S. 993 · 110th Congress
Pediatric Research Improvement Act
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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.
D
ClintonSponsor1 cosponsor · 1 D
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Pediatric Research Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct an applicant seeking to waive submission requirements related to pediatric assessments of the safety and effectiveness of a drug or biological product to submit to the Secretary of Health and Human Services documentation detailing why a pediatric…
What it does: CRS summary · Introduced in Senate · Mar 27, 2007
Pediatric Research Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct an applicant seeking to waive submission requirements related to pediatric assessments of the safety and effectiveness of a drug or biological product to submit to the Secretary of Health and Human Services documentation detailing why a pediatric formulation cannot be developed.
Requires an applicant seeking to defer submission of some or all of such assessments to submit to the Secretary a timeline for the completion of pediatric studies.
Requires the Secretary to create an internal committee to review pediatric assessment requests issued, pediatric assessments conducted, and deferral and waiver requests.
Considers a supplement to a new drug or biological license application proposing a labeling change as a result of any pediatric assessments to be a priority supplement. Sets forth dispute resolution procedures for labeling changes for pediatric drugs.
Requires the Commissioner of the Food and Drug Administration (FDA) to make available to the public the medical, statistical, and clinical pharmacology reviews of pediatric assessments.
Requires the Secretary to: (1) require sponsors of the assessments that result in labeling changes to distribute such information to physicians and other health care providers; (2) ensure that all adverse event reports that have been received for such a drug are referred to the Office of Pediatric Therapeutics for one year after a labeling change; and (3) contract with the Institute of Medicine to study and report to Congress regarding the pediatric studies conducted pursuant to FFDCA since 1997.
Requires the Comptroller General to report to Congress on the effectiveness of FFDCA provisions relating to pediatric studies 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: Pediatric Research Improvement Act
Latest action (Mar 27, 2007): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Mar 27, 2007
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.