NEW: "We are very disappointed," says the head of a reproductive medicine group
Maker of Plan B One-Step had asked that it be available OTC to all sexually active girls and women
FDA found pill "safe and effective," but HHS secretary says more data needed
The secretary of Health and Human Services overruled Wednesday a Food and Drug Administration recommendation that would have made the emergency contraceptive pill Plan B One-Step available over the counter to girls younger than 17.
In February, Teva Woman’s Health Inc, the drug maker, had asked the FDA to make the drug available without prescription to all sexually active girls and women.
At the time, FDA Commissioner Dr. Margaret Hamburg said that, after reviewing all relevant data, “Plan B One Step is safe and effective and should be approved for non-prescription use for all females of child-bearing potential.”
But HHS Secretary Kathleen Sebelius overruled that recommendation. “Because I do not believe enough data were presented to support the application … I have directed FDA to issue a complete response letter denying the supplemental new drug application,” she said in a statement.
In July 2009, Plan B was approved for use without a prescription for females aged 17 and older, but girls under 17 needed a prescription.
Emergency contraceptives prevent a pregnancy by preventing a fertilized egg from embedding in the uterus. They are intended for use within 72 hours after sex, but are most effective if taken within 24 hours. Proponents say requiring a prescription can delay access to the drug.
Wednesday’s decision was criticized by the American Society for Reproductive Medicine, which counts more than 8,000 members.
“We are very disappointed that Secretary Sebelius opted to insert herself into what should be a scientific decision made by the experts at FDA,” said the group’s president, Dolores J. Lamb. “The data are clear that emergency contraception can be safely used by adolescent women without requiring a prescription. Sadly, it appears that once again our leaders are putting political expediency ahead of reproductive health.”
But Dr. Lisa Flowers, associate professor in the Department of Obstetrics and Gynecology at Emory University’s School of Medicine, said Sebelius’ decision “might be the right thing to do until we get a really good system by which we can educate young kids about prevention of pregnancy and understanding the risks of getting involved in sexual intercourse, and what are the outcomes.”
Flowers suggested the FDA consider allowing over-the-counter access for girls under the age of 17 if they are accompanied by a parent to the drugstore.