FDA approves over-the-counter sales for Plan B

Women and girls age 15 and over will soon be able to buy emergency contraception without a prescription.

The Food and Drug Administration announced on Tuesday that it was approving Plan B One-Step, also known as the morning-after pill, to be sold in the retail aisle next to other over-the-counter medications. Customers will not have to ask a pharmacist for it.

FDA officials say the announcement is unrelated to a federal judge's order earlier this month, which gave the agency 30 days to make the pill available to all girls and women without a prescription, regardless of age.

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

In his April 5th ruling,U.S. District Court Judge Edward Korman noted that emergency contraception has been shown to be extremely safe, and that the FDA's age limits were arbitrary.

"FDA has engaged in intolerable delays," Korman said, amounting to an "administration agency filibuster."

Korman's ruling was in response to a lawsuit by the Center for Reproductive Rights, which sued to expand access to emergency contraception, which can prevent pregnancy if taken within three days of unprotected sex or contraceptive failure.

Plan B One-Step, a single pill containing a hormone found in birth control pills, sold by Teva Women's Health, does not terminate an existing pregnancy and does not harm a developing fetus, the FDA said.

About half of pregnancies are unintended, studies show.

FDA spokeswoman Erica Jefferson said the Tuesday approval "is independent of the judge's ruling and is not intended to address it."

In an interview with USA TODAY's Editorial Board last week, FDA Commissioner Margaret Hamburg said the agency had not yet decided how to respond to the judge's order. Jefferson said the Department of Justice handles litigation, and said all questions about the judge's order should be referred to that agency.

Now, customers will be able to buy Plan B One-Step just as they would purchase condoms. But girls will have to show an ID to prove their age, the FDA said.

"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," said Nancy Northup, president and CEO of the Center for Reproductive Rights, in a statement.

"Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step 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 or after the pharmacy gates have been closed for the night or weekend. 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."

Emergency contraception has had a long history with the FDA. The drug was first approved in 1993.

In 2011, the FDA was about to approve an application from its manufacturer, Teva Women's Health, to sell it over the counter. President Obama expressed concerns, however, and Secretary of Health and Human Secretary Kathleen Sebelius overruled the FDA.

When its application to sell Plan B One-Step over-the-counter without age restrictions was rejected, Teva submitted a new application, requesting approval for those 15 and up, the FDA said.

That application, asking for approval for those 15 and up, was filed before the judge's ruling, Jefferson said.

At the time of the judge's ruling, the Family Research Council's Anna Higgins said, "Making Plan B available for girls under the age of 17 without a prescription flies in the face of medical information and sound judgment."

Higgins also expressed concern that the over-the-counter availability of Plan B for girls of any age would put many at further risk of sexually transmitted infections.

In a statement, Planned Parenthood Federation of America officials praised the FDA's decision, although the group also encouraged the FDA to lift all restrictions on emergency contraception, as mandated by the court.

"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," Planned Parenthood President Cecile Richards said. "This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy."

Other forms of emergency contraception have been approved. A two-dose version of Plan B is available generically and available to women 17 and up without a prescription. It requires a prescription for girls under age 17. Another version, sold as Ella, is sold only with a prescription and is approved to prevent pregnancy within five days of unprotected sex or contraceptive failure.

Article Source - http://www.usatoday.com/story/news/nation/2013/04/30/fda-plan-b-over-the-counter-emergency-contraception/2125131/