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Pediatric Drug Development - Identifying the Needs, Meeting the Challenges
Monday, November 12
2:00 pm – 4:00 pm
Roundtable
ACPE #073-999-07-557-L04
Pediatric labeling for approved drug products has vastly improved over the last three years since the FDA has legislatively been empowered to act. New legislation enables the FDA to take either an incentive or enforcement approach to entice/mandate pharmaceutical companies to include age-specific labeling that includes dosing, pharmacokinetics, metabolism, precautions and side effects. The legislation applies to new or previously approved drug products. The incentive approach is presented in The Best Pharmaceuticals for Children Act (BPCA). Per the BPCA, a drug firm can obtain up to six months of market exclusivity provided the drug firm complies with requirements of a written request by the FDA for conducting clinical studies. The enforcement approach (Pediatric Research Equity Act) mandates a drug firm to conduct necessary clinical studies to support pediatric labeling. Although the marketplace has seen significant improvements in pediatric labeling, progress and innovation in pediatric formulations or drug delivery has not been keeping pace. Of the 114 drug products that have recently added pediatric labeling (see www.fda.gov/cder/pediatric/labelchange.asp), a pediatric-friendly drug delivery system does not exist for the majority. This could be due to waivers or deferrals granted by the FDA to drug firms showing scientific evidence of unusually difficult technical challenges when trying to formulate the drug substance into a pediatric formulation. In particular, innovation in pediatric drug delivery and pediatric friendly formulations is essential when trying to dose neonates, infants and children under the age of five. In order to conduct Phase I-III clinical studies in these age groups, there needs to be a reliable and accurate way to deliver the dose and assure compliance. The low return on investment has been a major deterrent in the past. However, the pediatric exclusivity legislation has improved the financial aspect. But there is more to be done to foster the cause of developing safe and efficacious pharmaceuticals for children. We must continuously be mindful of the differences between children and adults during the development process. In addition, we must also be mindful of cost considerations. To do this, we must be creative in our thinking and consider ways to streamline the development process without compromising the intermediate or final results. Following the adult drug development process verbatim would be too burdensome. We must adapt, modify or even totally change the operating paradigm. Progress has been made in identifying the needs of the pediatric population. Meeting these needs while realistically balancing against the financial aspects is the challenge. The roundtable will update the status of fulfilling the drug delivery needs of the pediatric population.
Moderators
Lorraine E. Pena, Ph.D.
Pharma Formulation Development, LLC
Joseph P. Reo, R.Ph., Ph.D.
Schering-Plough
The Pediatric Pharmaceutical and Clinical Trial Environment: Understanding and Removing the Barriers
Jon B. Bruss, M.D.
PediaMed Pharmaceuticals-The Pediatrics Company
Pediatric Formulation Strategies
Lorraine E. Pena, Ph.D.
Pharma Formulation Development, LLC