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FDA OKs Sale of 'Morning-After' Pill Without Age Limit
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THURSDAY, June 20 (HealthDay News) -- The so-called morning-after pill, an emergency contraceptive, is about to go over-the-counter, with the U.S. Food and Drug Administration announcing Thursday that it has approved unrestricted sales of Plan B One-Step.
The move follows a decision earlier this month by the Obama administration to drop its effort to fight a court order that would make the contraceptive pill available over-the-counter to all women and girls, regardless of age.
After fighting for an age threshold on the nonprescription use of the Plan B One-Step pill for months, the FDA said June 10 that it would heed the ruling of Judge Edward Korman, of the United States District Court for the Eastern District of New York. The drug prevents conception if taken within 72 hours of sexual intercourse.
Korman first issued his order April 5, igniting a battle over whether young girls could gain access to emergency contraception without a prescription. Soon after, on April 30, the FDA lowered to 15 the age at which people could purchase the Plan B One-Step pill over-the-counter -- two years younger than the prior age limit of 17.
A day later, on May 1, the Obama administration stepped in to appeal the Korman decision.
At the time of the FDA's move to lower the age limit, agency Commissioner Dr. Margaret Hamburg said that "research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.
"The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly and that it does not prevent the transmission of a sexually transmitted disease," she said.
Plan B prevents implantation of a fertilized egg in a woman's uterus through the use of levonorgestrel, a synthetic form of the hormone progesterone used for decades in birth control pills. Plan B contains 1.5 milligrams of levonorgestrel, more than the pill contains. It is considered a form of birth control, not abortion.
The Associated Press reported that the FDA's announcement Thursday only applied to Plan B One-Step. Other brands of emergency contraception include Next Choice and Ella.
Planned Parenthood has long pushed for wider access to emergency contraception. But conservative groups have objected to such a move.
-- E.J. Mundell
SOURCES: Planned Parenthood Federation of America, statement; Associated Press