FDA: 15-year-olds can buy Plan B contraception

The Plan B One-Step (levonorgestrel) tablet.(AP Photo/Teva Women's Health)
The Plan B One-Step (levonorgestrel) tablet.(AP Photo/Teva Women's Health)
Posted: May 02, 2013

The Food and Drug Administration on Tuesday ruled the leading brand of emergency contraception may be sold without a prescription to females over 14.

However, the agency said the decision on Plan B One-Step would not affect the prescription status of two other morning-after pill products and was not in response to a federal judge's order.

Early last month, U.S. District Judge Edward Korman said Plan B One-Step must be available over the counter without restriction for all females of reproductive age and gave the FDA 30 days to comply.

Korman denounced the agency and Health and Human Services Secretary Kathleen Sebelius for delaying and denying a citizens' petition and subsequent lawsuit seeking over-the-counter sales. He said the decade-long battle over the pregnancy-prevention method was politically motivated.

Currently, only females 17 and older can get Plan B One-Step without a prescription. They must show a government-issued ID with proof of age to buy the product, which is kept behind the pharmacist's counter.

The FDA said it was responding to an application, long under review, from the maker of Plan B One-Step, Teva Women's Health, based in North Wales, Montgomery County.

Teva asked for over-the-counter access for females of all ages, but when the FDA refused in December 2011, the company amended its request, adding the age threshold of 15.

Emergency contraception, which contains the same hormones found in regular birth-control pills, reduces the chance of pregnancy if taken within 72 hours of unprotected sex.

The FDA said its decision was based on studies that Teva submitted to support its application, a willingness to do an age-verification sales audit, and its "plans to educate consumers, pharmacy staff, and health care professionals about the product's new status."

Although the product will no longer have to be kept behind pharmacy counters, the FDA said buyers would be required to prove their age at the cash register.

"The FDA's approval of Teva's application . . . is not intended to address the judge's ruling," the agency's statement said. "The Department of Justice is considering next steps in the litigation."

Critics have argued that easy access to Plan B would encourage sexual activity, and some have likened it to an abortion pill.

Some contraceptive advocates called the FDA action promising.

"This decision is a step in the right direction for increased access to a product that is a safe and effective method of preventing unintended pregnancies," said Sen. Patty Murray (D., Wash.). "It's also a decision that moves us closer to these critical availability decisions being based on science, not politics."

But the women's group that sued over the age limits said that Tuesday's action was not enough and plans to continue its court fight.

Lowering the age limit "may reduce delays for some young women, but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification," said Nancy Northup, president of the Center for Reproductive Rights.

The FDA said the Plan B One-Step would be packaged with a product code that prompts the cashier to verify a customer's age. Anyone who can't provide such proof as a driver's license, birth certificate, or passport would not be allowed to complete the purchase.

"These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women," Northup said.

Half of the nation's pregnancies every year are unintended, and doctors' groups say more access to morning-after pills could cut those numbers.


Contact Marie McCullough

at 215-854-2720 or mmccullough@phillynews.com.

This article contains information from the Associated Press.

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