Girls under the age of 17 will still need a prescription to obtain the so-called morning-after pill known as Plan B, U.S. regulators said Wednesday.
Kathleen Sebelius, the secretary of health and human services, overruled the finding of the Food and Drug Administration that Plan B One-Step could be safely dispensed to younger girls over the counter, FDA Commissioner Margaret Hamburg said. Plan B One-Step has been available to those 17 and older without prescription since 2009.
Teva Women's Health Inc. petitioned for the change earlier this year.
Hamburg, in a statement, made her disagreement with the secretary clear. She said she had reviewed the findings of the Center for Drug Evaluation and Research.
"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 non-prescription use for all females of child-bearing potential," Hamburg said.
Plan B can prevent pregnancy if taken within three days of having unprotected sex. Some abortion opponents consider the pill a means of abortion because it prevents implantation, not conception.