FDA Backs Down, Will Allow Over-the-Counter Sale of Emergency Contraceptive Without Age Limits

An emergency contraceptive will soon be available to adolescent girls without a prescription. (Image: Teva Pharmaceuticals)

An emergency contraceptive will soon be available to adolescent girls without a prescription. (Image: Teva Pharmaceuticals)

Ending more than a decade of foot-dragging by 2 US administrations, the Department of Justice has informed a federal district court it will no longer fight the designation of over-the-counter status to the Plan B One-Step emergency contraceptive for women and girls.

The letter, sent late Monday to US District Judge Edward R. Korman of the Eastern District of New York, said the US Food and Drug Administration (FDA) had invited Teva Branded Pharmaceutical Products R&D Inc to “promptly submit a supplemental new drug application with proposed labeling that would permit Plan B One-Step to be sold without a prescription and without age or point-of-sale restrictions.” Upon receiving this application, the agency will approve without delay, the letter said.

Emergency contraceptive products were first approved by the FDA in 1998 to prevent pregnancy if taken within 3 days of unprotected intercourse. The availability of these so-called morning-after pills created politically turbulent waters, as antiabortion and women’s reproductive rights groups sparred over ease-of-access issues for these medications. These debates were reflected in actions by the administration.

In 2003, the FDA disregarded an advisory committee recommendation to make emergency contraceptives available over the counter. The agency finally did so in 2006, but only for women aged 18 years or older. In 2009, Judge Korman ordered the FDA to lower the over-the-counter age limit to 17 years. In 2011, the FDA was ready to approve over-the-counter sales of Plan B One-Step to adolescents younger than 17 years, but the agency was overruled by Department of Health and Human Services Secretary Kathleen Sebelius. In early April of this year, Korman ordered the FDA to make the contraceptive available over the counter to adolescents, but the FDA appealed—until yesterday.

Planned Parenthood Federation of America expressed approval that the administration has given up the fight. “This is a huge breakthrough for access to birth control and a historic moment for women’s health and equity,” said Planned Parenthood President Cecile Richards in a release.



Categories: Women's Contraception, Women's Health