The long, strange trip for an important drug continues, as politics keeps harassing science.
On Tuesday, the U.S. Food and Drug Administration announced it will allow the emergency contraceptive pill Plan B One-Step to be sold over the counter to girls as young as 15. The feds’ action came just five days before the deadline set by U.S. District Judge Edward Korman nearly a month ago. He tossed the previous age limit of 17, set by U.S Health and Human Services Secretary Kathleen Sebelius, saying the FDA’s own scientists concluded that teens could handle the drug just as competently and safely as adults.
The next step for One-Step, the most common emergency contraceptive, is waiting to see whether the judge forces the FDA to come up with its own plan B, because he may still balk at an age restriction.
Anticipating that possibility, the U.S. Department of Justice announced Wednesday that it would appeal Korman’s April 5 ruling and asked him to stay his order to make One-Step available regardless of age.
The drug best prevents an unwanted pregnancy when taken in the first 24 hours after unprotected sex, so any delays must be taken seriously. That’s why it was important for the drug to be made available over the counter. From 1999 to 2006, women 18 and older could get it if they had prescription, but by the time some women got to the doctor, it was too late. It’s been sold over the counter to women 17 and older since 2009, making it available when a pharmacist isn’t on duty. In 2011, the FDA ruled that the age limit should be dropped, but Sebelius took the unprecedented step of publicly blocking the agency.
Age restrictions cause critical delays because young women are asked for identification. Many girls, particularly those too young to have a driver’s license or learner’s permit – and certainly too young to be mothers – don’t carry valid identification, such as a passport or birth certificate. If they can’t produce an ID, they won’t get the drug.
The reason the drug is so controversial is tied up in the issues of abortion, contraception and parental notification. Some people believe the drug induces abortions, but that isn’t the case. It doesn’t work on pregnant women. Others don’t like it because they believe the availability of contraceptives is an inducement to an irresponsible act. The reality is that young people will have sex, so it’s wise to encourage the use of contraceptives to prevent diseases and unwanted pregnancies.
Sebelius, backed by President Barack Obama, believes parents should be aware of what’s happening. That is, of course, what any responsible parent would want, but there are many young women who don’t have trustworthy adults they can turn to. Denying them an emergency contraceptive could be consigning them to an unwanted pregnancy or an abortion.
The Justice Department’s appeal won’t affect the new FDA age limit of 15 and older, but it would set up a legal challenge if Korman believes the lowered age limit is still based on politics.
It ought to be driven by science.
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