In 2002, the U.S. Congress passed the Best Pharmaceuticals for Children Act that improved safety and efficacy of patented and off-patent medicines for children.

It continued the exclusivity provisions for pediatric drugs as mandated under the Food and Drug Administration (FDA) Modernization Act of 1997, in which market exclusivity of a drug is extended by six months, and in exchange the manufacturer conducted studies of the effects of drugs when taken by children.

The provisions both clarified aspects of the exclusivity period and amended procedures for generic drug approval in cases when pediatric guidelines are added to the labeling.