U.S. Health Secretary Says 'No' to Morning-After Pill for
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
"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
For more about morning-after pills, visit the
U.S. National Library of Medicine.
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