2002 Best Pharmaceuticals for Childrens Act
In January of 2002, Congress passed the Best Pharmaceuticals for Children Act (BPCA), which was its second major attempt to increase the number of clinical tests performed on pediatric populations. Congress passed the BPCA in response to the modest success of its earlier effort to promote pediatric clinical testing, the pediatric exclusivity provision of the Food and Drug Administration Modernization Act of 1997 (FDAMA). With both the 1997 and 2002 efforts, Congress has attempted to address the dearth of information about the safety and effectiveness of drugs that children commonly use.
Before the passage of the FDAMA, few drugs were labeled for children, as neither Congress nor the Food and Drug Administration required pediatric testing of drugs, and drug companies rarely labeled drugs for children on their own. A 1994 study found that six of the ten drugs most commonly prescribed to children had no pediatric labeling.
The BPCA does not require pediatric testing, but it does establish a two-tiered approach to ensure research of drugs used by pediatric populations. Under this approach, a manufacturer may opt to test its own drug in pediatric clinical trials and thereby earn an additional six-month term to its patent. If a manufacturer does not wish to perform such pediatric studies, the BPCA allots funds to enable the FDA to contract for the testing of those drugs for which it believes pediatric studies would be beneficial.
- Food and Drug Administration, Legislation, http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
- Food and Drug Administration, History, http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm