HHS keeps age restrictions for morning-after pill
WASHINGTON — US regulators rejected Wednesday a drug company’s request to make emergency contraception available over the counter to consumers of all ages instead of by prescription.
US Food and Drug Administration chief Margaret Hamburg sent a letter to reporters explaining she supports the move to allow the morning-after pill to be easily available to girls 12 and over.
However, she said Health and Human Services Secretary Kathleen Sebelius disagreed with the FDA decision, and had invoked her authority to block the supplement for non-prescription use for females under 17.
“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,” Hamburg said.
Currently, the morning-after pill — which can reduce the chance of pregnancy if taken within 72 hours of unprotected sex — is available by prescription only to people under 17 in the United States.
Those over 17 can ask for it at a pharmacy counter without a doctor’s prescription.
Teva Pharmaceuticals, maker of Plan B One-Step, asked the FDA to change its rules to allow it to be easily accessible to all ages.
The attempt drew opposition from conservative pro-life groups, but was supported by pro-choice organizations.
“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.
“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.”
The pill in question contains 1.5 milligrams of levonorgestrel and it can percent pregnancy if taken within three days of unprotected sex. It contains higher levels of the hormone found in birth control pills.
Plan B One-Step was first approved in 2009 for use without a prescription in those aged 17 and over, but was available to younger girls with a doctor’s prescription.
Hamburg said she found the review by the Center for Drug Evaluation and Research (CDER), which makes recommendations to the FDA, was enough to allow the pill to be available on drugstore shelves.
“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,” the FDA chief said.
Hamburg said the panel had found that “adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases… (and they) could use Plan B One-Step properly without the intervention of a healthcare provider.”