OFFICE OF NEW DRUGS MODULE

Best Pharmaceuticals for Children Act (BPCA)

Essentially, BPCA:

• Provides for voluntary pediatric drug assessments via a written request, including clinical and non-clinical studies.
• Authorizes FDA to request studies of approved and/or unapproved pediatric indications. For example, if valproic acid or divalproex sodium is submitted for a new approval to treat seizures in adults, the PREA requirement would be to submit for a new approval to treat seizures in children or the same indication. However, under BPCA, FDA can request studies for migraine, migraine prophylaxis, and for the treatment of mania since the drug also treats those indications.
• Reflects a public health need for pediatric studies. If a company has a product that is being used off-label in the pediatric population, FDA can require studies of that usage.
• May include on- and off-label indications.
• Establishes the requirement that an internal committee review all written requests prior to their issuance.