Judge lifts age restrictions on OTC morning after pill

Judge lifts age restrictions on OTC morning after pill
Judge lifts age restrictions on OTC morning after pill

In a reversal of an earlier Health and Human Services decision, a federal judge ruled today that the U.S. government must make levonorgestrel-containing emergency contraceptives Plan B and Plan B One-Step available over the counter for all ages, instead of requiring a prescription for girls aged 16 years and younger.

In 2011, HHS Secretary Kathleen Sebelius overruled an FDA recommendation to make the pill available for all ages without a prescription, in a move many have called political posturing. President Barack Obama supported Sebelius's decision.



Many have interpreted the President's stance on emergency contraception as political in nature, as it has become an issue in the abortion debate. Some have suggested enabling access to younger adolescents could prompt critics to accuse the Obama administration of supporting sexual activity for girls of that age.

In his decision, Judge Edward Korman of the U.S. District Court's Eastern District of N.Y., wrote that HHS's refusal to lift the restriction was “arbitrary, capricious, and unreasonable.”

Judge Korman has ordered the FDA to lift any age and sale restrictions on Plan B and its generic versions within 30 days.

"This decision reflects the overwhelming evidence that emergency contraception is safe and effective for all women of reproductive age, " the American Congress of Obstetricians and Gynecologists said in a statement on it's website.



In 2011, FDA Commissioner Margaret Hamburg, MD, issued a statement contending Plan B was "safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases."

Despite this endorsement, teens aged younger than 17 years had to obtain a prescription from a healthcare provider to access all forms of emergency contraception until Judge Korman's decision today.

"Removing the age restriction is a positive step forward, but providers must continue efforts to educate adolescents about the proper use of emergency contraception," Debra Katzman, MD, President of the Society of Adolescent Health and Medicine, said in a press release. "We must also work to ensure that emergency contraception is affordable for adolescents of limited means.”

Emergency contraception use can reduce the risk of pregnancy up to 120 hours after unprotected intercourse or contraceptive failure, and is most effective if used in the first 24 hours.

In addition to support from the ACOG, the judge's ruling has garnered support from the American Academy of Pediatrics, the Society of Adolescent Health and Medicine and Planned Parenthood. 

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