Putting an age restriction on buying the most common emergency contraception over the counter was never sound from a medical point of view. Now a federal judge has upset the political calculus behind the restriction, as well.
By the time the U.S. Food and Drug Administration decided, in late 2011, to lift the rule that girls under age 17 need a prescription for Teva Pharmaceutical Industries Ltd.’s Plan B, the pill’s safety was well-established. What’s more, research had shown that the drug, which had been characterized as an abortion pill, was nothing of the sort. It works by interfering with fertilization. There’s no evidence that it blocks the development of an already fertilized egg.
Yet Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s decision, and President Barack Obama endorsed her unprecedented action, arguing that, without an age limit, a 10- or 11-year-old could go to a drugstore and ― “alongside bubble gum or batteries ― be able to buy a medication that potentially, if not used properly, could end up having an adverse effect.”
However, as federal Judge Edward R. Korman pointed out today in overruling Sebelius’s action, when it comes to safety, “the standards are the same for aspirin and for contraceptives.”
If anything, age restrictions on the morning-after pill are a bigger problem than they would be for pain relievers. Many doctors have explained why. The pill is most effective if taken within 24 hours of unprotected sex; there often isn’t time for users to see a doctor before going to the pharmacy. Last November, the American Academy of Pediatrics recommended that its members work around the age restriction by prescribing the drug to teens in advance. (The American Medical Association and the American College of Obstetricians and Gynecologists also support making the morning-after pill available with no restrictions.)
Korman denounced Sebelius’s interference in FDA decision- making just as he had earlier denounced efforts by President George W. Bush’s White House to delay FDA action on the morning- after pill. The reasons Sebelius gave for her move ― including “cognitive and behavioral” differences in the youngest reproductive-age girls ― were “so unpersuasive as to call into question her good faith,” the judge said.
Korman instructed the FDA to make emergency contraceptives available with no prescription or age restrictions within 30 days.
Now Sebelius must decide whether to appeal the ruling. With the presidential election that loomed over the secretary’s 2011 action well past, she should let the judge’s order stand.
