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FDA Approves 'Plan B' Pill for 17-Year-Olds

Decision is latest involving controversial birth-control drug

By Amanda Gardner
HealthDay Reporter


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WEDNESDAY, April 22 (HealthDay News) -- Responding to a federal judge's directive, the U.S. Food and Drug Administration said Wednesday that it will now allow 17-year-olds to get the controversial "morning-after" birth control pill without a doctor's prescription.

In 2006, the FDA said it would limit over-the-counter access to the pill, also known as Plan B, to women 18 and older. But U.S. District Judge Edward R. Korman ruled last month in a New York lawsuit that the FDA had to reconsider whether to make the drug available to all women, regardless of age, without a prescription. He ordered the agency to let 17-year-olds get the drug, and separately to evaluate whether all age restrictions should be lifted.

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"On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription," the agency said in a statement issued Wednesday afternoon on its Web site. "The government will not appeal this decision. In accordance with the court's order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."

Plan B is an extra high dose of regular birth control that needs to be taken within 72 hours of unprotected intercourse to be effective. Essentially, the drug prevents pregnancy by delaying ovulation. It does not interrupt an already implanted pregnancy.

Religious conservatives object to Plan B, saying it is the equivalent of an abortion pill because it can prevent a fertilized egg from attaching to the uterus, and could also encourage premarital sex.

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Copyright © 2006 ScoutNews, LLC. All rights reserved.
Last updated 4/23/2009

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SOURCES: April 22, 2009, news release, U.S. Food and Drug Administration; Aug. 24, 2006, news conference with Steven Galson, M.D., director, U.S. Food and Drug Administration Center for Drug Evaluation and Research


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