Published Date: 01/07/2015
Category: Drug Delivery & Devices
Off-label drug use in pediatrics is high, occurring in up to XX% of children on pediatric wards and closer to XX% of children in intensive care. A lack of evidence-based prescription data and appropriate formulations can lead to ineffective dosing and an increased risk of adverse effects and is an area of high unmet clinical need, having yet to be fully addressed by the industry and regulators. In 2013, global revenue from pediatric medicines represented about XX% of total pharma sales, generating nearly $XXbn. Innovation has been dampened by the complex regulatory processes, high generic drug use (low drug prices) and low medical need to treat chronic illnesses. Regulators need to convince the industry to prioritize areas of unmet clinical need, streamline and align the regulatory process, and offer appropriate incentives to encourage further industry investment. Pharma companies face significant ethical, logistical and formulation challenges during the development of pediatric medicine. Trial sponsors need to liaise with the regulators earlier in the development process, to avoid unnecessary regulatory delays.