Comments on: Are food and drug administration prescription drug safety plans working? A case study of isotretinoin

摘要

Fain and Alexander commented on the database study by Pinheiro et al. that evaluated the effectiveness of iPledge, the Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, noting several limitations to the approach used. They also suggested that survey-based analyses are "fraught with methodological challenges." Although their latter point may be true for some surveys, we believe that it is feasible to design and perform scientifically rigorous surveys to evaluate REMS. Indeed, from 1989 to 2003, the Slone Epidemiology Center conducted the Accutane Survey, an independent evaluation of the Pregnancy Prevention Program for Accutane (the first risk management program directed at pregnancy prevention), which was initiated in 1988. In our 1995 report in the New England Journal of Medicine on over 177000 women (and in subsequent reports to the Food and Drug Administration on over 492 000 women) who were followed during their isotretinoin treatment and for 6 months thereafter, we provided the distribution of the contraceptive methods reported by women in the Survey.