News Column

FDA Approves OTC Sales for Plan B

May 2, 2013

Women and girls age 15 and older 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 this month that 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. 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, adding that a passport or birth certificate would work.

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. It can prevent pregnancy if taken within three days of unprotected sex or contraceptive failure.

About half of pregnancies are unintended, studies show.

FDA spokeswoman Erica Jefferson said that the Department of Justice handles litigation and that all questions about the judge's order this month should be referred to that agency.

"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 statement. Her group has sued to expand access to emergency contraception.

"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" Northup said. "These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances."

Emergency contraception 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, but President Obama expressed concerns, and Secretary of Health and Human Services Kathleen Sebelius overruled the FDA.

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.



Source: Copyright USA TODAY 2013


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