II 110th CONGRESS 1st Session S. 1156 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.

Short title

This Act may be cited as the Best Pharmaceuticals for Children Amendments of 2007.

2.

Pediatric studies of drugs

(a)

In general

Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended— (1)in subsection (a), by inserting before the period at the end the following: , and, at the discretion of the Secretary, may include preclinical studies; (2)in subsection (b)— (A)in paragraph (1)(A)(i), by striking (D) both places it appears and inserting (E); (B)in paragraph (1)(A)(ii), by striking (D) and inserting (E); (C)by striking (1)(A)(i) and inserting (A)(i)(I); (D)by striking (ii) the and inserting (II) the; (E)by striking (B) if the drug is designated and inserting (ii) if the drug is designated; (F)by striking (2)(A) and inserting (B)(i); (G)by striking (i) a listed patent and inserting (I) a listed patent; (H)by striking (ii) a listed patent and inserting (II) a listed patent; (I)by striking (B) if the drug is the subject and inserting (ii) if the drug is the subject; (J)by striking If and all that follows through subsection (d)(3) and inserting the following: (1)

In general

Except as provided in paragraph (2), if, prior to approval of an application that is submitted under section 505(b)(1), the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe and the reports thereof are submitted and accepted in accordance with subsection (d)(3), and if the Secretary determines that labeling changes are appropriate, such changes are made within the timeframe requested by the Secretary— ; and (K)by adding at the end the following: (2)

Exception

The Secretary shall not extend the period referred to in paragraph (1)(A) or in paragraph (1)(B) later than 9 months prior to the expiration of such period. ; (3)in subsection (c)— (A)in paragraph (1)(A)(i), by striking (D) both places it appears and inserting (E); (B)in paragraph (1)(A)(ii), by striking (D) and inserting (E); (C)by striking (1)(A)(i) and inserting (A)(i)(I); (D)by striking (ii) the and inserting (II) the; (E)by striking (B) if the drug is designated and inserting (ii) if the drug is designated; (F)by striking (2)(A) and inserting (B)(i); (G)by striking (i) a listed patent and inserting (I) a listed patent; (H)by striking (ii) a listed patent and inserting (II) a listed patent; (I)by striking (B) if the drug is the subject and inserting (ii) if the drug is the subject; (J)by striking If and all that follows through subsection (d)(3) and inserting the following: (1)

In general

Except as provided in paragraph (2), if the Secretary determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and makes a written request to the holder of an approved application under section 505(b)(1) for pediatric studies (which shall include a timeframe for completing such studies), the holder agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe and the reports thereof are submitted and accepted in accordance with subsection (d)(3), and if the Secretary determines that labeling changes are appropriate, such changes are made within the timeframe requested by the Secretary— ; and (K)by adding at the end the following: (2)

Exception

The Secretary shall not extend the period referred to in paragraph (1)(A) or in paragraph (1)(B) later than 9 months prior to the expiration of such period. ; (4)by striking subsection (d) and inserting the following: (d)

Conduct of pediatric studies

(1)

Request for studies

(A)

In general

The Secretary may, after consultation with the sponsor of an application for an investigational new drug under section 505(i), the sponsor of an application for a new drug under section 505(b)(1), or the holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take into account adequate representation of children of ethnic and racial minorities. Such request to conduct pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the sponsor or holder to propose pediatric labeling resulting from such studies. (B)

Single written request

A single written request— (i)may relate to more than 1 use of a drug; and (ii)may include uses that are both approved and unapproved. (2)

Written request for pediatric studies

(A)

Request and response

(i)

In general

If the Secretary makes a written request for pediatric studies (including neonates, as appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after receiving the written request, shall respond to the Secretary as to the intention of the applicant or holder to act on the request by— (I)indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the request; or (II)indicating that the applicant or holder does not agree to the request and the reasons for declining the request. (ii)

Disagree with request

If, on or after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, the applicant or holder does not agree to the request on the grounds that it is not possible to develop the appropriate pediatric formulation, the applicant or holder shall submit to the Secretary the reasons such pediatric formulation cannot be developed. (B)

Adverse event reports

An applicant or holder that, on or after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, agrees to the request for such studies shall provide the Secretary, at the same time as submission of the reports of such studies, with all postmarket adverse event reports regarding the drug that is the subject of such studies and are available prior to submission of such reports. (3)

Meeting the studies requirement

Not later than 180 days after the submission of the reports of the studies, the Secretary shall accept or reject such reports and so notify the sponsor or holder. The Secretary’s only responsibility in accepting or rejecting the reports shall be to determine, within the 180 days, whether the studies fairly respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with the requirements of the Secretary for filing. (4)

Effect of subsection

Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code. ; (5)by striking subsections (e) and (f) and inserting the following: (e)

Notice of determinations on studies requirement

(1)

In general

The Secretary shall publish a notice of any determination, made on or after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, that the requirements of subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section 505 for a drug will be subject to the provisions of this section. Such notice shall be published not later than 30 days after the date of the Secretary’s determination regarding market exclusivity and shall include a copy of the written request made under subsection (b) or (c). (2)

Identification of certain drugs

The Secretary shall publish a notice identifying any drug for which, on or after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population (or specified subpopulation) if the pediatric formulation for such drug is not introduced onto the market within 1 year of the date that the Secretary publishes the notice described in paragraph (1). Such notice identifying such drug shall be published not later than 30 days after the date of the expiration of such 1 year period. (f)

Internal review of written requests and pediatric studies

(1)

Internal review

(A)

In general

The Secretary shall create an internal review committee to review all written requests issued and all reports submitted on or after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, in accordance with paragraphs (2) and (3). (B)

Members

The committee under subparagraph (A) shall include individuals, each of whom is an employee of the Food and Drug Administration, with the following expertise: (i)Pediatrics. (ii)Biopharmacology. (iii)Statistics. (iv)Drugs and drug formulations. (v)Legal issues. (vi)Appropriate expertise pertaining to the pediatric product under review. (vii)One or more experts from the Office of Pediatric Therapeutics, including an expert in pediatric ethics. (viii)Other individuals as designated by the Secretary. (2)

Review of written requests

All written requests under this section shall be reviewed and approved by the committee established under paragraph (1) prior to being issued. (3)

Review of pediatric studies

The committee established under paragraph (1) shall review all studies conducted pursuant to this section to determine whether to accept or reject such reports under subsection (d)(3). (4)

Tracking pediatric studies and labeling changes

The committee established under paragraph (1) shall be responsible for tracking and making available to the public, in an easily accessible manner, including through posting on the website of the Food and Drug Administration— (A)the number of studies conducted under this section; (B)the specific drugs and drug uses, including labeled and off-labeled indications, studied under this section; (C)the types of studies conducted under this section, including trial design, the number of pediatric patients studied, and the number of centers and countries involved; (D)the number of pediatric formulations developed and the number of pediatric formulations not developed and the reasons such formulations were not developed; (E)the labeling changes made as a result of studies conducted under this section; (F)an annual summary of labeling changes made as a result of studies conducted under this section for distribution pursuant to subsection (k)(2); and (G)information regarding reports submitted on or after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007. ; (6)in subsection (g)— (A)in paragraph (1)— (i)by striking (c)(1)(A)(ii) and inserting (c)(1)(A)(i)(II); and (ii)by striking (c)(2) and inserting (c)(1)(B); (B)in paragraph (2), by striking (c)(1)(B) and inserting (c)(1)(A)(ii); (C)by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively; (D)by striking Limitations.—A drug and inserting Limitations.—(1)

In general

Notwithstanding subsection (c)(2), a drug ; and (E)by adding at the end the following: (2)

Exclusivity adjustment

(A)

Adjustment

(i)

In general

With respect to any drug, if the organization designated under subparagraph (B) notifies the Secretary that the combined annual gross sales for all drugs with the same active moiety exceeded $1,000,000,000 in any calendar year prior to the time the sponsor or holder agrees to the initial written request pursuant to subsection (d)(2), then each period of market exclusivity deemed or extended under subsection (b) or (c) shall be reduced by 3 months for such drug. (ii)

Determination

The determination under clause (i) of the combined annual gross sales shall be determined— (I)taking into account only those sales within the United States; and (II)taking into account only the sales of all drugs with the same active moiety of the sponsor or holder and its affiliates. (B)

Designation

The Secretary shall designate an organization other than the Food and Drug Administration to evaluate whether the combined annual gross sales for all drugs with the same active moiety exceeded $1,000,000,000 in a calendar year as described in subparagraph (A). Prior to designating such organization, the Secretary shall determine that such organization is independent and is qualified to evaluate the sales of pharmaceutical products. The Secretary shall re-evaluate the designation of such organization once every 3 years. (C)

Notification

Once a year at a time designated by the Secretary, the organization designated under subparagraph (B) shall notify the Food and Drug Administration of all drugs with the same active moiety with combined annual gross sales that exceed $1,000,000,000 during the previous calendar year. . (7)in subsection (i)— (A)in the heading, by striking Supplements and inserting Changes; (B)in paragraph (1)— (i)in the heading, by inserting applications and after pediatric; (ii)by inserting application or after Any; (iii)by striking change pursuant to a report on a pediatric study under and inserting change as a result of any pediatric study conducted pursuant to; and (iv)by inserting application or after to be a priority; and (C)in paragraph (2)(A), by— (i)striking If the Commissioner and inserting If, on or after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, the Commissioner; and (ii)striking an application with and all that follows through on appropriate and inserting the sponsor and the Commissioner have been unable to reach agreement on appropriate; (8)by striking subsection (m); (9)by redesignating subsections (j), (k), (l), and (n), as subsections (k), (m), (o), and (p), respectively; (10)by inserting after subsection (i) the following: (j)

Other labeling changes

If, on or after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, the Secretary determines that a pediatric study conducted under this section does or does not demonstrate that the drug that is the subject of the study is safe and effective, including whether such study results are inconclusive, in pediatric populations or subpopulations, the Secretary shall order the labeling of such product to include information about the results of the study and a statement of the Secretary’s determination. ; (11)in subsection (k), as redesignated by paragraph (9)— (A)in paragraph (1)— (i)by striking a summary of the medical and and inserting the medical, statistical, and; and (ii)by striking for the supplement and all that follows through the period and inserting under subsection (b) or (c).; (B)by redesignating paragraph (2) as paragraph (3); and (C)by inserting after paragraph (1) the following: (2)

Dissemination of information regarding labeling changes

Beginning on the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, the Secretary shall require that the sponsors of the studies that result in labeling changes that are reflected in the annual summary developed pursuant to subsection (f)(4)(F) distribute, at least annually (or more frequently if the Secretary determines that it would be beneficial to the public health), such information to physicians and other health care providers. ; (12)by inserting after subsection (k), as redesignated by paragraph (9), the following: (l)

Adverse event reporting

(1)

Reporting in year one

Beginning on the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, during the 1-year period beginning on the date a labeling change is made pursuant to subsection (i), the Secretary shall ensure that all adverse event reports that have been received for such drug (regardless of when such report was received) are referred to the Office of Pediatric Therapeutics established under section 6 of the Best Pharmaceuticals for Children Act (Public Law 107–109). In considering such reports, the Director of such Office shall provide for the review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such Committee regarding whether the Secretary should take action under this section in response to such reports. (2)

Reporting in subsequent years

Following the 1-year period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such Committee regarding whether the Secretary should take action in response to such reports. (3)

Effect

The requirements of this subsection shall supplement, not supplant, other review of such adverse event reports by the Secretary. ; (13)by inserting after subsection (m), as redesignated by paragraph (9), the following: (n)

Referral if pediatric studies not completed

(1)

In general

Beginning on the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, if pediatric studies of a drug have not been completed under subsection (d) and if the Secretary, through the committee established under subsection (f), determines that there is a continuing need for information relating to the use of the drug in the pediatric population (including neonates, as appropriate), the Secretary shall carry out the following: (A)For a drug for which a listed patent has not expired, make a determination regarding whether an assessment shall be required to be submitted under section 505B. Prior to making such determination, the Secretary may take not more than 60 days to certify whether the Foundation for the National Institutes of Health has sufficient funding at the time of such certification to initiate 1 or more of the pediatric studies of such drug referred to in the sentence preceding this paragraph and fund 1 or more of such studies in their entirety. Only if the Secretary makes such certification in the affirmative, the Secretary shall refer such pediatric study or studies to the Foundation for the National Institutes of Health for the conduct of such study or studies. (B)For a drug that has no listed patents or has 1 or more listed patents that have expired, determine whether there are funds available under section 736 to award a grant to conduct the requested studies pursuant to paragraph (2). (2)

Funding of studies

If, pursuant to paragraph (1), the Secretary determines that there are funds available under section 736 to award a grant to conduct the requested pediatric studies, then the Secretary shall issue a proposal to award a grant to conduct the requested studies. If the Secretary determines that funds are not available under section 736, the Secretary shall refer the drug for inclusion on the list established under section 409I of the Public Health Service Act for the conduct of studies. (3)

Public notice

The Secretary shall give the public notice of— (A)a decision under paragraph (1)(A) not to require an assessment under section 505B and the basis for such decision; (B)the name of any drug, its manufacturer, and the indications to be studied pursuant to a grant made under paragraph (2); and (C)any decision under paragraph (2) to refer a drug for inclusion on the list established under section 409I of the Public Health Service Act. (4)

Effect of subsection

Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of Title 18, United States Code. ; and (14)in subsection (p), as redesignated by paragraph (9)— (A)striking 6-month period and inserting 3-month or 6-month period; (B)by striking subsection (a) and inserting subsection (b); and (C)by striking 2007 both places it appears and inserting 2012. (b)

Effective date

Except as otherwise provided in the amendments made by subsection (a), such amendments shall apply to written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) made after the date of enactment of this Act.

3.

Program for pediatric studies of drugs

Section 409I of the Public Health Service Act (42 U.S.C. 284m) is amended— (1)by striking subsections (a) and (b) and inserting the following: (a)

List of priority issues in pediatric therapeutics

(1)

In general

Not later than 1 year after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and publish a priority list of needs in pediatric therapeutics, including drugs or indications that require study. The list shall be revised every 3 years. (2)

Consideration of available information

In developing and prioritizing the list under paragraph (1), the Secretary shall consider— (A)therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials; (B)particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and (C)the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators. (b)

Pediatric studies and research

The Secretary, acting through the National Institutes of Health, shall award funds to entities that have the expertise to conduct pediatric clinical trials or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups, federally funded programs such as pediatric pharmacology research units, other public or private institutions, or individuals) to enable the entities to conduct the drug studies or other research on the issues described in subsection (a). The Secretary may use contracts, grants, or other appropriate funding mechanisms to award funds under this subsection. ; (2)in subsection (c)— (A)in the heading, by striking contracts and inserting proposed pediatric study requests; (B)by striking paragraphs (4) and (12); (C)by redesignating paragraphs (1), (2), and (3), as paragraphs (2), (3), and (4); (D)by inserting before paragraph (2), as redesignated by subparagraph (C), the following: (1)

Submission of proposed pediatric study request

The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act, including with respect to the information provided on the pediatric studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric study request for a drug for which— (A)(i)there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act; or (ii)there is a submitted application that could be approved under the criteria of section 505(j) of the Federal Food, Drug, and Cosmetic Act; (B)there is no patent protection or market exclusivity protection for at least 1 form of the drug under the Federal Food, Drug, and Cosmetic Act; and (C)additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population. ; (E)in paragraph (2), as redesignated by subparagraph (C)— (i)by inserting based on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) after issue a written request; (ii)by striking in the list described in subsection (a)(1)(A) (except clause (iv)) and inserting under subsection (a); and (iii)by inserting and using appropriate formulations for each age group for which the study is requested before the period at the end; (F)in paragraph (3), as redesignated by subparagraph (C)— (i)in the heading, by striking contracts; (ii)by striking paragraph (1) and inserting paragraph (2); (iii)by striking or if a referral described in subsection (a)(1)(A)(iv) is made,; (iv)by striking for contract proposals and inserting for proposals; and (v)by inserting in accordance with subsection (b) before the period at the end; (G)in paragraph (4), as redesignated by subparagraph (C)— (i)by striking contract; and (ii)by striking paragraph (2) and inserting paragraph (3); (H)in paragraph (5)— (i)by striking the heading and inserting Contracts, grants, or other funding mechanisms; and (ii)by striking A contract and all that follows through is submitted and inserting A contract, grant, or other funding may be awarded under this section only if a proposal is submitted; (I)in paragraph (6)(A)— (i)by striking a contract awarded and inserting an award; and (ii)by inserting , including a written request if issued after with the study; and (3)by inserting after subsection (c) the following: (d)

Dissemination of pediatric information

Not later than 1 year after the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007, the Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of establishing a compilation of information on pediatric drug use and report the findings to Congress. (e)

Authorization of appropriations

(1)

In general

There are authorized to be appropriated to carry out this section— (A)$200,000,000 for fiscal year 2008; and (B)such sums as are necessary for each of the 4 succeeding fiscal years. (2)

Availability

Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended. .

4.

Reports and studies

(a)

GAO Report

Not later than January 31, 2011, the Comptroller General of the United States, in consultation with the Secretary of Health and Human Services, shall submit to Congress a report that addresses the effectiveness of section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) in ensuring that medicines used by children are tested and properly labeled, including— (1)the number and importance of drugs for children that are being tested as a result of the amendments made by this Act and the importance for children, health care providers, parents, and others of labeling changes made as a result of such testing; (2)the number and importance of drugs for children that are not being tested for their use notwithstanding the provisions of this Act and the amendments made by this Act, and possible reasons for the lack of testing, including whether the number of written requests declined by sponsors or holders of drugs subject to section 505A(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(g)(2)), has increased or decreased as a result of the amendments made by this Act; (3)the number of drugs for which testing is being done and labeling changes required, including the date labeling changes are made and which labeling changes required the use of the dispute resolution process established pursuant to the amendments made by this Act, together with a description of the outcomes of such process, including a description of the disputes and the recommendations of the Pediatric Advisory Committee; (4)any recommendations for modifications to the programs established under section 505A of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health Service Act that the Secretary determines to be appropriate, including a detailed rationale for each recommendation; and (5)(A)the efforts made by the Secretary to increase the number of studies conducted in the neonate population; and (B)the results of those efforts, including efforts made to encourage the conduct of appropriate studies in neonates by companies with products that have sufficient safety and other information to make the conduct of the studies ethical and safe. (b)

IOM study

Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine to conduct a study and report to Congress regarding the written requests made and the studies conducted pursuant to section 505A of the Federal Food, Drug, and Cosmetic Act. The Institute of Medicine may devise an appropriate mechanism to review a representative sample of requests made and studies conducted pursuant to such section in order to conduct such study. Such study shall— (1)review such representative written requests issued by the Secretary since 1997 under subsections (b) and (c) of such section 505A; (2)review and assess such representative pediatric studies conducted under such subsections (b) and (c) since 1997 and labeling changes made as a result of such studies; and (3)review the use of extrapolation for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment tools, and ethical issues in pediatric clinical trials.

5.

Training of pediatric pharmacologists

(a)

Investment in tomorrow's pediatric researchers

Section 452G(2) of the Public Health Service Act (42 U.S.C. 285g–10(2)) is amended by adding before the period at the end the following: , including pediatric pharmacological research. (b)

Pediatric research loan repayment program

Section 487F(a)(1) of the Public Health Service Act (42 U.S.C. 288–6(a)(1)) is amended by inserting including pediatric pharmacological research, after pediatric research,.

6.

Foundation for the National Institutes of Health

Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking and studies listed by the Secretary pursuant to section 409I(a)(1)(A) of the is Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(a)(d)(4)(C) and inserting and studies for which the Secretary issues a certification under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(n)(1)(A)).

7.

Continuation of operation of committee

Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by adding at the end the following: (d)

Continuation of operation of committee

Notwithstanding section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the advisory committee shall continue to operate during the 5-year period beginning on the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007. .

8.

Pediatric Subcommittee of the Oncologic Drugs Advisory Committee

Section 15 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended— (1)in subsection (a)— (A)in paragraph (1)— (i)in subparagraph (B), by striking and after the semicolon; (ii)in subparagraph (C), by striking the period at the end and inserting ; and; and (iii)by adding at the end the following: (D)provide recommendations to the internal review committee created under section 505A(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) regarding the implementation of amendments to sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a and 355c) with respect to the treatment of pediatric cancers. ; and (B)by adding at the end the following: (3)

Continuation of operation of subcommittee

Notwithstanding section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the Subcommittee shall continue to operate during the 5-year period beginning on the date of enactment of the Best Pharmaceuticals for Children Amendments of 2007. ; and (2)in subsection (d), by striking 2003 and inserting 2009.

9.

Effective date and limitation for rule relating to toll-free number for adverse events on labeling for human drug products

(a)

In general

Notwithstanding subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the Administrative Procedure Act) and any other provision of law, the proposed rule issued by the Commissioner of Food and Drugs entitled Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products, 69 Fed. Reg. 21778, (April 22, 2004) shall take effect on January 1, 2008, unless such Commissioner issues the final rule before such date. (b)

Limitation

The proposed rule that takes effect under subsection (a), or the final rule described under subsection (a), shall, notwithstanding section 17(a) of the Best Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not apply to a drug— (1)for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); (2)that is not described under section 503(b)(1) of such Act (21 U.S.C. 353(b)(1)); and (3)the packaging of which includes a toll-free number through which consumers can report complaints to the manufacturer or distributor of the drug.