The Food and Drug Administration will make the most widely known morning-after pill available on drugstore shelves to women ages 15 and older.
The pill, Plan B One-Step, was previously only available to women ages 17 and older, and it was only available behind the counter.
The decision comes after years of court battles between National Women’s Liberation and the U.S. government to make the drug available to all women.
Candi Churchill, National Women’s Liberation member in the Gainesville chapter and plaintiff in the current federal lawsuit against the Obama administration, said the decision to continue to place any age restriction on the drug is an insult. She said the government is ignoring the recommendations of the FDA, who approved the drug for women of all ages in 2011.
“We are actually very disappointed in the government,” said Churchill, who testified in 2004 to the FDA, when the pill was prescription-only. “They are continuing to keep it out of the hands of millions of women by requiring an ID and an age restriction.”
Churchill said the National Women’s Liberation believes the government is in defiance of a court order established in early April by U.S. District Court Judge Edward Korman, who ordered the FDA to make the pill available to all women over the counter. She said the U.S. government must comply by May 6.
“National Women’s Liberation believes that any female old enough to get pregnant is old enough to decide if she doesn’t want to be, and it should be completely over the counter, like gum and condoms,” she said.
Churchill said when she testified in 2004, it was regarding her own experiences with using the pill and trying to get it when it was prescription-only.
“When it required a prescription, you had to go to a doctor, get a doctor’s appointment, pay for a doctor’s appointment and then go to a pharmacist, and sometimes the pharmacist would give you grief about this perfectly safe form of birth control,” she said.
Churchill said in comparison, there are 63 other countries that have no age restrictions on the pill without a prescription.
“We testified about the hoops you have to jump through as a young woman trying to control her life, ” she said. “I testified, personally, about using it and it being really not a big deal. It helped me be able to back up condoms, or just be able to have that relief.”
Churchill said she does not know why there are still age restrictions to the pill in the U.S.
“The United States has one of the highest teen pregnancy rates in the industrialized world, according to the United Nations,” she said. “We have some of the highest unintended pregnancies. Why our government would stand in the way of a simple, preventative medication to control our fertility is beyond me. I think our government needs to get out of the way, and put science and health tools directly in the hands of the women who need them.”
She said her organization will continue to petition and organize, as well as look into legal options if the government continues to defy the court order.
Rachel Burgin, executive director of Florida Right to Life, said her organization feels that the FDA was rushed into making a decision and pushed into a corner by the judge who mandated the pill be available to everyone.
Burgin said the reason they are not pleased about it being available to 15-year-olds is because they are not of consent age.
She said that if the FDA cannot keep its original judgement that the pill be available by prescription only, that it at least not be available to all minors.
Paul Doering, professor emeritus in the University of Florida College of Pharmacy, said the age limit for Plan B One-Step is based on whether the use of the drug by people younger than the age of 15 is safe. He said an over-the-counter drug is one that does not require any input from a health professional.
Doering said proponents of the drug say the drug should be offered over the counter, because it is safe and effective. Opponents say the drug is not safe for use by young girls and may promote promiscuity.
“That’s a curious introspection of philosophy and science, and it’s very hard sometimes to separate the two,” he said. “There’s bound to be some public discussion about this because it’s really contrary to what the courts said recently, when they said there shouldn’t be any age limit.”
Doering said there was significant evidence pointing to Plan B being both safe and effective when used according to the labeled directions. He said the keys to a drug being safe for over-the-counter use is that it is safe and the directions are easily understood without any medical training.
He said that the latter qualification is what can be shaky because oftentimes the directions are not in “living room language.”
“I, personally, would like to see this medication in a third category of drugs,” he said. “Ones that a pharmacist could recommend, but only after a consultation with the potential user, to make sure that she is a good candidate for the use of this medicine.”
He said the truth of the issue is that studies have not tested whether 12-, 13- or 14-year-old girls could use the medicine, and questions whether the data from adult women could be extrapolated to include girls just reaching maturity. He said he is not sure that is a safe leap to make.
Doering said it is up to the manufacturer to do the testing, and the FDA will evaluate the study. He said it is more likely the case will be played out in the courtroom rather than in laboratories, because he couldn’t see companies recruiting young girls for the study.
“The sad part is, 12-, 13- and 14-year-old girls are not immune from becoming pregnant and becoming pregnant unexpectedly or unintentionally. It’s a mess right now,” he said.