Best Pharmaceuticals for Children Act

Summary

Best Pharmaceuticals for Children Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services, through the National Institutes of Health, to develop an annual list of approved drugs for which: (1) there is an approved or pending new drug application or no patent or market exclusivity protection; and (2) additional pediatric safety and effectiveness studies are needed. Directs the Secretary to award contracts to entities with appropriate experience for pediatric clinical trials of such drugs. Establishes a Food and Drug Administration (FDA) contract process for related labeling changes. Amends the Federal Food, Drug, and Cosmetic Act to: (1) eliminate the user fee waiver for pediatric supplements to a human drug application; (2) provide priority status for pediatric supplements; (3) include neonates within the definition of pediatric studies; (4) provide for dissemination of pediatric supplement information; and (5) set forth requirements for the additional six-month exclusivity period for new or already-marketed pediatric drugs. Directs the Secretary to establish an Office of Pediatric Therapeutics within the Office of the Commissioner of Food and Drugs, which shall coordinate all FDA pediatric activities. Amends Title IV of the Public Health Service Act to direct the Secretary to establish the Foundation for Pediatric Research to support research on drugs lacking exclusivity for which pediatric studies are needed. Directs the Secretary to contract with the Institute of Medicine to review Federal regulations, reports, and support for research involving children, with particular attention to issues of compensation, informed consent, and risk/ benefits assessments in terms of research versus therapeutic treatment.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

11 official files

• Placed on Calendar Senate (text)

  Placed on Calendar Senate · EN · 16 November 2001

  ViewDownloadOpen at official source

• Placed on Calendar Senate (PDF)

  Placed on Calendar Senate · EN · 16 November 2001

  ViewDownloadOpen at official source

• Engrossed in House (text)

  Engrossed in House · EN · 15 November 2001

  ViewDownloadOpen at official source

• Engrossed in House (PDF)

  Engrossed in House · EN · 15 November 2001

  ViewDownloadOpen at official source

• Passed House amended

  summary · EN · 15 November 2001

  Open at official source

• Reported in House (text)

  Reported in House · EN · 9 November 2001

  ViewDownloadOpen at official source

• Reported in House (PDF)

  Reported in House · EN · 9 November 2001

  ViewDownloadOpen at official source

• Reported to House with amendment(s)

  summary · EN · 9 November 2001

  Open at official source

• Introduced in House (text)

  Introduced in House · EN · 13 September 2001

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 13 September 2001

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 13 September 2001

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.