OFFICE OF NEW DRUGS MODULE

Off-Patent Drugs

BPCA establishes a process to study off-patent drugs as well. A priority list of pediatric therapeutic needs - including drugs or indications that require study - is developed by NIH in conjunction with experts around the country.

NIH may submit a proposed pediatric study request to FDA, or FDA may issue a written request. The written request is issued to the sponsors marketing the drug product. The sponsors have 30 days to respond to the study request.

If the company declines to conduct studies, FDA refers the drug and the written request to the National Institute of Child Health and Human Development (NICHD) which can publish a request for proposals to conduct the studies.