FDA Allows 'Morning After Pill' To Be Sold To Some Teenagers Without A Prescription
If a teenage girl can get a learner’s permit, she can now probably get the morning-after pill to prevent pregnancy after unprotected sex. But advocates of the emergency contraceptive say that is still not enough access.
The Food and Drug Administration announced this afternoon that it had approved the Plan B contraceptive, which lowers the risk of pregnancy when taken within 72 hours after sexual intercourse, for sale over-the-counter to girls as young as 15.
However, in a step that could dramatically reduce the impact of the approval, the FDA is requiring that those who purchase Plan B at a drugstore have legal proof of age such as a driver’s license or non-driver identification card. Because many 15-year-olds might not have driver’s licenses or learner’s permits, many might not be able to purchase the contraceptive. When asked what alternatives could be used, an FDA spokeswoman wrote back: “a passport or birth certificate.” Until now, Plan B, which is made by generic drug giant TEVA Pharmaceuticals, was available at pharmacy counters to anyone over 17. The minimum age for a learner’s permit ranges from 14 to 16, depending on the state. (Data are here.)
In December 2011, the FDA, all the way up to Commissioner Margaret Hamburg, had decided to approve Plan B over-the-counter for women and girls without an age restriction. But Kathleen Sebelius, the head of the Department of Health and Human Services, took the unprecedented step of over-ruling that decision. It was the first time the FDA’s authority had ever been threatened by higher-up in the executive branch. This was a potentially dangerous long-term step, because it weakens the agency’s authority to regulate drugs.
Earlier this month, U.S. District Judge Edward Korman in Brooklyn, New York, ruled that Plan B could be made available without a prescription, over-ruling the Obama administration’s decision. The FDA said that its ruling today was not a response to Korman’s verdict.Korman’s decision can be read here.
“These emergency contraceptives would be among the safest drugs sold over the counter,” Korman wrote, and “the number of 11-year-olds using these drugs is likely to be minuscule.”
Plan B does not cause an abortion. According to the drug’s web site:
Plan B One-Step® is one pill that has a higher dose of levonorgestrel, a hormone found in many birth control pills that healthcare professionals have been prescribing for several decades. Plan B One-Step® works in a similar way to help prevent pregnancy from happening. It works mainly by stopping the release of an egg from the ovary. It is possible that Plan B One-Step® may also work by preventing fertilization of an egg (the uniting of the sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).
Proponents of making it available over-the-counter note that the effectiveness of the pill fades as time passes; in order for it to work, it should be taken as soon as possible. Opponents say that children as young as their early teen years should not be making medical decisions without consulting their parents.
The Plan B contraceptive does not prevent transmission of sexually transmitted diseases, as condoms do, and is not recommended as a regular method of birth control. Other methods are more effective and have fewer unpleasant side effects, which can include nausea and abdominal pain.
In 2005, Susan Wood, then head of Office of Woman’s Health at the FDA, quit because then-commissioner Lester Crawford was delaying approving expanded use of the Plan B emergency contraceptive. She called today’s approval “incremental progress” but said she’d hoped for better.
“Unfortunately, though a step in the right direction, this action is still not consistent with the medical and scientific evidence – or indeed with the FDA decision back in 2011 that was overruled by HHS. There is no need for an age restriction or prescription requirement for younger teens in need of emergency contraception.” The court case, she noted, will continue. Wood is currently the director of the Jacobs Institute of Women’s Health at The George Washington University, where she is also an associate professor.
The over-the-counter Plan B OneStep costs about $50.
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