The decision comes after Judge Edward Korman of the District Court of Eastern New York overturned Health and Human Services (HHS) Secretary Kathleen Sebelius’ ruling to put an age limit on obtaining Plan B without a prescription. In 2011, the Food and Drug Administration recommended that all women be allowed to access Plan B, a form of emergency contraception, without prescription. At the time, Plan B was available over-the-counter only to women aged 17 or older. But Sebelius overruled that proposal, and questioned the safety of having young girls taking the drug, which contains higher doses of the same synthetic hormone found in birth control pills, on their own.
Under the FDA’s new ruling, Plan B will now be available next to condoms and other reproductive health products, for girls to pick up off the shelves without engaging a pharmacist. The packaging will contain a code that alerts cashiers to ask for proof of age from anyone purchasing the drug.
Reproductive rights groups sued the government following Sebelius’ decision, which led to Judge Korman’s ruling on April 5 to make Plan B available over-the-counter without restrictions to all women. In making his argument, Judge Korman said Sebelius’ ruling was made in “bad faith and improper political influence,” writing in his decision, “it is hardly clear that the Secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable.” Korman gave the FDA 30 days to lift the current restrictions, but the FDA says the new approval was independent of the judge’s order, and resulted from an already pending application from Teva that requested its product be made available over-the-counter for women aged 15 or older. However, FDA Commissioner Dr. Margaret A. Hamburg briefed Sebelius about the review process and the amended Teva application, and Sebelius felt the new decision addressed her concerns, according to the HHS.
“Research has shown that access to emergency contraceptive products have the potential to further decrease the rate of unintended pregnancies in the United States. 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 Hamburg in a statement.
The FDA also filed an appeal to reverse Judge Korman’s ruling, and a spokesperson said the Department of Justice asked the court to prevent any changes in the current policy from taking effect during the appeals process.
In the meantime, the FDA’s ruling on Teva’s application is likely to fuel the debate over who should have access to Plan B. While advocates see greater access to emergency contraception as an important component in fighting teen pregnancy and enhancing women’s reproductive rights, others are concerned about the implications of putting important reproductive decisions in the hands of girls as young as 15. Below are some responses to the FDA’s approval.
On Tuesday, the FDA announced that the Plan B morning-after pill will move out from behind the counter and be available for girls ages 15 and older without a prescription.
Update: The story has been updated to reflect the FDA’s decision to appeal a court order requiring the agency to make Plan B available to all women without a prescription.
Dr. Jim Sears, board-certified pediatrician and co-host of The Doctors:
“While the numbers are improving, unplanned teen pregnancy remains a big concern in the U. S. The FDA’s new policy allowing teens as young as 15 to purchase the over-the-counter morning-after pill may have a significant impact on bringing those numbers even further down. I want to stress that simply because a drug is available over-the-counter, it does not necessarily mean that taking it is without risk. This is perfect opportunity for parents who may have avoided the topic to have a real discussion with their teens, both girls and boys, about the risks involved when it comes to sex. The morning-after pill should not be used as a primary method of contraception.”
Cecile Richards, President of Planned Parenthood Federation of America:
“While there are still practical questions to resolve, 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. Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within five days of unprotected sex.
“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. As the nation’s leading provider of women’s health care, Planned Parenthood knows firsthand how critical it is that women be able to get emergency contraception quickly and without hurdles.
Penny Nance, CEO and President of Concerned Women for America (CWA):
“It makes no sense that kids need parental permission to take aspirin at school, but they’re free to buy and administer Plan B. Also known as the morning-after pill, Plan B contains 40 times the dosage of Levonorgestrel, the same drug used in other forms of birth control. If Plan B is so ‘safe,’ then why is a prescription required for birth control? 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. If health officials continue to push women to make ‘Plan B’ their ‘Plan A,’ we have truly put politics and ‘progress’ ahead of the health of women and, now, our kids.”
Marcia D. Greenberger, Co-President of the National Women’s Law Center:
“While an improvement over current policy, today’s announcement is still disappointing because by retaining an age restriction that the FDA had previously determined was unnecessary, women of all ages must surmount barriers to getting the morning-after pill. Because all women will be required to show an ID to establish their age, those without IDs could be denied access. Further, there is no medical justification for young women under the age-cutoff to have to secure a prescription at all. As a court found recently, the Department of Health & Human Services had in an arbitrary way failed to follow FDA’s original determination and the merit of the ruling still stands.”
Jeanne Monahan, President of the March for Life Education and Defense Fund:
“The decision to make Plan B over-the-counter for girls aged 15 and 16 is not in the best interest of young women’s health. The decision will remove medical screening for adolescents who are sexually active and most people will agree that this defies common sense. Additionally, Plan B does nothing to help the spread of STDs, and studies show that it may in fact exacerbate this problem with young people. Young women deserve better.”
Nancy Northup, president and CEO of the Center for Reproductive Rights:
“The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday. Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women - but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend. These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women.”
Anna Higgins, Family Research Council’s Director of the Center for Human Dignity:
“This decision shows an alarming lack of concern for the safety of young girls, the fundamental rights of parents, and concerns of the medical community. The effects of taking a high dose of a systematically absorbed hormone during puberty are unknown. There have been no studies on the drug’s effect on young girls. OTC sales could encourage repeat use, which is unsafe.
“Over the counter availability of Plan B for teens distances those girls at highest risk for sexual abuse and sexually transmitted infections (STI’s) from the medical supervision they need. If Plan B is available OTC, teens and women will avoid necessary medical screenings during which serious medical problems like [sexually transmitted diseases] would be detected and treated. A 2010 study out of the UK shows that the increased availability of Plan B to teens was followed by a spike in STI rates among that age group.
“Additionally, this decision undermines the right of parents to make important health decisions for their young daughters. Parents have every right to be involved in any health decisions that affect their children. No parent wants his or her daughter exposed to a potentially dangerous medication without their consent. Instead of allowing unfettered access to potentially dangerous drugs to teens, parent-teen communication regarding the medical and moral issues involved with sexual behavior should be encouraged.”
U.S. Senator Patty Murray (Washington):
“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. It’s also a decision that moves us closer to these critical availability decisions being based on science, not politics. Plan B is an essential part of a woman’s basic health care and I will continue to push for more information from FDA and HHS on the practical application of this policy while also working to ensure that access is based on science, safety, and efficacy.”
Marjorie Dannenfelser, president of Susan B. Anthony List, A political action committee helping pro-life women gain election to Congress:
“The FDA is recklessly positioning itself as a parent to our children. Fifteen year old girls need the protection that comes with the involvement of real parents and doctors in their lives. Expanded access to potentially dangerous, abortion-inducing drugs does not strengthen children or families. We strongly urge the Obama Administration to stand by its 2011 position that requiring a prescription for these powerful drugs is common sense.”
By Alexandra Sifferlin