As Healthland reported yesterday, the Food and Drug Administration (FDA) was preparing to remove the age restriction on the emergency contraception pill, Plan B One-Step, allowing its sale to teens under 17 without a prescription. On Wednesday, FDA Commissioner Margaret Hamburg announced she had deemed the drug safe for younger teens and recommended that it be sold over the counter, but in a surprising turn, was overruled by Health and Human Services Secretary Kathleen Sebelius.
In a statement, Hamburg said:
I reviewed and thoughtfully considered the data, clinical information, and analysis provided by [the Center for Drug Evaluation and Research], 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, on Wednesday morning, Hamburg said, she received a memo from Sebelius disagreeing with the FDA’s recommendation and instructing the agency to maintain the age restriction on the drug.
The FDA’s decision was based largely on data from two trials, submitted by Plan B One-Step’s manufacturer, Teva Pharmaceuticals, which applied in February to make the drug freely available without a prescription. Currently, the drug is available to teens 17 or older over the counter, but teens under 17 still need a prescription.
One study reviewed by the FDA, involving 335 girls aged 12 to 17, showed that 72% to 96% of them understood the proposed Plan B One-Step package label well enough to use emergency contraception safely and effectively without consulting a doctor. Another study, involving about 300 girls aged 11 to 16 also found that they could use the drug properly on their own.
Invoking her authority under the Federal Food, Drug, and Cosmetic Act, however, Sebelius blocked the move to lift the age restriction, citing insufficient medical evidence. She said:
[T]he switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.
Sebelius’ memo goes on to explain that although the average age of menstruation is about 12 for American girls, some 10% of girls start having their period earlier, by age 11. Noting that it is “common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” Sebelius suggests that it may not be safe for younger teens who would be eligible to use Plan B One-Step to do so without consulting a doctor.
“Because 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, I have directed FDA to issue a complete response letter denying the supplemental new drug application by Teva Women’s Health, Inc.,” Sebelius said.
Critics of the move believe the decision was based on anything but science. “We’re outraged by this interference with the judgment of scientists at the FDA and dismayed that women will continue to face the barriers created by this medically unjustified age restriction,” says Amy Allina, director of programming for the National Women’s Health Network, in response to Sebelius’ ruling. “We thank Commissioner Hamburg for making the process transparent and letting the world know that the FDA believes [emergency contraception] is safe enough for over-the-counter use by women of all ages.”
Plan B One-Step will remain on the market, and will continue to be available to men and women age of 17 or older without a prescription. Younger teens will need a prescription from a doctor to purchase the drug.