FDA Approves Prescription-Free ‘Morning-After Pill’ for Ages 15 and Up
The FDA has approved the sale of Plan B One-Step pills, a type of ‘morning-after pill’ manufactured by Teva Women’s Health Inc., for girls ages 15 and older without a prescription. The contraceptive pills will now be available on store shelves instead of behind pharmacy counters, as was previously the case.
The government’s decision is independent of a federal judge’s recent ruling that ordered the FDA to ensure availability of ‘morning-after pills’ to all women and girls of reproductive age.
“The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling,” FDA officials said in a statement.
Under the new FDA rules, Plan B will be labeled as not for sale to girls under age 15, and those wishing to purchase the pills will be required to show identification proving they are at least 15. Teva has also agreed to fix security tags to packages of the drug to guard against theft.
In approving Teva’s application to lower the Plan B age limit to 15, FDA Commissioner Margaret Hamburg cited research showing that access to emergency contraception could reduce the rate of unintended pregnancies among young women.
In the separate court case involving access to emergency contraception, US District Judge Edward Korman ruled last month to reverse a December 2011 decision by US Health and Human Services Secretary Kathleen Sebelius to reject an FDA move to allow girls as young as 17 to purchase emergency contraception pills without a prescription. President Barack Obama backed Sebelius’ move, citing his two daughters and drawing criticism that he was pandering to socially conservative voters ahead of last year’s election.
“I will say this, as the father of two daughters: 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.
Judge Korman called Sebelius’ decision “arbitrary, capricious and unreasonable.”
“The motivation for the secretary’s action was obviously political,” the judge wrote in his ruling.
The women’s sexual and reproductive health services provider Planned Parenthood– which performs hundreds of thousands of abortions annually– called the FDA decision “an important step forward.”
“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 said in a statement.
Anti-abortion advocates slammed the FDA decision to make Plan B available to 15-year-olds without a prescription. Despite an FDA statement assuring that the pill “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,” Anna Higgins of the Center for Human Dignity (part of the Family Research Council, an SPLC-designated hate group) said the ruling “places the health of young girls at risk.” Higgins told LifeNews that “making Plan B over-the-counter for any age will put many… young girls at further risk” of contracting sexually-transmitted diseases and that there’s a “real danger” the pill would be “given to young girls under coercion or without consent.” Higgins offered no evidence to support this claim.
Tagged Anna Higgins, Center for Human Dignity, emergency contraception, FDA lowers age for morning-after pills to 15, Food and Drug Administration, Judge Edward Korman, kathleen sebelius, Kathleen Sebelius morning-after pill, Margaret Hamburg, morning-after pill, morning-after pill age limit, obama contraception, Obama morning-after pill, Plan B One-Step, Planned Parenthood contraception, Teva Women's Health, unintended pregnancies