The Food and Drug Administration said Tuesday it has approved selling a version of the morning-after contraceptive pill without a prescription to girls 15 years of age or older — down from the current 17-year-old age limit.
This pill, Plan B One-Step, is one of three emergency contraceptives available. The other two are still subject to more stringent restrictions on purchases.
“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,” said Dr. Margaret A. Hamburg, the FDA’s commissioner.
The agency had earlier denied Teva’s application to make Plan B One-Step available over the counter to all females, and imposed the 17-year cut-off. Teva filed an amended proposal asking for the 15-year cutoff.
FDA officials said the move had nothing to do with an ongoing case involving another emergency contraceptive, Plan B, which is a two-dose drug.
Earlier this month, a federal judge in New York rebuked Health and Human Services Secretary Kathleen Sebelius for making an “obviously political” decision in 2011 — one year before President Obama’s re-election — to prohibit the sale of Plan B One-Step and its generic forms to girls younger than 17 unless they had a prescription.
He ordered the FDA to grant a citizens’ petition to make the drug available without point-of-sale or age restrictions within 30 days.
Agency officials have not signaled how they intend to comply with, or challenge, the order.
Pro-life organizations have railed against the Obama administration for requiring faith-based nonprofits and corporations with religiously devout owners to insure contraception — including morning-after pills — under the Affordable Care Act. Dozens of lawsuits have been filed to contest the mandate, which may be headed for the Supreme Court.
Yet Judge Edward Korman’s decision to broaden teen girls’ access to emergency contraception found pro-life groups aligned with the White House — at least for a moment.
Conservative lawmakers and advocates have equated morning-after pills such as Plan B and Ella, the third emergency contraceptive, with abortion, although the FDA rejected that view in its statement Tuesday.
“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 agency said.
Planned Parenthood Federation of American applauded the FDA’s move as an “important step forward,” yet signaled it would like to see all age restrictions lifted.
“While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine,” Planned Parenthood President Cecile Richards said.