Age Restriction Removed on OTC Morning After Pill

A federal judge has reversed an HHS decision that restricted over-the-counter access to the levonorgestrel-containing emergency contraceptives Plan B and Plan B One-Step (morning after pill) to women and girls 17 and older.

In his ruling, Judge Edward Korman of the U.S. District Court’s Eastern District of N.Y. cited political pressure as a reason for the 2011 decision by Department of Health and Human Services secretary Kathleen Sebeliusthat prevented the FDA from expanding over-the-counter access to the pills without age restrictions, as the agency had planned.

“Secretary Sebelius’s directive to the FDA … forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability,” Korman wrote in his opinion yesterday.

He ordered the FDA to “make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within 30 days.”

Nancy Northup, president and CEO of the Center for Reproductive Rights, one of the plaintiffs in the court case, said the ruling “has swept away all the FDA’s stalling, all the interfering, and all the political gamesmanship.”

The message is clear, she said on a conference call with reporters: “Women’s reproductive health and access to reproductive healthcare must never be held hostage by politics.”

Plan B was first approved for use in 1999 by prescription only; the FDA granted over-the-counter access to the pill for women 18 and older while maintaining the prescription requirement for younger females in 2006. That decision followed a denial of a Citizen Petition from reproductive-rights groups seeking over-the-counter access for all age groups.

In 2009, Korman ruled that the FDA must make the pill available without a prescription for 17-year-olds as well, concluding that the FDA’s denial of the Citizen Petition was “arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making.”

Korman agreed that “the FDA bowed to political pressure emanating from the White House and departed from agency policy.” He did not remove all age restrictions at that time, deciding instead to leave the decision to the FDA, which had come under new leadership after President Barack Obama was elected.

The single-pill version of the drug — Plan B One-Step — was approved later that year and was subject to the same age restrictions.

The manufacturer — Teva Women’s Health — then submitted a supplemental new drug application seeking to allow over-the-counter access to girls and women of all ages.

The FDA initially approved the application, and commissioner Margaret Hamburg, MD, explained that the agency “determined that the product 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.”

Sebelius disagreed with the decision, however, and ordered the FDA to deny that application, stating “that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages.” President Obama supported the decision.

Korman reversed that decision yesterday, but left open the possibility of further action from the FDA.

“On remand, the FDA may determine whether any new labeling is reasonably necessary,” he wrote. “Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product.”

The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the Society of Adolescent Health and Medicine, and Planned Parenthood all came out in support of the judge’s ruling.

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