The valuable commentary by Drs. Phelps and Kelver on potential liability issues for physicians prescribing the Ortho-Evra (norelgestr&min/ethinyl estradiol [E2]), Ortho Women's Health & Urology, Raritan, NJ) contraceptive patch1 provides a much-needed start, but only one perspective, on this important and ongoing clinical practice issue. As a food and drug law attorney as well as a former Senior Medical Officer in the Division at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), which handled the original approval of the contraceptive patch as well the ensuing controversy, I would like to provide additional information and a different perspective.
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