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  1. 1
    Peer Reviewed

    Contemporary issues in women's health.

    Arulkumaran S; Johnson TR

    International Journal of Gynecology and Obstetrics. 2004 Nov; 87(2):111-113.

    In May 2004, the Food and Drug Administration of the United States ruled that emergency contraception would not be available over the counter. In December 2003, two FDA expert panels overwhelmingly recommended approval of the drug by a 23 to 4 vote after reviewing more than 15,000 pages of data for over 40 studies in support of the over the counter (OTC) application. The FDA typically follows the recommendations of the government scientific committees, and the experts in this case made it clear that use of emergency contraception does not increase promiscuity or unprotected sex among teenaged women. In an unusual decision written by Dr. Steven Galson, Acting Director of FDA’s Center for Drug Evaluation and Research, and not supported by other members of the FDA staff, a decision was deferred pending further information about the safety of emergency contraception in girls under the age of 16 or on the possibility raised by the manufacturer in their proposal that the drug be used over the counter for girls over the age of 16 and that there be an age limit to those who could get it without speaking to a pharmacist or without a prescription. (excerpt)
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