The Plan B One-Step website says the drug primarily works to prevent the release of an egg from the ovary, reducing the possibility of pregnancy if taken within three days after sexual relations. However, if an egg has already been released, the company says it is possible that the drug may work by preventing the implantation in the womb, thereby ending the life of the newly formed human embryo.
That possibility drew intense objections from pro-life advocates like Hawkins, who denounced Plan B as “a dangerous abortion-inducing drug.”
“Girls who aren’t even old enough to drive themselves to the pharmacy are now being given free access to a megadose of a pill that ranks as a Group I carcinogen by the World Health Organization,” she explained.
Hawkins also warned that the drug is associated with blood clots, heart attacks and strokes, as well as triple the risk of ectopic pregnancy.
She objected to such a powerful and potentially dangerous drug being provided without parental permission or notification.
The FDA statement on the new rule cited a study submitted by the drugmaker Teva which said that women 15 years and older are able to understand that the drug is not for routine use and does not protect against sexually transmitted infections.
However, Higgins cautioned that over-the-counter sales could encourage unsafe repeat use.
“There is no good reason to believe that young girls understand that this drug is designed to be used only once per month and is not a substitute for oral contraception,” she said.
She added that the effects of taking the drug during puberty are unknown as there have been no studies on the subject.
In addition, Higgins charged that the decision undermines parents’ rights to help make medical decisions for their minor children.
“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,” she said.
She stressed that government policy should encourage parents and teens to communicate about the medical and moral issues involved in sexual behavior.
The FDA said its decision is independent of a federal judge’s April 2013 order that the federal agency remove all age restrictions on over-the-counter sales of Plan B One-Step.
(Story continues below)
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An FDA panel had previously tried to recommend lifting all age limits on the drug in 2011. However, Kathleen Sebelius, secretary of Health and Human Services, overruled the recommendation, citing “significant cognitive and behavioral differences” between older adolescent girls and the youngest girls of reproductive age, which may affect their ability to use the drug properly.
Prominent abortion advocacy groups have also blasted the FDA’s most recent decision, arguing that the change is not broad enough. They criticized the minimum age requirement and the identification requirement for purchasing the drug over-the-counter.
“These are daunting and sometimes insurmountable hoops women are forced to jump through,” said Nancy Northup, president and CEO of the Center for Reproductive Rights.
She joined leaders of NARAL Pro-Choice America in urging the FDA to remove all age restrictions on the morning-after pill, allowing children of any age to purchase it over-the-counter.