4. How does the provision in section 3 of the BPCA providing for a recommendation for a formulation change relate to the pediatric rule provision stating that in certain cases a sponsor may be required to develop a pediatric formulation? Should pediatric formulations be required in certain cases?
Yes. Lack of pediatric formulations renders some drugs impossible to administer despite efficacy in children. In my opinion, it is unethical to exclude children from the potential benefits of a drug that is otherwise approved for use and that has been demonstrated to be safe and effective in children.