WEDNESDAY, Dec. 7 (HealthDay News) -- The emergency contraceptive called Plan B will not be made available without a prescription to young women under the age of 17, U.S. Health and Human Services Secretary Kathleen Sebelius announced Wednesday.
The surprise move came the same day that the U.S. Food and Drug Administration was expected make the controversial drug available to all females without a prescription.
Sebelius said she was concerned that very young girls couldn't properly understand how to use the drug without assistance from an adult, according to news reports.
The decision means that teens 16 and younger can only buy Plan B, which costs about $50, with a prescription. Teens 17 and older, however, can continue to purchase the so-called morning-after pill without a prescription if they provide proof of age.
Plan B prevents pregnancy if taken within three days after having sex, according to the manufacturer, Israel-based Teva Pharmaceutical Industries Ltd.
Following Sebelius' announcement, FDA Commissioner Dr. Margaret Hamburg issued a statement that said her agency had found "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," she added, "this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the agency's decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA's determination, the secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved."
Plan B p
All rights reserved