Drug safety questions in the US pharmaceutical industry1 have forced the Food and Drug Administration (FDA) to add isotretinoin to a mandatory risk management program and registry to minimize fetal exposure.2 Justifiable regulations to minimize the teratogenic risk have been proposed in the iPledge program3 administered by Covance and the isotretinoin manufacturers. The American Academy of Dermatology4 has stated that the iPledge program is seriously flawed for real world application. An iPledge program needs to be developed that allows an efficient, economical solution for patient, physician, laboratory, and pharmacy participation without obtrusive, time consuming paperwork and administrative regulation.
Brown AC. The Smart CardAn Alternative Solution for the iPledge Program. Arch Dermatol. 2006;142(8):1055-1057. doi:10.1001/archderm.142.8.1055