Sebelius blocks OTC morning-after pill for young girls

In what the AP described as a “surprise move,” Secretary of Health and Human Services Kathleen Sebelius yesterday rejected the Food and Drug Administration’s plan to make the “emergency contraceptive” Plan B One-Step available to girls under 17 without a prescription.

Sebelius’ reason: Some girls as young as 11 are physically capable of bearing children, and Plan B’s maker didn’t prove that younger girls could properly understand how to use this product without guidance from an adult. 

“It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” Sebelius said in a statement. “I do not believe enough data were presented to support the application to make Plan B One-Step available over-the-counter for all girls of reproductive age.”

Sebelius’ decision has upset liberal activists as well as those working under the HHS secretary at the FDA:

“We are outraged that this administration has let politics trump science,” said Kirsten Moore of the Reproductive Health Technologies Project, an advocacy group. “There is no rationale for this move.” 

“What else can this be but politics?” said Cynthia Pearson, executive director of the National Women’s Health Network, an advocacy group that supports making Plan B available to all ages. “It’s not science. It’s not medicine. It’s not women’s health.” 

Indeed, FDA Commissioner Dr. Margaret Hamburg made clear in her own statement that the decision is highly unusual. She said her agency’s drug-safety experts had carefully considered the question of young girls and that she had agreed that Plan B’s age limit should be lifted. 

“There is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,” Hamburg wrote.

The AP’s follow-up story today quotes an Obama administration official backing up Sebelius’ decision, as well as several activists, politicians, and physicians who are angered by the move:

“Secretary Sebelius took this action after careful review,” Obama spokesman Nick Papas said. “As the secretary has stated, Plan B will remain available to all women who need it, and the president supports the secretary’s decision.”

Sebelius’ decision is “medically inexplicable,” said Dr. Robert Block of the American Academy of Pediatrics.

“I don’t think 11-year-olds go into Rite Aid and buy anything,” much less a single pill that costs about $50, added fellow AAP member Dr. Cora Breuner, a professor of pediatric and adolescent medicine at the University of Washington.

Instead, putting the morning-after pill next to the condoms and spermicides would increase access for those of more sexually active ages “who have made a serious error in having unprotected sex and should be able to respond to that kind of lack of judgment in a way that is timely as opposed to having to suffer permanent consequences,” she said.