The Physicians' Labeling Rule: An Evaluation of Compliance

The primary purpose of this study was to evaluate compliance of newly approved labeling with the Physicians' Labeling Rule (PLR). Labeling (prescribing information) for 221 products in PLR format approved during the first 30 months following the regulation effective date were compared with requirements set by the PLR regulation, as well as with available FDA guidances and prespecified best practices. Although compliance with regulation and guidances was more than or equal to 95% for 54% of all parameters examined, there were several areas for improvement. Deviations from guidances were more likely than deviations from regulation, and the majority were related to content and redundancy issues rather than formatting. An evaluation of deviations by date of approval revealed a trend for an increasing number of deviations over time. Continued evaluation of compliance will be important to ensure that prescribing information remains in compliance with the PLR regulations.