pediatric studies are 

13 complete; 

14 ‘‘(II) pediatric studies should be 

15 delayed until additional safety or ef16 fectiveness data have been collected; 

17 or 

18 ‘‘(III) there is another appro19 priate reason for deferral; and 

20 ‘‘(ii) the applicant submits to the Sec21 retary— 

22 ‘‘(I) certification of the grounds 

23 for deferring the assessments; 

24 ‘‘(II) a description of the planned 

25 or ongoing studies; 

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•HR 2589 IH

1 ‘‘(III) evidence that the studies 

2 are being conducted or will be con3 ducted with due diligence and at the 

4 earliest possible time; and 

5 ‘‘(IV) a timeline for the comple6 tion of such studies. 

7 ‘‘(B) ANNUAL REVIEW.— 

8 ‘‘(i) IN GENERAL.—On an annual 

9 basis following the approval of a deferral 

10 under subparagraph (A), the applicant 

11 shall submit to the Secretary the following 

12 information: 

13 ‘‘(I) Information detailing the 

14 progress made in conducting pediatric 

15 studies. 

16 ‘‘(II) If no progress has been 

17 made in conducting such studies, evi18 dence and documentation that such 

19 studies will be conducted with due 

20 diligence and at the earliest possible 

21 time. 

22 ‘‘(ii) PUBLIC AVAILABILITY.—The in23 formation submitted through the annual 

24 review under clause (I) shall promptly be 

25 made available to the public in an easily 

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•HR 2589 IH

1 accessible manner, including through the 

2 website of the Food and Drug Administra3 tion. 

4 ‘‘(4) WAIVERS.— 

5 ‘‘(A) FULL WAIVER.—On the initiative of 

6 the Secretary or at the request of an applicant, 

7 the Secretary shall grant a full waiver, as ap8 propriate, of the requirement to submit assess9 ments for a drug or biological product under 

10 this subsection if the applicant certifies and the 

11 Secretary finds that— 

12 ‘‘(i) necessary studies are impossible 

13 or highly impracticable (because, for exam14 ple, the number of patients is so small or 

15 the patients are geographically dispersed); 

16 ‘‘(ii) there is evidence strongly sug17 gesting that the drug or biological product 

18 would be ineffective or unsafe in all pedi19 atric age groups; or 

20 ‘‘(iii) The drug or biological product— 

21 ‘‘(I) does not represent a mean22 ingful therapeutic benefit over existing 

23 therapies for pediatric patients; and 

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1 ‘‘(II) is not likely to be used in a 

2 substantial number of pediatric pa3 tients. 

4 ‘‘(B) PARTIAL WAIVER.—On the initiative 

5 of the Secretary or at the request of an appli6 cant, the Secretary shall grant a partial waiver, 

7 as appropriate, of the requirement to submit as8 sessments for a drug or biological product 

9 under this subsection with respect to a specific 

10 pediatric age group if the applicant certifies 

11 and the secretary finds that— 

12 ‘‘(i) necessary studies are impossible 

13 or highly impracticable (because, for exam14 ple, the number of patients in that age 

15 group is so small or patients in that age 

16 group are geographically dispersed); 

17 ‘‘(ii) there is evidence strongly sug18 gesting that the drug or biological product 

19 would be ineffective or unsafe in that age 

20 group; 

21 ‘‘(iii) the drug or biological product— 

22 ‘‘(I) does not represent a mean23 ingful therapeutic benefit over existing 

24 therapies for pediatric patients in that 

25 age group; and 

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•HR 2589 IH

1 ‘‘(II) is not likely to be used by 

2 a substantial number of pediatric pa3 tients in that age group; or 

4 ‘‘(iv) the applicant can demonstrate 

5 that reasonable attempts to produce a pe6 diatric formulation necessary for that age 

7 group have failed. 

8 ‘‘(C) PEDIATRIC FORMULATION NOT POS9 SIBLE.—If a waiver is granted on the ground 

10 that it is not possible to develop a pediatric for11 mulation, the waiver shall cover only the pedi12 atric groups requiring that formulation. An ap13 plicant seeking either a full or partial waiver 

14 shall submit to the Secretary documentation de15 tailing why a pediatric formulation cannot be 

16 developed and, if the waiver is granted, the ap17 plicant’s submission shall promptly be made 

18 available to the public in an easily accessible 

19 manner, including through posting on the 

20 website of the Food and Drug Administration. 

21 ‘‘(D) LABELING REQUIREMENT.—If the 

22 Secretary grants a full or partial waiver because 

23 there is evidence that a drug or biological prod24 uct would be ineffective or unsafe in pediatric 

25 populations, the information shall be included 

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•HR 2589 IH

1 in the labeling for the drug or biological prod2 uct. 

3 ‘‘(b) MARKETED DRUGS AND BIOLOGICAL PROD4 UCTS.— 

5 ‘‘(1) IN GENERAL.—After providing notice in 

6 the form of a letter and an opportunity for written 

7 response and a meeting, which may include an advi8 sory committee meeting, the Secretary may (by 

9 order in the form of a letter) require the sponsor or 

10 holder of an approved application for a drug under 

11 section 505 or the holder of a license for a biological 

12 product under section 351 of the Public Health 

13 Service Act (42 U.S.C. 262) to submit by a specified 

14 date the assessments described in subsection (a)(2) 

15 and the written request, as appropriate, if the Sec16 retary finds that— 

17 ‘‘(A)(i) the drug or biological product is 

18 used for a substantial number of pediatric pa19 tients for the labeled indications; and 

20 ‘‘(ii) adequate pediatric labeling could con21 fer a benefit on pediatric patients; 

22 ‘‘(B) there is reason to believe that the 

23 drug or biological product would represent a 

24 meaningful therapeutic benefit over existing 

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•HR 2589 IH

1 therapies for pediatric patients for 1 or more of 

2 the claimed indications; or 

3 ‘‘(C) the absence of adequate pediatric la4 beling could pose a risk to pediatric patients. 

5 ‘‘(2) WAIVERS.— 

6 ‘‘(A) FULL WAIVER.—At the request of an 

7 applicant, the Secretary shall grant a full waiv8 er, as appropriate, of the requirement to submit 

9 assessments under this subsection if the appli10 cant certifies and the Secretary finds that— 

11 ‘‘(i) necessary studies are impossible 

12 or highly impracticable (because, for exam13 ple, the number of patients in that age 

14 group is so small or patients in that age 

15 group are geographically dispersed); or 

16 ‘‘(ii) there is evidence strongly sug17 gesting that the drug or biological product 

18 would be ineffective or unsafe in all pedi19 atric age groups. 

20 ‘‘(B) PARTIAL WAIVER.—At the request of 

21 an applicant, the Secretary shall grant a partial 

22 waiver, as appropriate, of the requirement to 

23 submit assessments under this subsection with 

24 respect to a specific pediatric age group if the 

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1 applicant certifies and the Secretary finds 

2 that— 

3 ‘‘(i) necessary studies are impossible 

4 or highly impracticable (because, for exam5 ple, the number of patients in that age 

6 group is so small or patients in that age 

7 group are geographically dispersed); 

8 ‘‘(ii) there is evidence strongly sug9 gesting that the drug or biological product 

10 would be ineffective or unsafe in that age 

11 group; 

12 ‘‘(iii)(I) the drug or biological prod13 uct— 

14 ‘‘(aa) does not represent a mean15 ingful therapeutic benefit over existing 

16 therapies for pediatric patients in that 

17 age group; and 

18 ‘‘(bb) is not likely to be used in 

19 a substantial number of pediatric pa20 tients in that age group; and 

21 ‘‘(II) the absence of adequate labeling 

22 could not pose significant risks to pediatric 

23 patients; or 

24 ‘‘(iv) the applicant can demonstrate 

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1 diatric formulation necessary for that age 

2 group have failed. 

3 ‘‘(C) PEDIATRIC FORMULATION NOT POS4 SIBLE.—If a waiver is granted on the ground 

5 that it is not possible to develop a pediatric for6 mulation, the waiver shall cover only the pedi7 atric groups requiring that formulation. An ap8 plicant seeking either a full or partial waiver 

9 shall submit to the Secretary documentation de10 tailing why a pediatric formulation cannot be 

11 developed and, if the waiver is granted, the ap12 plicant’s submission shall promptly be made 

13 available to the public in an easily accessible 

14 manner, including through posting on the 

15 website of the Food and Drug Administration. 

16 ‘‘(D) LABELING REQUIREMENT.—If the 

17 Secretary grants a full or partial waiver because 

18 there is evidence that a drug or biological prod19 uct would be ineffective or unsafe in pediatric 

20 populations, the information shall be included 

21 in the labeling for the drug or biological prod22 uct. 

23 ‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For 

24 the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) 

25 of subsection (a) and paragraphs (1)(B)(I) and 

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1 (2)(B)(iii)(I)(aa) of subsection (b), a drug or biological 

2 product shall be considered to represent a meaningful 

3 therapeutic benefit over existing therapies if the Secretary 

4 determines that— 

5 ‘‘(1) if approved, the drug or biological product 

6 could represent an improvement in the treatment, 

7 diagnosis, or prevention of a disease, compared with 

8 marketed products adequately labeled for that use in 

9 the relevant pediatric population; or 

10 ‘‘(2) the drug or biological product is in a class 

11 of products or for an indication for which there is 

12 a need for additional options. 

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

14 fails to submit an assessment described in subsection 

15 (a)(2), or a request for approval of a pediatric formulation 

16 described in subsection (a) or (b), in accordance with ap17 plicable provisions of subsections (a) and (b)— 

18 ‘‘(1) the drug or biological product that is the 

19 subject of the assessment or request may be consid20 ered misbranded solely because of that failure and 

21 subject to relevant enforcement action (except that 

22 the drug or biological product shall not be subject to 

23 action under section 303); but 

24 ‘‘(2) the failure to submit the assessment or re25 quest shall not be the basis for a proceeding— 

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

2 under section 505(e); or 

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

4 product under section 351 of the Public Health 

5 Service Act (42 U.S.C. 262). 

6 ‘‘(e) MEETINGS.—Before and during the investiga7 tional process for a new drug or biological product, the 

8 Secretary shall meet at appropriate times with the sponsor 

9 of the new drug or biological product to discuss— 

10 ‘‘(1) information that the sponsor submits on 

11 plans and timelines for pediatric studies; or 

12 ‘‘(2) any planned request by the sponsor for 

13 waiver or deferral of pediatric studies. 

14 ‘‘(f) REVIEW OF PEDIATRIC ASSESSMENTS, DEFER15 RALS, AND WAIVERS.— 

16 ‘‘(1) REVIEW.—The Secretary shall create an 

17 internal committee to review all pediatric assess18 ments issued under this section and all deferral and 

19 waiver requests made pursuant to this section. Such 

20 internal committee shall include individuals, each of 

21 whom is an employee of the Food and Drug Admin22 istration, with expertise in pediatrics, biopharma23 cology, statistics, drugs and drug formulations, legal 

24 issues, pediatric ethics, the appropriate expertise, 

25 such as expertise in child and adolescent psychiatry, 

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1 pertaining to the pediatric product under review, one 

2 or more experts from the Office of Pediatric Thera3 peutics, and other individuals designated by the Sec4 retary. 

5 ‘‘(2) ACTION BY COMMITTEE.—The committee 

6 established under paragraph (1) may perform a 

7 function under this section using appropriate mem8 bers of the committee described in paragraph (1) 

9 and need not convene all members of the committee 

10 described in paragraph (1) in order to perform a 

11 function under this section. 

12 ‘‘(3) DOCUMENTATION OF COMMITTEE AC13 TION.—For each drug or biological product, the 

14 committee established under this paragraph shall 

15 document for each function described in paragraph 

16 (4) which members of the committee participated in 

17 such function. 

18 ‘‘(4) REVIEW OF REQUESTS FOR PEDIATRIC AS19 SESSMENTS, DEFERRALS AND WAIVERS.—All re20 quests for a pediatric assessment issued pursuant to 

21 this section and all requests for deferrals and waiv22 ers from the requirement to conduct a pediatric as23 sessment under this section shall be reviewed by the 

24 committee established under paragraph (1). 

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1 ‘‘(5) TRACKING OF ASSESSMENTS AND LABEL2 ING CHANGES.—The Secretary shall track and make 

3 available to the public in an easily accessible man4 ner, including through post on the website of the 

5 Food and Drug Administration— 

6 ‘‘(A) the number of assessments conducted 

7 under this section; 

8 ‘‘(B) the specific drugs and biological prod9 ucts and their uses assessed under this section; 

10 ‘‘(C) the types of assessments conducted 

11 under this section, including trial design, the 

12 number of pediatric patients studied, and the 

13 number of centers and countries involved; 

14 ‘‘(D) the total number of deferrals re15 quested and granted under this section and, if 

16 granted, the reasons for such deferrals, the 

17 timeline for completion, and the number com18 pleted and pending by the specified date, as 

19 outlined in subsection (a)(3); 

20 ‘‘(E) the number of waivers requested and 

21 granted under this section and, if granted, the 

22 reasons for the waivers; 

23 ‘‘(F) the number of pediatric formulations 

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1 tions not developed and the reasons any such 

2 formulation were not developed; 

3 ‘‘(G) the labeling changes made as a result 

4 of assessments conducted under this section; 

5 ‘‘(H) an annual summary of labeling 

6 changes made as a result of assessments con7 ducted under this section for distribution pursu8 ant to subsection (h)(2); and 

9 ‘‘(I) an annual summary of information 

10 submitted pursuant to subsection (a)(3)(B). 

11 ‘‘(6) COMMITTEE.—The committee established 

12 under paragraph (1) is the committee established 

13 under section 505A(f)(1). 

14 ‘‘(g) LABELING CHANGES.— 

15 ‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLI16 CATIONS.—Any supplement to an application under 

17 section 505 and section 351 of the Public Health 

18 Service Act proposing a labeling change as a result 

19 of any pediatric assessments conducted pursuant to 

20 this section— 

21 ‘‘(A) shall be considered a priority applica22 tion or supplement; and 

23 ‘‘(B) shall be subject to the performance 

24 goals established by the Commissioner for pri25 ority drugs. 

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1 ‘‘(2) DISPUTE RESOLUTION.— 

2 ‘‘(A) REQUEST FOR LABELING CHANGE

3 AND FAILURE TO AGREE.—If the Commissioner 

4 determines that a sponsor and the Commis5 sioner have been unable to reach agreement on 

6 appropriate changes to the labeling for the drug 

7 that is the subject of the application or supple8 ment, not later than 180 days after the date of 

9 the submission of the application or supple10 ment— 

11 ‘‘(i) the Commissioner shall request 

12 that the sponsor of the application make 

13 any labeling change that the Commissioner 

14 determines to be appropriate; and 

15 ‘‘(ii) if the sponsor does not agree 

16 within 30 days after the Commissioner’s 

17 request to make a labeling change re18 quested by the Commissioner, the Commis19 sioner shall refer the matter to the Pedi20 atric Advisory Committee. 

21 ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY

22 COMMITTEE.—Not later than 90 days after re23 ceiving a referral under subparagraph (A)(ii), 

24 the Pediatric Advisory Committee shall— 

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1 ‘‘(i) review the pediatric study reports; 

2 and 

3 ‘‘(ii) make a recommendation to the 

4 Commissioner concerning appropriate la5 beling changes, if any. 

6 ‘‘(C) CONSIDERATION OF RECOMMENDA7 TIONS.—The Commissioner shall consider the 

8 recommendations of the Pediatric Advisory 

9 Committee and, if appropriate, not later than 

10 30 days after receiving the recommendation, 

11 make a request to the sponsor of the applica12 tion to make any labeling changes that the 

13 Commissioner determines to be appropriate. 

14 ‘‘(D) MISBRANDING.—If the sponsor of the 

15 application, within 30 days after receiving a re16 quest under subparagraph (c), does not agree to 

17 make a labeling change requested by the Com18 missioner, the Commissioner may deem the 

19 drug that is the subject of the application to be 

20 misbranded. 

21 ‘‘(E) NO EFFECT ON AUTHORITY.—Noth22 ing in this subsection limits the authority of the 

23 United States to bring an enforcement action 

24 under this Act when a drug lacks appropriate 

25 pediatric labeling. Neither course of action (the 

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1 Pediatric Advisory Committee process or an en2 forcement action referred to in the preceding 

3 sentence) shall preclude, delay, or serve as the 

4 basis to stay the other course of action. 

5 ‘‘(3) OTHER LABELING CHANGES.—If the Sec6 retary makes a determination that a pediatric as7 sessment conducted under this section does or does 

8 not demonstrate that the drug that is the subject of 

9 such assessment is safe and effective in pediatric 

10 populations or subpopulations, including whether 

11 such assessment results are inconclusive, the Sec12 retary shall order the label of such product to in13 clude information about the results of the assess14 ment and a statement of the Secretary’s determina15 tion. 

16 ‘‘(h) DISSEMINATION OF PEDIATRIC INFORMA17 TION.— 

18 ‘‘(1) IN GENERAL.—Not later than 180 days 

19 after the date of submission of a pediatric assess20 ment under this section, the Secretary shall make 

21 available to the public in an easily accessible manner 

22 the medical, statistical, and clinical pharmacology re23 views of such pediatric assessments, and shall post 

24 such assessments on the website of the Food and 

25 Drug Administration. 

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1 ‘‘(2) DISSEMINATION OF INFORMATION RE2 GARDING LABELING CHANGES.—The Secretary shall 

3 require that the sponsors of the assessments that re4 sult in labeling changes that are reflected in the an5 nual summary developed pursuant to subsection 

6 (f)(5)(H) distribute such information to physicians 

7 and other health care providers. 

8 ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 

9 subsection shall alter or amend Section 301(j) of 

10 this Act or section 552 of title 5 or section 1905 of 

11 title 18, United States Code. 

12 ‘‘(i) ADVERSE EVENT REPORTING.— 

13 ‘‘(1) REPORTING IN YEAR ONE.—During the 

14 one-year period beginning on the date a labeling 

15 change is made pursuant to subsection (g), the Sec16 retary shall ensure that all adverse event reports 

17 that have been received for such drug (regardless of 

18 when such report was received) are referred to the 

19 Office of Pediatric Therapeutics. In considering the 

20 report, the Director of such Office shall provide for 

21 the review of the report by the Pediatric Advisory 

22 Committee, including obtaining any recommenda23 tions of such committee regarding whether the Sec24 retary should take action under this Act in response 

25 to such report. 

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1 ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol2 lowing the one-year period described in paragraph 

3 (1), the Secretary shall, as appropriate, refer to the 

4 Office of Pediatric Therapeutics all pediatric adverse 

5 event reports for a drug for which a pediatric study 

6 was conducted under this section. In considering the 

7 report, the Director of such Office may provide for 

8 the review of the report by the Pediatric Advisory 

9 Committee, including obtaining any recommendation 

10 of such Committee regarding whether the Secretary 

11 should take action in response to such report. 

12 ‘‘(3) EFFECT.—The requirements of this sub13 section shall supplement, not supplant, other review 

14 of such adverse event reports by the Secretary. 

15 ‘‘(j) SCOPE OF AUTHORITY.—Nothing in this section 

16 provides to the Secretary any authority to require a pedi17 atric assessment of any drug or biological product, or any 

18 assessment regarding other populations or uses of a drug 

19 or biological product, other than the pediatric assessments 

20 described in this section. 

21 ‘‘(k) ORPHAN DRUGS.—Unless the Secretary re22 quires otherwise by regulation, this section does not apply 

23 to any drug for an indication for which orphan designation 

24 has been granted under section 526. 

25 ‘‘(l) INSTITUTE OF MEDICINE STUDY.— 

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1 ‘‘(1) IN GENERAL.—Not later than three years 

2 after the date of the enactment of the Improving 

3 Pharmaceuticals for Children Act of 2007, the Sec4 retary shall contract with the Institute of Medicine 

5 to conduct a study and report to Congress regarding 

6 the pediatric studies conducted pursuant to this sec7 tion since 1997. 

8 ‘‘(2) CONTENT OF STUDY.—The study under 

9 paragraph (1) shall review and assess— 

10 ‘‘(A) pediatric studies conducted pursuant 

11 to this section since 1997 and labeling changes 

12 made as a result of such studies; and 

13 ‘‘(B) the use of extrapolation for pediatric 

14 subpopulations, the use of alternative endpoints 

15 for pediatric populations, neonatal assessment 

16 tools, the number and type of pediatric adverse 

17 events, and ethical issues in pediatric clinical 

18 trials. 

19 ‘‘(3) REPRESENTATIVE SAMPLE.—The Institute 

20 of Medicine may devise an appropriate mechanism to 

21 review a representative sample of studies conducted 

22 pursuant to this section from each review division 

23 within the Center for Drug Evaluation and Research 

24 in order to make the requested assessment.’’. 

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1 SEC. 4. GOVERNMENT ACCOUNTABILITY OFFICE REPORT. 

2 Not later than September 1, 2011, the Comptroller 

3 General of the United States, in consultation with the Sec4 retary of Health and Human Services, shall submit to 

5 Congress a report that addresses the effectiveness of sec6 tions 505A and 505B of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 355a) and section 409I of the Public 

8 Health Service Act (42 U.S.C. 284m) in ensuring that 

9 medicines used by children are tested and properly labeled. 

10 Such report shall include— 

11 (1) the number and importance of drugs and 

12 biological products for children that are being tested 

13 as a result of the amendments made by this Act and 

14 the importance for children, health care providers, 

15 parents, and others of labeling changes made as a 

16 result of such testing; 

17 (2) the number and importance of drugs and 

18 biological products for children that are not being 

19 tested for their use notwithstanding the provisions of 

20 this Act and possible reasons for the lack of testing, 

21 including whether the number of written requests 

22 declined by sponsors or holders of drugs subject to 

23 section 505A(g)(2) of the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 355a(g)(2)) has increased 

25 or decreased as a result of the amendments made by 

26 this Act; 

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1 (3) the number of drugs and biological products 

2 for which testing is being done and labeling changes 

3 required, including the date labeling changes are 

4 made and which labeling changes required the use of 

5 the dispute resolution process established pursuant 

6 to the amendments made by this Act, together with 

7 a description of the outcomes of such process, in8 cluding a description of the disputes and the rec9 ommendations of the Pediatric Advisory Committee; 

10 (4) any recommendations for modifications to 

11 the programs established under sections 505A and 

12 505B of the Federal Food, Drug, and Cosmetic Act 

13 (21 U.S.C. 355a) and section 409I of the Public 

14 Health Service Act (42 U.S.C. 284m) that the Sec15 retary determines to be appropriate, including a de16 tailed rationale for each recommendation; and 

17 (5)(A) the efforts made by the Secretary to in18 crease the number of studies conducted in the 

19 neonate population; and 

20 (B) the results of those efforts, including efforts 

21 made to encourage the conduct of appropriate stud22 ies in neonates by companies with products that 

23 have sufficient safety and other information to make 

24 the conduct of the studies ethical and safe. 

Æ 

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