S. 1789 · 107th Congress · enacted
Best Pharmaceuticals for Children Act
Became Public Law No: 107-109.
Latest official action 2002-01-04 · Enacted
The bill, briefly
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. Includes within the purposes and activities of the Foundation for the National Institutes of Health the collection of funds for pediatric …
Congressional Research Service · 2001-12-07
Who reported lobbying on this bill?
Amount spent specifically on this bill: not disclosed
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Politicians behind the bill
Sponsors and cosponsors from the official source, limited to members currently in office. Campaign amounts are cycle-wide and are not payments for this bill.
No current-officeholder sponsorship match is available. Historical sponsors may have left office.
1 of 1 source cosponsor records retrieved; only current officials and unwithdrawn sponsorships appear.
PAC donors to the listed sponsors
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What happened after enactment?
Dated agency-reported implementation and uptake measures are shown with their scope. They do not by themselves establish causal success. If no evidence is listed, the outcome is not established.
Measured outcome: not established
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