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NORTH WALES, Pa. — Teva earlier this week announced it had submitted a request to the Food and Drug Administration to allow for the sale of the emergency contraceptive Plan B One-Step to women under the age of 17 years without a prescription, according to published reports.
The switch of Plan B from prescription-only to a de facto behind-the-counter status marked a tumultuous debate for the FDA under the Bush administration. Consequently, many advocates are gearing for another political battle. Many women’s groups seek wider access, while conservative groups would like to greatly limit access altogether because they believe Plan B is an abortion alternative.
According to reports, Teva gave the FDA additional data based on a study of actual use of the contraceptive in girls between the ages of 11 years and 16 years. It expects the agency to rule within 10 months.