Best Pharmaceuticals for Children Act
Latest action · Dec 28, 2001 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedDec 11, 2001
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Includes within the purposes and activities of the Foundation for the National Institutes of Health the collection of funds for pediatric pharmacological research.
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.
Cosponsors 1
Members who signed on, in the order they did. All signed on Dec 11, 2001.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CA | Anna G. Eshoo | Original | Dec 11, 2001 |
Actions 3
Everything that happened, newest first.
- Dec 28, 2001Referred to the Subcommittee on Health.
- Dec 11, 2001Introduced in House
- Dec 11, 2001Referred to the House Committee on Energy and Commerce.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 1789 | Best Pharmaceuticals for Children Act | Identical bill | Jan 4, 2002 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative procedure
- Administrative remedies
- Bioethics
- Cancer
- Chemotherapy
- Child health
- Clinical trials
- Commerce
- Congress
- Congressional investigations
- Congressional reporting requirements
- Cost effectiveness
- Department of Health and Human Services
- Drug adulteration
- Drug approvals
- Drug industry
- Drug interactions
- Drug therapy
- Drug utilization
- Economic impact statements
- Economics and Public Finance
- Executive reorganization
- Families
- Federal advisory bodies
- Federal aid to medical research
- Finance and Financial Sector
- Generic drugs
- Government Operations and Politics
- Government paperwork
- Government publicity
- Governmental investigations
- Health
- Health insurance
- Health insurance industry
- Hospital care
- Human experimentation in medicine
- Infants
- Informed consent (Medical law)
- Insurance premiums
- Intellectual property
- Labeling
- Law
- Medicaid
- Medical economics
- Medical ethics
- Medical research
- Minorities
- Minority health
- Parent and child
- Patents
- Pharmaceutical research
- Pharmacists
- Research grants
- Science, Technology, Communications
- Social Welfare
- Telephone
- User charges
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.