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Wednesday
Dec072011

Plan B: 'Morning After Pill' Blocked from Hitting Drug Store Shelves

Joe Raedle/Getty Images(WASHINGTON) -- U.S. Department of Health and Human Services Secretary Kathleen Sebelius has blocked the Plan B "morning after" birth control pill from hitting drug store shelves, countering recommendations from the U.S. Food and Drug Administration.

"Today's action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional," Sebelius wrote in a statement.

FDA Commission Dr. Margaret Hamburg said in a statement that she believes there is adequate and well-supported data that shows Plan B One-Step is safe and effective for nonprescription use for all females of childbearing years -- an opinion vetoed by Sebelius.

"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women's Health, Inc.," Sebelius wrote.

The move would have landed the emergency contraceptive on drugstore shelves alongside condoms, spermicides and contraceptive sponges. Instead, women 17 and older can continue to buy the high-dose hormone pill over the counter, but girls younger than 17 still need a prescription.

Teva Pharmaceutical Industries Ltd., the maker of Plan B One-Step, requested the switch in February.

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of the uterus if taken within 72 hours of unprotected sex. The drug is not effective if the woman is already pregnant, and it reportedly does not pose harm to a fetus.

In 2008 the FDA ruled that women 18 and older could buy Plan B over the counter. A year later, the agency expanded the regulation to include those 17 and older.

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