H.R. 2589 · 110th Congress
Improving Pharmaceuticals for Children Act of 2007
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Never voted on. It didn't reach a floor vote before the 110th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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EshooSponsorNo cosponsors.
Improving Pharmaceuticals for Children Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions relating to market exclusivity for pediatric drug studies on new or already approved drugs to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the…
What it does: CRS summary · Introduced in House · Jun 6, 2007
Improving Pharmaceuticals for Children Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions relating to market exclusivity for pediatric drug studies on new or already approved drugs 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 one year prior to the expiration of such period.
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 in the pediatric population if such formulation is not introduced onto the market within one year; and (2) order the labeling of a drug to include information about the results of a pediatric study.
Requires the Secretary, acting through the Director of the National Institutes of Heath (NIH), to develop, publish, and revise a priority list of needs in pediatric therapeutics.
Revises requirements for the submission of pediatric assessments of the safety and effectiveness of a drug or biological product with a new drug or supplemental application to require an applicant seeking: (1) a deferral of such requirements to submit a timeline for the completion of such studies; and (2) a waiver of such requirements to submit documentation detailing why a pediatric formulation cannot be developed.
Considers a supplement to any new drug or biological license application proposing a labeling change as a result of any pediatric assessment to be a priority application or supplement.
Requires the Comptroller General to study the effectiveness of federal law in ensuring that medicines used by children are tested and properly labeled.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Improving Pharmaceuticals for Children Act of 2007
Latest action (Jun 6, 2007): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jun 6, 2007
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.