government

HHS keeps emergency contraception behind the counter

NEWS IN BRIEF — Posted Dec. 19, 2011

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Health and Human Services Secretary Kathleen Sebelius overruled a Food and Drug Administration recommendation that would have allowed the contraceptive drug known as the "morning-after pill" to be sold on drug store shelves.

"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 drug application by Teva Women's Health, Inc.," Sebelius said in her Dec. 7 decision. Sebelius later indicated that Teva could reapply and submit additional data.

Teva Women's Health had applied to eliminate prescription dispensing requirements for the contraceptive, which can prevent pregnancy if taken within 72 hours of sexual intercourse. Plan B One-Step is sold behind the counter in pharmacies, but women ages 17 and older who show identification can purchase the drug without a prescription.

A Teva Women's Health spokesperson did not respond to a request for comment by this article's deadline. Women's health groups and some Democratic lawmakers reacted negatively to the decision, saying the FDA recommendation should have been followed.

President Obama said during a Dec. 8 briefing with reporters that he did not get involved in Sebelius' decision but that he supported it.

"I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine," Obama said. "And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going to a drugstore should be able -- alongside bubble gum or batteries -- be able to buy a medication that potentially, if not used properly, could end up having an adverse effect."

The drug has been deemed to be safe by the FDA and still will be available to women 17 and older without a prescription, he noted.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2011/12/19/gvbf1219.htm.

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