Business and Economics

FDA Approves Over-counter Emergency Contraception Pill

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The U.S. Food and Drug Administration says it has approved a request by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older. Planned Parenthood of Indiana calls the decision an “important step forward.”

Planned Parenthood of Indiana President and CEO Betty Cockrum says her organization supports the decision by the Department of Health and Human Services, as parent department of the FDA. “Making emergency contraception more accessible is an important step forward in reproductive health care policy,” Cockrum said. “Ideally, young women and men are well-informed about and prepared for the consequences of becoming sexually active. But, as we know, life isn’t always ideal.”

The FDA says Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse, taken as a single-dose pill (1.5 mg tablet) most effective if taken immediately or within 3 days after unprotected sex. It says, “Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus.”

Planned Parenthood of Indiana says, “EC (emergency contraception) is effective for up to 120 hours after intercourse, with its effectiveness diminishing with time. As many as 11 percent of women who have been sexually active have used EC, according to a recent report from the National Center on Health Statistics.”

The FDA says that after it did not approve Teva’s application to make Plan B One-Step available over-the-counter for all females of reproductive age in 2011, the company submitted an amended application to make the product available for women 15 years of age and older without a prescription.

FDA Commissioner Margaret Hamburg, M.D., says, “Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States. The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”

The agency says two other emergency contraceptive drugs besides Plan B One-Step are marketed in the United States: Plan B and ella. Plan B is available from generic manufacturers and requires a prescription for women under the age of 17, and Ella (ulipristal) is a prescription-only product to prevent pregnancy when taken within 120 hours (five days) after unprotected sexual intercourse. The approval of Teva’s application for Plan B One-Step does not affect the prescription status of these other drugs.

Teva Women’s Health is based in North Wales, Pa.

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