FDA Approves Over-the-Counter Plan B for Women 15 and Older
FDA didn't disobey judge on Plan B, but made separate rule.
May 1, 2013— -- The Food and Drug Administration has approved Plan B One Step, a brand of emergency contraceptive, to be available for women 15 and older without a prescription.
This comes almost a month after a federal judge ordered the FDA to make Plan B available to everyone over-the-counter, which will go into effect on May 5, unless the FDA appeals the ruling.
"The Department of Justice is considering next steps in the litigation," the FDA said in a statement. "In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older."
Judge Edward Korman ordered emergency contraceptive to be made available over the counter on April 5, citing "bad faith" that resulted in restricted access to the drug in the past. Prior to that, it was available to everyone 17 and older without a prescription.
When Korman, who presides over the District Court of Eastern New York, wrote his ruling, Teva Pharmaceutical Industries, which makes Plan B One-Step, had an application pending with the FDA to get the prescription-free age lowered from 17 to 15, according to the FDA statement.
"While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," said President of Planned Parenthood Federation of America's President Cecile Richards.
The morning after pill is intended to be used when other contraception fails, such as when a condom breaks. Containing the synthetic hormone levonorgestrel, the pill works by preventing a fertilized egg from attaching itself to the uterine wall. But it must be taken within 72 hours of unprotected sex. It cannot terminate an existing pregnancy.
Although today's FDA approval means women seeking Plan B will need to have identification to prove they are of age to purchase it, the drug will no longer be available only when the pharmacy is open, according to an FDA statement. Instead, it will be available in the family planning and female health aisles.
In December 2011, Health and Human Services Secretary Kathleen Sebelius sparked controversy when she overruled the FDA after it recommended that emergency contraception be sold over the counter. The FDA spent 10 months reviewing scientific data before making its decision, but Sebelius said there wasn't enough data to declare the product safe.
"Indeed, it is hardly clear that the secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious and unreasonable," Korman wrote in his ruling.
Although the FDA has not yet made an announcement regarding Korman's order, some women's health organizations are concerned.
"The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday," Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a press release.
She said requiring proof of age is a "significant barrier that all too many women of all ages will still find" even with the prescription-free age lowered to 15.
"These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances," she said. "And we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women."
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