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FDA's 'Plan B' Plan Isn't What the Judge Ordered

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By Aditi Mukherji, JD on May 01, 2013 12:26 PM

Women and girls age 15 and over will soon be able to buy the Plan B "morning-after pill" without a prescription, thanks to a new FDA decision.

The Food and Drug Administration (FDA) is approving Plan B One-Step, commonly known as the "morning-after pill," to be sold over-the-counter alongside items like cough syrup and pain relievers.

The FDA's Plan B approval is a big deal in two ways:

  1. It lowers the age restriction on prescriptionless purchases from 17 to 15, and
  2. Customers will no longer have to ask a pharmacist for it.

FDA officials say its announcement is unrelated to a federal judge's order earlier this month. In that case, the judge gave the FDA 30 days to do away with age and point-of-sale restrictions that prevent women from having easy access to emergency contraception.

Rather, the FDA's ammouncement on Tuesday was simply a response to an application by Teva, the drug's maker, to lower the age restriction. That application was filed before the federal judge's order.

Until now, women have had to ask a pharmacist for emergency contraception. Those under 17 could get the pill only with a prescription.

Even for women over 17 who didn't need a prescription, getting the morning-after pill was often difficult. This is primarily because some pharmacists place their personal morals above the law and unlawfully block access to it. Making the pill available over-the-counter helps to remove that barrier.

In his April 5 ruling, U.S. District Court Judge Edward Korman pointed to several studies that showed Plan B contraception to be extremely safe, and that the FDA's age limits were basically arbitrary, reports USA Today.

But the FDA hasn't yet found a way to swallow that order. Though the judge ruled that the pill shouldn't come with any age restrictions at all, the FDA's action only lowers the age restriction from 17 to 15. To prove their age, girls will have to show a valid ID.

The FDA is still figuring out how to respond to Judge Korman's order to make Plan B One-Step available without restriction for everyone, an FDA commissioner told USA Today. The deadline to comply with Korman's order is Monday.

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