FDA approves 'morning-after pill' for women 15 and up

The Food and Drug Administration said Tuesday that the contraceptive known as Plan B should be available without a prescription for all women 15 and older.

The move is sure to stir controversy among social conservatives, some of whom view Plan B as a form of abortion. Unlike other forms of birth control, Plan B is intended for use after sex, rather than before.

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"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," the FDA said in a statement.

Until Tuesday, Plan B was only available over the counter to women 17 and older. The FDA had intended to make Plan B more widely available in 2011, but the agency was overruled by Health and Human Services Secretary Kathleen Sebelius.

Sebelius's move angered liberals, women's-health groups and the FDA's leadership. A federal judge strongly criticized the decision earlier this month, saying there was no scientific reason not to approve the drug for all women old enough to become pregnant.

Liberal lawmakers and stakeholder groups who slammed Sebelius' earlier decision praised the FDA on Tuesday.

“This decision is a step in the right direction for increased access to a product that is a safe and effective method of preventing unintended pregnancies," Sen. Patty Murray (D-Wash.) said. "It’s also a decision that moves us closer to these critical availability decisions being based on science, not politics."


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The Planned Parenthood Federation of America said the FDA should go further and eliminate all age restrictions on the drug — as the federal judge directed it to last month.

But lowering the age limit to 15 is a positive step, the group said.

"This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy," Planned Parenthood President Cecile Richards said in a statement.


The FDA said its decision to expand access to the drug was not motivated by the court's ruling, but simply a belated response to a request that the drug's manufacturer filed in 2011.

“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” FDA Commissioner Margaret Hamburg said. “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.”

Customers will have to prove they are 15 or older when they purchase the drug, the FDA said.

Updated at 6:04 p.m.