Plan B Pill
December 8, 2011 by staff
Plan B Pill, The emergency contraceptive Plan B will not be made available over the counter to younger teens, the Food and Drug Administration announced Wednesday, exposing a rift between the agency and the U.S. Department of Health and Human Services.
Teva, the manufacturer of the oral contraceptive that can be taken up to 72 hours after sex to prevent the implantation of a fertilized egg, requested approval from the FDA in February to make the drug available without a prescription to girls ages 16 and younger.
Currently, the drug, commonly known as the morning-after pill, is available without a prescription to women 17 and older, and is kept behind the pharmacy counter.
FDA commissioner Margaret Hamburg expressed support for expanding access for the drug without a prescription.
“I reviewed and thoughtfully considered the data, clinical information andanlysis 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,” Hamburg said in a statement.
However, Hamburg said she was informed Wednesday morning that HHS Secretary Kathleen Sebelius disagreed with the FDA’s determination, and therefore the request by Teva will not be approved.
“The 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,” Sebelius said in a statement. “I do not believe that Teva’s application met that standard.”
The FDA said it was the first time the HHS has reversed one of its decisions.
The drug will remain on the market, but girls younger than 17 must have a prescription.
Rep. Michael Burgess, a Texas Republican who opposed approval of Plan B for over-the-counter use in girls younger than 17, said he was pleased by the decision, but called it a political one by Democrats.
“It’s a presidential election year,” Burgess said in a telephone interview with Bloomberg News. “This is a striking departure from where congressional Democrats and the administration has been in the past.”
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