Pharmacy Administration, Policy and Regulation Commons^™

Does It Get Any Worse Than Acne? It Does, Actually. An In-Depth Review Of Accutane’S Regulatory History., Bridget A. Betts

Honors Theses

Isotretinoin, most often recognized by the brand name Accutane®, is regarded by many patients and prescribers as the miracle cure for acne. Its unsurpassed efficacy is paired with serious risk of adverse events and birth defects, which poses ethical questions regarding its safety and necessity. Its regulatory history established precedent in Food and Drug Administration Risk Evaluation and Mitigation Strategies and brought awareness to the sharp dangers of teratogenic drug use.

This medication came as a breakthrough solution to patients that suffered years of unsuccessful regimens for the treatment of acne vulgaris. Some question the risk-benefit evaluation of such a …