HHS says no to over-the-counter Plan B for kids

December 7, 2011 11:04:22 AM PST
The Food and Drug Administration was considering a measure to lower the age for those who can buy the Plan B emergency contraceptive without a prescription, but the secretary of Health and Human Services stepped in and ruled the restrictions remain the same.

The pill could have become an over-the-counter contraceptive available to teens 16 and younger. But Kathleen Sebelius overruled the FDA, saying she was concerned that 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."

Non-prescription purchases are currently restricted to those 17 and older.

Conservative groups say the drug should not be sold without medical oversight or parental involvement.

Sebelius' decision was a surprise move overruling her own experts, who were preparing to let it be sold on drugstore shelves like condoms.

FDA Commissioner Dr. Margaret Hamburg released the following statement:

"I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that 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. However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency's decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA's determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius's direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17."

The ruling was the latest twist in a nearly decade-long push for over-the-counter sales of pills that can prevent pregnancy if taken soon enough after unprotected sex. Major doctors' groups and women's health advocates say easier, quicker access to those pills could cut the nation's high number of unplanned pregnancies.

The decision shocked maker Teva Pharmaceuticals, which had been gearing up for over-the-counter sales to begin by month's end, and women's health groups.

"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."

Already, the FDA's age limits have gone to court. In 2009, a federal judge said the agency had set them initially based on politics, not science, and ordered the agency to reconsider. A hearing already was scheduled for next week to consider whether the FDA should be held in contempt of court for not doing so earlier.

(The Associated Press contributed to this report.)