II 

110TH CONGRESS 

1ST SESSION S. 1156 

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

Best Pharmaceuticals for Children program. 

IN THE SENATE OF THE UNITED STATES 

APRIL 18, 2007 

Mr. DODD (for himself, Mr. KENNEDY, Mr. HARKIN, Mr. BINGAMAN, Mrs. 

MURRAY, Mrs. CLINTON, and Mr. BROWN) 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 to 

reauthorize the Best Pharmaceuticals for Children program. 

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 ‘‘Best Pharmaceuticals 

5 for Children Amendments of 2007’’. 

6 SEC. 2. PEDIATRIC STUDIES OF DRUGS. 

7 (a) IN GENERAL.—Section 505A of the Federal 

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

9 amended— 

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1 (1) in subsection (a), by inserting before the pe2 riod at the end the following: ‘‘, and, at the discre3 tion of the Secretary, may include preclinical stud4 ies’’; 

5 (2) in subsection (b)— 

6 (A) in paragraph (1)(A)(i), by striking 

7 ‘‘(D)’’ both places it appears and inserting 

8 ‘‘(E)’’; 

9 (B) in paragraph (1)(A)(ii), by striking 

10 ‘‘(D)’’ and inserting ‘‘(E)’’; 

11 (C) by striking ‘‘(1)(A)(i)’’ and inserting 

12 ‘‘(A)(i)(I)’’; 

13 (D) by striking ‘‘(ii) the’’ and inserting 

14 ‘‘(II) the’’; 

15 (E) by striking ‘‘(B) if the drug is des16 ignated’’ and inserting ‘‘(ii) if the drug is des17 ignated’’; 

18 (F) by striking ‘‘(2)(A)’’ and inserting 

19 ‘‘(B)(i)’’; 

20 (G) by striking ‘‘(i) a listed patent’’ and 

21 inserting ‘‘(I) a listed patent’’; 

22 (H) by striking ‘‘(ii) a listed patent’’ and 

23 inserting ‘‘(II) a listed patent’’; 

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1 (I) by striking ‘‘(B) if the drug is the sub2 ject’’ and inserting ‘‘(ii) if the drug is the sub3 ject’’; 

4 (J) by striking ‘‘If’’ and all that follows 

5 through ‘‘subsection (d)(3)’’ and inserting the 

6 following: 

7 ‘‘(1) IN GENERAL.—Except as provided in para8 graph (2), if, prior to approval of an application that 

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

10 determines that information relating to the use of a 

11 new drug in the pediatric population may produce 

12 health benefits in that population, the Secretary 

13 makes a written request for pediatric studies (which 

14 shall include a timeframe for completing such stud15 ies), the applicant agrees to the request, such stud16 ies are completed using appropriate formulations for 

17 each age group for which the study is requested 

18 within any such timeframe and the reports thereof 

19 are submitted and accepted in accordance with sub20 section (d)(3), and if the Secretary determines that 

21 labeling changes are appropriate, such changes are 

22 made within the timeframe requested by the Sec23 retary—’’; and 

24 (K) by adding at the end the following: 

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1 ‘‘(2) EXCEPTION.—The Secretary shall not ex2 tend the period referred to in paragraph (1)(A) or 

3 in paragraph (1)(B) later than 9 months prior to 

4 the expiration of such period.’’; 

5 (3) in subsection (c)— 

6 (A) in paragraph (1)(A)(i), by striking 

7 ‘‘(D)’’ both places it appears and inserting 

8 ‘‘(E)’’; 

9 (B) in paragraph (1)(A)(ii), by striking 

10 ‘‘(D)’’ and inserting ‘‘(E)’’; 

11 (C) by striking ‘‘(1)(A)(i)’’ and inserting 

12 ‘‘(A)(i)(I)’’; 

13 (D) by striking ‘‘(ii) the’’ and inserting 

14 ‘‘(II) the’’; 

15 (E) by striking ‘‘(B) if the drug is des16 ignated’’ and inserting ‘‘(ii) if the drug is des17 ignated’’; 

18 (F) by striking ‘‘(2)(A)’’ and inserting 

19 ‘‘(B)(i)’’; 

20 (G) by striking ‘‘(i) a listed patent’’ and 

21 inserting ‘‘(I) a listed patent’’; 

22 (H) by striking ‘‘(ii) a listed patent’’ and 

23 inserting ‘‘(II) a listed patent’’; 

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1 (I) by striking ‘‘(B) if the drug is the sub2 ject’’ and inserting ‘‘(ii) if the drug is the sub3 ject’’; 

4 (J) by striking ‘‘If’’ and all that follows 

5 through ‘‘subsection (d)(3)’’ and inserting the 

6 following: 

7 ‘‘(1) IN GENERAL.—Except as provided in para8 graph (2), if the Secretary determines that informa9 tion relating to the use of an approved drug in the 

10 pediatric population may produce health benefits in 

11 that population and makes a written request to the 

12 holder of an approved application under section 

13 505(b)(1) for pediatric studies (which shall include 

14 a timeframe for completing such studies), the holder 

15 agrees to the request, such studies are completed 

16 using appropriate formulations for each age group 

17 for which the study is requested within any such 

18 timeframe and the reports thereof are submitted and 

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

20 the Secretary determines that labeling changes are 

21 appropriate, such changes are made within the time22 frame requested by the Secretary—’’; and 

23 (K) by adding at the end the following: 

24 ‘‘(2) EXCEPTION.—The Secretary shall not ex25 tend the period referred to in paragraph (1)(A) or 

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1 in paragraph (1)(B) later than 9 months prior to 

2 the expiration of such period.’’; 

3 (4) by striking subsection (d) and inserting the 

4 following: 

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

6 ‘‘(1) REQUEST FOR STUDIES.— 

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

8 after consultation with the sponsor of an appli9 cation for an investigational new drug under 

10 section 505(i), the sponsor of an application for 

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

12 holder of an approved application for a drug 

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

14 holder a written request for the conduct of pedi15 atric studies for such drug. In issuing such re16 quest, the Secretary shall take into account 

17 adequate representation of children of ethnic 

18 and racial minorities. Such request to conduct 

19 pediatric studies shall be in writing and shall 

20 include a timeframe for such studies and a re21 quest to the sponsor or holder to propose pedi22 atric labeling resulting from such studies. 

23 ‘‘(B) SINGLE WRITTEN REQUEST.—A sin24 gle written request— 

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1 ‘‘(i) may relate to more than 1 use of 

2 a drug; and 

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

4 approved and unapproved. 

5 ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUD6 IES.— 

7 ‘‘(A) REQUEST AND RESPONSE.— 

8 ‘‘(i) IN GENERAL.—If the Secretary 

9 makes a written request for pediatric stud10 ies (including neonates, as appropriate) 

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

12 or holder, not later than 180 days after re13 ceiving the written request, shall respond 

14 to the Secretary as to the intention of the 

15 applicant or holder to act on the request 

16 by— 

17 ‘‘(I) indicating when the pediatric 

18 studies will be initiated, if the appli19 cant or holder agrees to the request; 

20 or 

21 ‘‘(II) indicating that the appli22 cant or holder does not agree to the 

23 request and the reasons for declining 

24 the request. 

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1 ‘‘(ii) DISAGREE WITH REQUEST.—If, 

2 on or after the date of enactment of the 

3 Best Pharmaceuticals for Children Amend4 ments of 2007, the applicant or holder 

5 does not agree to the request on the 

6 grounds that it is not possible to develop 

7 the appropriate pediatric formulation, the 

8 applicant or holder shall submit to the Sec9 retary the reasons such pediatric formula10 tion cannot be developed. 

11 ‘‘(B) ADVERSE EVENT REPORTS.—An ap12 plicant or holder that, on or after the date of 

13 enactment of the Best Pharmaceuticals for 

14 Children Amendments of 2007, agrees to the 

15 request for such studies shall provide the Sec16 retary, at the same time as submission of the 

17 reports of such studies, with all postmarket ad18 verse event reports regarding the drug that is 

19 the subject of such studies and are available 

20 prior to submission of such reports. 

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

22 Not later than 180 days after the submission of the 

23 reports of the studies, the Secretary shall accept or 

24 reject such reports and so notify the sponsor or 

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1 ing or rejecting the reports shall be to determine, 

2 within the 180 days, whether the studies fairly re3 spond to the written request, have been conducted in 

4 accordance with commonly accepted scientific prin5 ciples and protocols, and have been reported in ac6 cordance with the requirements of the Secretary for 

7 filing. 

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

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

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

11 18, United States Code.’’; 

12 (5) by striking subsections (e) and (f) and in13 serting the following: 

14 ‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES RE15 QUIREMENT.— 

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

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

18 date of enactment of the Best Pharmaceuticals for 

19 Children Amendments of 2007, that the require20 ments of subsection (d) have been met and that sub21 missions and approvals under subsection (b)(2) or 

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

23 provisions of this section. Such notice shall be pub24 lished not later than 30 days after the date of the 

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1 sivity and shall include a copy of the written request 

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

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

4 The Secretary shall publish a notice identifying any 

5 drug for which, on or after the date of enactment of 

6 the Best Pharmaceuticals for Children Amendments 

7 of 2007, a pediatric formulation was developed, 

8 studied, and found to be safe and effective in the pe9 diatric population (or specified subpopulation) if the 

10 pediatric formulation for such drug is not introduced 

11 onto the market within 1 year of the date that the 

12 Secretary publishes the notice described in para13 graph (1). Such notice identifying such drug shall be 

14 published not later than 30 days after the date of 

15 the expiration of such 1 year period. 

16 ‘‘(f) INTERNAL REVIEW OF WRITTEN REQUESTS

17 AND PEDIATRIC STUDIES.— 

18 ‘‘(1) INTERNAL REVIEW.— 

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

20 create an internal review committee to review 

21 all written requests issued and all reports sub22 mitted on or after the date of enactment of the 

23 Best Pharmaceuticals for Children Amendments 

24 of 2007, in accordance with paragraphs (2) and 

25 (3). 

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1 ‘‘(B) MEMBERS.—The committee under 

2 subparagraph (A) shall include individuals, each 

3 of whom is an employee of the Food and Drug 

4 Administration, with the following expertise: 

5 ‘‘(i) Pediatrics. 

6 ‘‘(ii) Biopharmacology. 

7 ‘‘(iii) Statistics. 

8 ‘‘(iv) Drugs and drug formulations. 

9 ‘‘(v) Legal issues. 

10 ‘‘(vi) Appropriate expertise pertaining 

11 to the pediatric product under review. 

12 ‘‘(vii) One or more experts from the 

13 Office of Pediatric Therapeutics, including 

14 an expert in pediatric ethics. 

15 ‘‘(viii) Other individuals as designated 

16 by the Secretary. 

17 ‘‘(2) REVIEW OF WRITTEN REQUESTS.—All 

18 written requests under this section shall be reviewed 

19 and approved by the committee established under 

20 paragraph (1) prior to being issued. 

21 ‘‘(3) REVIEW OF PEDIATRIC STUDIES.—The 

22 committee established under paragraph (1) shall re23 view all studies conducted pursuant to this section to 

24 determine whether to accept or reject such reports 

25 under subsection (d)(3). 

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1 ‘‘(4) TRACKING PEDIATRIC STUDIES AND LA2 BELING CHANGES.—The committee established 

3 under paragraph (1) shall be responsible for track4 ing and making available to the public, in an easily 

5 accessible manner, including through posting on the 

6 website of the Food and Drug Administration— 

7 ‘‘(A) the number of studies conducted 

8 under this section; 

9 ‘‘(B) the specific drugs and drug uses, in10 cluding labeled and off-labeled indications, stud11 ied under this section; 

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

13 this section, including trial design, the number 

14 of pediatric patients studied, and the number of 

15 centers and countries involved; 

16 ‘‘(D) the number of pediatric formulations 

17 developed and the number of pediatric formula18 tions not developed and the reasons such for19 mulations were not developed; 

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

21 of studies conducted under this section; 

22 ‘‘(F) an annual summary of labeling 

23 changes made as a result of studies conducted 

24 under this section for distribution pursuant to 

25 subsection (k)(2); and 

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1 ‘‘(G) information regarding reports sub2 mitted on or after the date of enactment of the 

3 Best Pharmaceuticals for Children Amendments 

4 of 2007.’’; 

5 (6) in subsection (g)— 

6 (A) in paragraph (1)— 

7 (i) by striking ‘‘(c)(1)(A)(ii)’’ and in8 serting ‘‘(c)(1)(A)(i)(II)’’; and 

9 (ii) by striking ‘‘(c)(2)’’ and inserting 

10 ‘‘(c)(1)(B)’’; 

11 (B) in paragraph (2), by striking 

12 ‘‘(c)(1)(B)’’ and inserting ‘‘(c)(1)(A)(ii)’’; 

13 (C) by redesignating paragraphs (1) and 

14 (2) as subparagraphs (A) and (B), respectively; 

15 (D) by striking ‘‘LIMITATIONS.—A drug’’ 

16 and inserting ‘‘LIMITATIONS.— 

17 ‘‘(1) IN GENERAL.—Notwithstanding subsection 

18 (c)(2), a drug’’; and 

19 (E) by adding at the end the following: 

20 ‘‘(2) EXCLUSIVITY ADJUSTMENT.— 

21 ‘‘(A) ADJUSTMENT.— 

22 ‘‘(i) IN GENERAL.—With respect to 

23 any drug, if the organization designated 

24 under subparagraph (B) notifies the Sec25 retary that the combined annual gross 

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1 sales for all drugs with the same active 

2 moiety exceeded $1,000,000,000 in any 

3 calendar year prior to the time the sponsor 

4 or holder agrees to the initial written re5 quest pursuant to subsection (d)(2), then 

6 each period of market exclusivity deemed 

7 or extended under subsection (b) or (c) 

8 shall be reduced by 3 months for such 

9 drug. 

10 ‘‘(ii) DETERMINATION.—The deter11 mination under clause (i) of the combined 

12 annual gross sales shall be determined— 

13 ‘‘(I) taking into account only 

14 those sales within the United States; 

15 and 

16 ‘‘(II) taking into account only the 

17 sales of all drugs with the same active 

18 moiety of the sponsor or holder and 

19 its affiliates. 

20 ‘‘(B) DESIGNATION.—The Secretary shall 

21 designate an organization other than the Food 

22 and Drug Administration to evaluate whether 

23 the combined annual gross sales for all drugs 

24 with the same active moiety exceeded 

25 $1,000,000,000 in a calendar year as described 

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1 in subparagraph (A). Prior to designating such 

2 organization, the Secretary shall determine that 

3 such organization is independent and is quali4 fied to evaluate the sales of pharmaceutical 

5 products. The Secretary shall re-evaluate the 

6 designation of such organization once every 3 

7 years. 

8 ‘‘(C) NOTIFICATION.—Once a year at a 

9 time designated by the Secretary, the organiza10 tion designated under subparagraph (B) shall 

11 notify the Food and Drug Administration of all 

12 drugs with the same active moiety with com13 bined annual gross sales that exceed 

14 $1,000,000,000 during the previous calendar 

15 year.’’. 

16 (7) in subsection (i)— 

17 (A) in the heading, by striking ‘‘SUPPLE18 MENTS’’ and inserting ‘‘CHANGES’’; 

19 (B) in paragraph (1)— 

20 (i) in the heading, by inserting ‘‘AP21 PLICATIONS AND’’ after ‘‘PEDIATRIC’’; 

22 (ii) by inserting ‘‘application or’’ after 

23 ‘‘Any’’; 

24 (iii) by striking ‘‘change pursuant to a 

25 report on a pediatric study under’’ and inmstockstill on PROD1PC66 with BILLS

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1 serting ‘‘change as a result of any pedi2 atric study conducted pursuant to’’; and 

3 (iv) by inserting ‘‘application or’’ after 

4 ‘‘to be a priority’’; and 

5 (C) in paragraph (2)(A), by— 

6 (i) striking ‘‘If the Commissioner’’ 

7 and inserting ‘‘If, on or after the date of 

8 enactment of the Best Pharmaceuticals for 

9 Children Amendments of 2007, the Com10 missioner’’; and 

11 (ii) striking ‘‘an application with’’ and 

12 all that follows through ‘‘on appropriate’’ 

13 and inserting ‘‘the sponsor and the Com14 missioner have been unable to reach agree15 ment on appropriate’’; 

16 (8) by striking subsection (m); 

17 (9) by redesignating subsections (j), (k), (l), 

18 and (n), as subsections (k), (m), (o), and (p), respec19 tively; 

20 (10) by inserting after subsection (i) the fol21 lowing: 

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

23 date of enactment of the Best Pharmaceuticals for Chil24 dren Amendments of 2007, the Secretary determines that 

25 a pediatric study conducted under this section does or does 

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

2 study is safe and effective, including whether such study 

3 results are inconclusive, in pediatric populations or sub4 populations, the Secretary shall order the labeling of such 

5 product to include information about the results of the 

6 study and a statement of the Secretary’s determination.’’; 

7 (11) in subsection (k), as redesignated by para8 graph (9)— 

9 (A) in paragraph (1)— 

10 (i) by striking ‘‘a summary of the 

11 medical and’’ and inserting ‘‘the medical, 

12 statistical, and’’; and 

13 (ii) by striking ‘‘for the supplement’’ 

14 and all that follows through the period and 

15 inserting ‘‘under subsection (b) or (c).’’; 

16 (B) by redesignating paragraph (2) as 

17 paragraph (3); and 

18 (C) by inserting after paragraph (1) the 

19 following: 

20 ‘‘(2) DISSEMINATION OF INFORMATION RE21 GARDING LABELING CHANGES.—Beginning on the 

22 date of enactment of the Best Pharmaceuticals for 

23 Children Amendments of 2007, the Secretary shall 

24 require that the sponsors of the studies that result 

25 in labeling changes that are reflected in the annual 

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1 summary developed pursuant to subsection (f)(4)(F) 

2 distribute, at least annually (or more frequently if 

3 the Secretary determines that it would be beneficial 

4 to the public health), such information to physicians 

5 and other health care providers.’’; 

6 (12) by inserting after subsection (k), as redes7 ignated by paragraph (9), the following: 

8 ‘‘(l) ADVERSE EVENT REPORTING.— 

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

10 the date of enactment of the Best Pharmaceuticals 

11 for Children Amendments of 2007, during the 1-year 

12 period beginning on the date a labeling change is 

13 made pursuant to subsection (i), the Secretary shall 

14 ensure that all adverse event reports that have been 

15 received for such drug (regardless of when such re16 port was received) are referred to the Office of Pedi17 atric Therapeutics established under section 6 of the 

18 Best Pharmaceuticals for Children Act (Public Law 

19 107–109). In considering such reports, the Director 

20 of such Office shall provide for the review of the re21 port by the Pediatric Advisory Committee, including 

22 obtaining any recommendations of such Committee 

23 regarding whether the Secretary should take action 

24 under this section in response to such reports. 

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

3 the Secretary shall, as appropriate, refer to the Of4 fice 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 

7 such reports, the Director of such Office may pro8 vide for the review of such reports by the Pediatric 

9 Advisory Committee, including obtaining any rec10 ommendation of such Committee regarding whether 

11 the Secretary should take action in response to such 

12 reports. 

13 ‘‘(3) EFFECT.—The requirements of this sub14 section shall supplement, not supplant, other review 

15 of such adverse event reports by the Secretary.’’; 

16 (13) by inserting after subsection (m), as redes17 ignated by paragraph (9), the following: 

18 ‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COM19 PLETED.— 

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

21 enactment of the Best Pharmaceuticals for Children 

22 Amendments of 2007, if pediatric studies of a drug 

23 have not been completed under subsection (d) and if 

24 the Secretary, through the committee established 

25 under subsection (f), determines that there is a conmstockstill on PROD1PC66 with BILLS

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1 tinuing need for information relating to the use of 

2 the drug in the pediatric population (including neo3 nates, as appropriate), the Secretary shall carry out 

4 the following: 

5 ‘‘(A) For a drug for which a listed patent 

6 has not expired, make a determination regard7 ing whether an assessment shall be required to 

8 be submitted under section 505B. Prior to mak9 ing such determination, the Secretary may take 

10 not more than 60 days to certify whether the 

11 Foundation for the National Institutes of 

12 Health has sufficient funding at the time of 

13 such certification to initiate 1 or more of the 

14 pediatric studies of such drug referred to in the 

15 sentence preceding this paragraph and fund 1 

16 or more of such studies in their entirety. Only 

17 if the Secretary makes such certification in the 

18 affirmative, the Secretary shall refer such pedi19 atric study or studies to the Foundation for the 

20 National Institutes of Health for the conduct of 

21 such study or studies. 

22 ‘‘(B) For a drug that has no listed patents 

23 or has 1 or more listed patents that have ex24 pired, determine whether there are funds avail25 able under section 736 to award a grant to conmstockstill on PROD1PC66 with BILLS

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1 duct the requested studies pursuant to para2 graph (2). 

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

4 paragraph (1), the Secretary determines that there 

5 are funds available under section 736 to award a 

6 grant to conduct the requested pediatric studies, 

7 then the Secretary shall issue a proposal to award 

8 a grant to conduct the requested studies. If the Sec9 retary determines that funds are not available under 

10 section 736, the Secretary shall refer the drug for 

11 inclusion on the list established under section 409I 

12 of the Public Health Service Act for the conduct of 

13 studies. 

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

15 the public notice of— 

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

17 not to require an assessment under section 

18 505B and the basis for such decision; 

19 ‘‘(B) the name of any drug, its manufac20 turer, and the indications to be studied pursu21 ant to a grant made under paragraph (2); and 

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

23 refer a drug for inclusion on the list established 

24 under section 409I of the Public Health Service 

25 Act. 

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

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

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

4 18, United States Code.’’; and 

5 (14) in subsection (p), as redesignated by para6 graph (9)— 

7 (A) striking ‘‘6-month period’’ and insert8 ing ‘‘3-month or 6-month period’’; 

9 (B) by striking ‘‘subsection (a)’’ and in10 serting ‘‘subsection (b)’’; and 

11 (C) by striking ‘‘2007’’ both places it ap12 pears and inserting ‘‘2012’’. 

13 (b) EFFECTIVE DATE.—Except as otherwise provided 

14 in the amendments made by subsection (a), such amend15 ments shall apply to written requests under section 505A 

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

17 355a) made after the date of enactment of this Act. 

18 SEC. 3. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 

19 Section 409I of the Public Health Service Act (42 

20 U.S.C. 284m) is amended— 

21 (1) by striking subsections (a) and (b) and in22 serting the following: 

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

24 THERAPEUTICS.— 

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

2 the date of enactment of the Best Pharmaceuticals 

3 for Children Amendments of 2007, the Secretary, 

4 acting through the Director of the National Insti5 tutes of Health and in consultation with the Com6 missioner of Food and Drugs and experts in pedi7 atric research, shall develop and publish a priority 

8 list of needs in pediatric therapeutics, including 

9 drugs or indications that require study. The list 

10 shall be revised every 3 years. 

11 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA12 TION.—In developing and prioritizing the list under 

13 paragraph (1), the Secretary shall consider— 

14 ‘‘(A) therapeutic gaps in pediatrics that 

15 may include developmental pharmacology, 

16 pharmacogenetic determinants of drug re17 sponse, metabolism of drugs and biologics in 

18 children, and pediatric clinical trials; 

19 ‘‘(B) particular pediatric diseases, dis20 orders or conditions where more complete 

21 knowledge and testing of therapeutics, including 

22 drugs and biologics, may be beneficial in pedi23 atric populations; and 

24 ‘‘(C) the adequacy of necessary infrastruc25 ture to conduct pediatric pharmacological remstockstill on PROD1PC66 with BILLS

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1 search, including research networks and trained 

2 pediatric investigators. 

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

4 Secretary, acting through the National Institutes of 

5 Health, shall award funds to entities that have the exper6 tise to conduct pediatric clinical trials or other research 

7 (including qualified universities, hospitals, laboratories, 

8 contract research organizations, practice groups, federally 

9 funded programs such as pediatric pharmacology research 

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

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

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

13 Secretary may use contracts, grants, or other appropriate 

14 funding mechanisms to award funds under this sub15 section.’’; 

16 (2) in subsection (c)— 

17 (A) in the heading, by striking ‘‘CON18 TRACTS’’ and inserting ‘‘PROPOSED PEDIATRIC

19 STUDY REQUESTS’’; 

20 (B) by striking paragraphs (4) and (12); 

21 (C) by redesignating paragraphs (1), (2), 

22 and (3), as paragraphs (2), (3), and (4); 

23 (D) by inserting before paragraph (2), as 

24 redesignated by subparagraph (C), the fol25 lowing: 

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1 ‘‘(1) SUBMISSION OF PROPOSED PEDIATRIC

2 STUDY REQUEST.—The Director of the National In3 stitutes of Health shall, as appropriate, submit pro4 posed pediatric study requests for consideration by 

5 the Commissioner of Food and Drugs for pediatric 

6 studies of a specific pediatric indication identified 

7 under subsection (a). Such a proposed pediatric 

8 study request shall be made in a manner equivalent 

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

10 (c) of section 505A of the Federal Food, Drug, and 

11 Cosmetic Act, including with respect to the informa12 tion provided on the pediatric studies to be con13 ducted pursuant to the request. The Director of the 

14 National Institutes of Health may submit a pro15 posed pediatric study request for a drug for which— 

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

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

18 Drug, and Cosmetic Act; or 

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

20 could be approved under the criteria of section 

21 505(j) of the Federal Food, Drug, and Cos22 metic Act; 

23 ‘‘(B) there is no patent protection or mar24 ket exclusivity protection for at least 1 form of 

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1 the drug under the Federal Food, Drug, and 

2 Cosmetic Act; and 

3 ‘‘(C) additional studies are needed to as4 sess the safety and effectiveness of the use of 

5 the drug in the pediatric population.’’; 

6 (E) in paragraph (2), as redesignated by 

7 subparagraph (C)— 

8 (i) by inserting ‘‘based on the pro9 posed pediatric study request for the indi10 cation or indications submitted pursuant to 

11 paragraph (1)’’ after ‘‘issue a written re12 quest’’; 

13 (ii) by striking ‘‘in the list described 

14 in subsection (a)(1)(A) (except clause 

15 (iv))’’ and inserting ‘‘under subsection 

16 (a)’’; and 

17 (iii) by inserting ‘‘and using appro18 priate formulations for each age group for 

19 which the study is requested’’ before the 

20 period at the end; 

21 (F) in paragraph (3), as redesignated by 

22 subparagraph (C)— 

23 (i) in the heading, by striking ‘‘CON24 TRACTS’’; 

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1 (ii) by striking ‘‘paragraph (1)’’ and 

2 inserting ‘‘paragraph (2)’’; 

3 (iii) by striking ‘‘or if a referral de4 scribed in subsection (a)(1)(A)(iv) is 

5 made,’’; 

6 (iv) by striking ‘‘for contract pro7 posals’’ and inserting ‘‘for proposals’’; and 

8 (v) by inserting ‘‘in accordance with 

9 subsection (b)’’ before the period at the 

10 end; 

11 (G) in paragraph (4), as redesignated by 

12 subparagraph (C)— 

13 (i) by striking ‘‘contract’’; and 

14 (ii) by striking ‘‘paragraph (2)’’ and 

15 inserting ‘‘paragraph (3)’’; 

16 (H) in paragraph (5)— 

17 (i) by striking the heading and insert18 ing ‘‘CONTRACTS, GRANTS, OR OTHER

19 FUNDING MECHANISMS’’; and 

20 (ii) by striking ‘‘A contract’’ and all 

21 that follows through ‘‘is submitted’’ and 

22 inserting ‘‘A contract, grant, or other 

23 funding may be awarded under this section 

24 only if a proposal is submitted’’; 

25 (I) in paragraph (6)(A)— 

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1 (i) by striking ‘‘a contract awarded’’ 

2 and inserting ‘‘an award’’; and 

3 (ii) by inserting ‘‘, including a written 

4 request if issued’’ after ‘‘with the study’’; 

5 and 

6 (3) by inserting after subsection (c) the fol7 lowing: 

8 ‘‘(d) DISSEMINATION OF PEDIATRIC INFORMA9 TION.—Not later than 1 year after the date of enactment 

10 of the Best Pharmaceuticals for Children Amendments of 

11 2007, the Secretary, acting through the Director of the 

12 National Institutes of Health, shall study the feasibility 

13 of establishing a compilation of information on pediatric 

14 drug use and report the findings to Congress.’’ 

15 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 

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

17 appropriated to carry out this section— 

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

19 and 

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

21 of the 4 succeeding fiscal years. 

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

23 under paragraph (1) shall remain available to carry 

24 out this section until expended.’’. 

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1 SEC. 4. REPORTS AND STUDIES. 

2 (a) GAO REPORT.—Not later than January 31, 

3 2011, the Comptroller General of the United States, in 

4 consultation with the Secretary of Health and Human 

5 Services, shall submit to Congress a report that addresses 

6 the effectiveness of section 505A of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355a) in ensuring 

8 that medicines used by children are tested and properly 

9 labeled, including— 

10 (1) the number and importance of drugs for 

11 children that are being tested as a result of the 

12 amendments made by this Act and the importance 

13 for children, health care providers, parents, and oth14 ers of labeling changes made as a result of such 

15 testing; 

16 (2) the number and importance of drugs for 

17 children that are not being tested for their use not18 withstanding the provisions of this Act and the 

19 amendments made by this Act, and possible reasons 

20 for the lack of testing, including whether the number 

21 of written requests declined by sponsors or holders 

22 of drugs subject to section 505A(g)(2) of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

24 355a(g)(2)), has increased or decreased as a result 

25 of the amendments made by this Act; 

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1 (3) the number of drugs for which testing is 

2 being done and labeling changes required, including 

3 the date labeling changes are made and which label4 ing changes required the use of the dispute resolu5 tion process established pursuant to the amendments 

6 made by this Act, together with a description of the 

7 outcomes of such process, including a description of 

8 the disputes and the recommendations of the Pedi9 atric Advisory Committee; 

10 (4) any recommendations for modifications to 

11 the programs established under section 505A of the 

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

13 355a) and section 409I of the Public Health Service 

14 Act that the Secretary determines to be appropriate, 

15 including a detailed rationale for each recommenda16 tion; 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. 

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1 (b) IOM STUDY.—Not later than 3 years after the 

2 date of enactment of this Act, the Secretary of Health and 

3 Human Services shall enter into a contract with the Insti4 tute of Medicine to conduct a study and report to Con5 gress regarding the written requests made and the studies 

6 conducted pursuant to section 505A of the Federal Food, 

7 Drug, and Cosmetic Act. The Institute of Medicine may 

8 devise an appropriate mechanism to review a representa9 tive sample of requests made and studies conducted pursu10 ant to such section in order to conduct such study. Such 

11 study shall— 

12 (1) review such representative written requests 

13 issued by the Secretary since 1997 under sub14 sections (b) and (c) of such section 505A; 

15 (2) review and assess such representative pedi16 atric studies conducted under such subsections (b) 

17 and (c) since 1997 and labeling changes made as a 

18 result of such studies; and 

19 (3) review the use of extrapolation for pediatric 

20 subpopulations, the use of alternative endpoints for 

21 pediatric populations, neonatal assessment tools, and 

22 ethical issues in pediatric clinical trials. 

23 SEC. 5. TRAINING OF PEDIATRIC PHARMACOLOGISTS. 

24 (a) INVESTMENT IN TOMORROW’S PEDIATRIC RE25 SEARCHERS.—Section 452G(2) of the Public Health Servmstockstill on PROD1PC66 with BILLS

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1 ice Act (42 U.S.C. 285g–10(2)) is amended by adding be2 fore the period at the end the following: ‘‘, including pedi3 atric pharmacological research’’. 

4 (b) PEDIATRIC RESEARCH LOAN REPAYMENT PRO5 GRAM.—Section 487F(a)(1) of the Public Health Service 

6 Act (42 U.S.C. 288–6(a)(1)) is amended by inserting ‘‘in7 cluding pediatric pharmacological research,’’ after ‘‘pedi8 atric research,’’. 

9 SEC. 6. FOUNDATION FOR THE NATIONAL INSTITUTES OF 

10 HEALTH. 

11 Section 499(c)(1)(C) of the Public Health Service Act 

12 (42 U.S.C. 290b(c)(1)(C)) is amended by striking ‘‘and 

13 studies listed by the Secretary pursuant to section 

14 409I(a)(1)(A) of the is Act and referred under section 

15 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic 

16 Act (21 U.S.C. 355(a)(d)(4)(C)’’ and inserting ‘‘and stud17 ies for which the Secretary issues a certification under sec18 tion 505A(n)(1)(A) of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 355a(n)(1)(A))’’. 

20 SEC. 7. CONTINUATION OF OPERATION OF COMMITTEE. 

21 Section 14 of the Best Pharmaceuticals for Children 

22 Act (42 U.S.C. 284m note) is amended by adding at the 

23 end the following: 

24 ‘‘(d) CONTINUATION OF OPERATION OF COM25 MITTEE.—Notwithstanding section 14 of the Federal Admstockstill on PROD1PC66 with BILLS

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1 visory Committee Act (5 U.S.C. App.), the advisory com2 mittee shall continue to operate during the 5-year period 

3 beginning on the date of enactment of the Best Pharma4 ceuticals for Children Amendments of 2007.’’. 

5 SEC. 8. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC 

6 DRUGS ADVISORY COMMITTEE. 

7 Section 15 of the Best Pharmaceuticals for Children 

8 Act (42 U.S.C. 284m note) is amended— 

9 (1) in subsection (a)— 

10 (A) in paragraph (1)— 

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

12 ‘‘and’’ after the semicolon; 

13 (ii) in subparagraph (C), by striking 

14 the period at the end and inserting ‘‘; 

15 and’’; and 

16 (iii) by adding at the end the fol17 lowing: 

18 ‘‘(D) provide recommendations to the in19 ternal review committee created under section 

20 505A(f) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 355a(f)) regarding the 

22 implementation of amendments to sections 

23 505A and 505B of the Federal Food, Drug, 

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

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1 with respect to the treatment of pediatric can2 cers.’’; and 

3 (B) by adding at the end the following: 

4 ‘‘(3) CONTINUATION OF OPERATION OF SUB5 COMMITTEE.—Notwithstanding section 14 of the 

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

7 the Subcommittee shall continue to operate during 

8 the 5-year period beginning on the date of enact9 ment of the Best Pharmaceuticals for Children 

10 Amendments of 2007.’’; and 

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

12 inserting ‘‘2009’’. 

13 SEC. 9. EFFECTIVE DATE AND LIMITATION FOR RULE RE14 LATING TO TOLL-FREE NUMBER FOR AD15 VERSE EVENTS ON LABELING FOR HUMAN 

16 DRUG PRODUCTS. 

17 (a) IN GENERAL.—Notwithstanding subchapter II of 

18 chapter 5, and chapter 7, of title 5, United States Code 

19 (commonly known as the ‘‘Administrative Procedure Act’’) 

20 and any other provision of law, the proposed rule issued 

21 by the Commissioner of Food and Drugs entitled ‘‘Toll22 Free Number for Reporting Adverse Events on Labeling 

23 for Human Drug Products’’, 69 Fed. Reg. 21778, (April 

24 22, 2004) shall take effect on January 1, 2008, unless 

25 such Commissioner issues the final rule before such date. 

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1 (b) LIMITATION.—The proposed rule that takes ef2 fect under subsection (a), or the final rule described under 

3 subsection (a), shall, notwithstanding section 17(a) of the 

4 Best Pharmaceuticals for Children Act (21 U.S.C. 

5 355b(a)), not apply to a drug— 

6 (1) for which an application is approved under 

7 section 505 of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 355); 

9 (2) that is not described under section 

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

11 (3) the packaging of which includes a toll-free 

12 number through which consumers can report com13 plaints to the manufacturer or distributor of the 

14 drug. 

Æ 

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