FDA Approves Application for Plan B Pill for Women as Young as 15
The Food and Drug Administration announced its approval of making Plan B or the "morning after" pill available for women as young as 15 years of age without a prescription.
FDA Commissioner Dr. Margaret A. Hamburg said in a statement Tuesday that the FDA approved an amended application by Teva Women's Health, Inc. to begin marketing Plan B to women 15 and older sans a prescription.
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," said Hamburg.
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"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."
Last month, U.S. District Judge Edward Korman for the Eastern District of New York ruled that the U.S. Food and Drug Administration should allow women of any age to buy emergency contraception without a prescription.
"The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable," wrote Korman in his order to the FDA.
Korman's decision went against the position of both social conservative groups and the Obama administration.
For his part, President Barack Obama endorsed the Department of Health and Human Services' policy that blocked over-the-counter sales of emergency contraception to women under the age of 17. This stated position by HHS came in response to an application submitted by Teva Women's Health, Inc. in February 2011.
"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," said HHS Secretary Kathleen Sebelius in a statement in December 2011.
"I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age."
Penny Nance, CEO and President of Concerned Women for America, said in a statement that the FDA decision and the Korman order encourage harmful behavior among women.
"The same 'women's rights' advocates who want every decision to be between 'a woman and her doctor' are now eliminating the doctor, isolating young girls in situations that need adult guidance," said Nance.
"In fact, studies show that morning-after pills increase rates of unintended pregnancy and abortion. In Great Britain and Sweden, where they have studied the effects of giving Plan B to kids, they concluded that it increased pregnancy and STDs, because it gave the girls a false sense of security and, I would say, permission to make a wrong choice."
