WEDNESDAY, Dec. 7, 2011 (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 prevents implantation of a fertilized egg in a woman's uterus through use of levonorgestrel, a synthetic hormone used for decades in birth control pills. Plan B contains 1.5 milligrams of levonorgestrel, more than "the Pill" contains.
The drug maker said that Plan B is safe for younger teens and that they should have it available to them as needed. The company submitted a study to the FDA that found girls 11 to 16 years old are capable of following the directions for usage, according to the Wall Street Journal.
Watson Pharmaceuticals Inc., of Corona, Calif., makes a similar emergency contraceptive called Next Choice, which involves taking two levonorgestrel pills of lower dosage, either together or over a 24-hour period, according to the U.S. National Institutes of Health. Like Plan B, a customer's age determines whether Next Choice can be bought over the counter or by prescription.
Plan B was approved in 1999 as prescription-only. It wasn't until 2006 -- after much heated debate -- that the FDA eased the prescription requirement for older teens.
Plan B generated controversy in some quarters, including conservative political and religious groups. Wendy Wright, former president and CEO of Concerned Women for America, a political action group, cited safety issues associated with oral contraceptives and said young teens without medical supervision and parental awareness could face serious health risks.
Wright also argued that easing access would place a "huge burden" on pharmacists to provide patient counseling.
Safety issues concerning birth control pills have led the FDA to consider requiring new warning labels about increased risk of blood clots with newer forms of oral contraceptives. The concern centers around oral contraceptives such as Bayer's Yaz or Yasmin that contain a newer type of progestin hormone called drospirenone. A decision on the labeling may be made by Friday, the agency said this week.
For more about morning-after pills, visit the U.S. National Library of Medicine.
SOURCES: Dec. 7, 2011, news release, FDA Commissioner Margaret Hamburg, M.D.; Concerned Women for America website; Wall Street Journal
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