Previously, the FDA allowed only teens 17 and older to obtain Plan B One-Step off the shelf. The decision Tuesday (April 30) lowers that age by two years, meaning teens who can't yet drive will be able to obtain the drug in the aisle of a drug or grocery store without involvement by a parent or health care professional.
Proof of age will be required to purchase it, with the package including a "product code" prompting the cashier to request identification. Additionally, the drug's packaging will include the label "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified."
Plan B One-Step works in part by restricting ovulation or preventing fertilization. It is its back-up mechanism that draws opposition from pro-lifers. According to the FDA website, the back-up mechanism works post-fertilization by "preventing attachment" of a tiny embryo to the uterine wall. Pro-lifers consider it a chemical abortion.
The drug sometimes is called a "morning-after pill." To work, it must be taken within three days of sex. According to the FDA, Plan B One-Step fails to work one out of eight times.
The FDA's announcement came less than a month after a federal judge ordered the agency to make a sister drug, known simply as Plan B, available to teens of any age without a prescription. That decision was heavily criticized because even pre-teens could obtain the drug without a prescription. In its April 30 announcement, the FDA said its decision was made independent of the judge's ruling and that the Justice Department has yet to decide whether to file an appeal.
Teva Women's Health, the maker of Plan B One-Step, had submitted the application prior to the judge's ruling, the FDA said.
"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," FDA Commissioner Margaret A. Hamburg said in a statement.
Anna Higgins, the Family Research Council's director of the Center for Human Dignity, said the FDA's decision is wrong.
"The effects of taking a high dose of a systematically absorbed hormone during puberty are unknown," Higgins said. "There have been no studies on the drug's effect on young girls. ... If Plan B is available , teens and women will avoid necessary medical screenings during which serious medical problems like STI's 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."
The FDA's decision also infringes on the rights of parents, Higgins said.
"This decision undermines the right of parents to make important health decisions for their young daughters," she said. "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."
In limiting the sale of Plan B One-Step to women 17 and older in 2011, Kathleen Sebelius, the secretary of the Department of Health and Human Services, had argued that girls as young as 11 could not be trusted to use the drug properly. President Obama supported her at the time.
"The reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old into a drugstore should be able -- alongside bubble gum or batteries -- be able to buy a medication that potentially, if not used properly, could end up having an adverse effect," Obama said then.
About 10 percent of girls reach reproductive age at 11, although the average age is 12.
Michael Foust is associate editor of Baptist Press. Get Baptist Press headlines and breaking news on Twitter (@BaptistPress), Facebook (Facebook.com/BaptistPress ) and in your email ( baptistpress.com/SubscribeBP.asp).
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