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Executive Summary

ORAL CONTRACEPTIVE LABELING CHANGE MODIFYING PHYSICAL EXAM REQUIREMENT will be implemented by manufacturers with the next printing of labeling. Changes will be made to physician prescribing information and patient package inserts to indicate that the physical exam, previously required in labeling prior to oral contraceptive use, may be postponed at the patient's request if the physician deems it appropriate. The amended labeling will instruct prescribers that while "it is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives," the physical exam "may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician." Current language in the precautions section of labeling states: "A complete medical history and physical examination should be taken prior to the initiation or reinstitution of oral contraceptives and at least annually during use of oral contraceptives." The brief summary patient package insert and the "other information" section of the detailed PPI will also be changed. Current labeling states: "Your health care provider will take a medical and family history before prescribing oral contraceptives and will examine you," will be followed by a new sentence: "The physical examination may be delayed to another time if you request it and the health care provider believes that it is good medical practice to postpone it." The labeling change was requested by the Planned Parenthood Federation of America out of concern that fear of pelvic exams or scheduling problems might deter women from using OCs. On May 20, FDA's Fertility & Maternal Health Advisory Committee reviewed the proposal and voted nine to one in favor of it ("The Pink Sheet" May 24, T&G-2). FDA approved the changes June 28 and issued a letter to OC manufacturers instructing them to "incorporate the changes... in your labeling as reflected by your most recently approved labeling combined with any additional labeling changes requested by the agency (to be submitted as 'special Supplements')." Any modification to the new language will require prior approval before they can be implemented.

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