PlainBillCongress, translated.Legislation. Context. Public interest.Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S4695-4699)
Congressional Research Service
Version 00 · Introduced in Senate · Apr 18, 2007
Best Pharmaceuticals for Children Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make changes to provisions in regard to market exclusivity for pediatric drug studies on new drugs or already approved drugs, including to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than nine months prior to the expiration of such period.
Requires an applicant or holder who does not agree with a request to conduct pediatric studies to submit to the Secretary the reasons such pediatric formulation cannot be developed.
Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective that is not introduced onto the market within one year; and (2) create an internal review committee to review all written requests issued and all reports submitted.
Showing the opening paragraphs of the official summary.
Reduces market exclusivity for pediatric studies from six months to three months for drugs for which combined annual gross sales exceed $1 billion.
Requires the Secretary to order the labeling of a drug to include information about the result of a pediatric study whether such study does or does not demonstrate that the drug is safe and effective.
Requires the Comptroller General to submit a report to Congress that addresses the effectiveness of providing market exclusivity for pediatric studies in ensuring that medicines used by children are tested and properly labeled.
Includes pediatric pharmacological research within the pediatric research loan repayment program.
People & committees
Sen. Dodd, Christopher J. [D-CT] · D–CT
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S4695-4699)
Sponsor introductory remarks on measure. (CR S4694-4695)
Introduced in Senate
Primary sources
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Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.
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