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The Office of Pediatric Therapeutics (OPT) was established on October 1, 2002 in the Office of International Activities and Strategic Initiatives within the Office of the Commissioner. This office reports to Murray M. Lumpkin, M.D., Deputy Commissioner (Office of International and Special Programs). The Director of OPT is Dianne Murphy, MD, FAAP, and Robert “Skip” Nelson, MD, PhD is the bioethicist.
The creation of the office was mandated in section 6 of the Best Pharmaceuticals for Children Act (BPCA). The BPCA mandates that the office be staffed with one or more individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population and one or more individuals with expertise in pediatrics. The Pediatric Research Equity Act (PREA) mandated the formation of a Pediatric Advisory Committee (PAC), which is administered from OPT.
The Office of Pediatric Therapeutics is responsible for the coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues. OPT is currently responsible for pediatric ethical and safety issues, subpart D referrals from IRBs, pediatric trial oversight and coordination of all Pediatric Advisory Committee Activities. The two main area of focus for this office are safety and ethical issues that arise during the conduct of pediatric clinical trials or after a product has received pediatric exclusivity or has been approved for use in children. OPT is also to assist in coordinating pediatric issues across centers and with external groups and agencies.