FDA OKs Sale of 'Morning-After' Pill Without Age Limit

Girls of all ages will now have easier access to the emergency contraceptive

By EJ Mundell

HealthDay Reporter

THURSDAY, June 20 (HealthDay News) -- The so-called morning-after pill 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 emergency 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.

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U.S. Ends Effort to Limit Access to 'Morning-After' Pill

FDA will heed court order mandating that women, girls of all ages have over-the-counter access

By EJ Mundell

HealthDay Reporter

TUESDAY, June 11 (HealthDay News) -- The U.S. government has dropped its effort to block a court order that would make the morning-after contraceptive pill available over-the-counter to all women and girls.

After fighting for an age threshold on the nonprescription use of the Plan B One-Step pill for months, the U.S. Food and Drug Administration said in a statement late Monday 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 having sexual intercourse.

The Obama administration appears to have concluded that it could lose its case, and would have to weigh whether to request that the Supreme Court hear any appeal, the New York Times reported.

Women's reproductive rights groups, which had sued the government to clear the way for broader distribution of the drug were happy with the decision, the Times reported, but they still wanted to see the details of how the change would be implemented.

"We will not rest in this fight until the morning-after pill is made available without delay and obstruction," said Mara Verheyden-Hilliard, executive director of the Partnership for Civil Justice Fund, which represented the plaintiffs in the case, the newspaper reported.

"This is a huge breakthrough for access to birth control and a historic moment for women's health and equity," Planned Parenthood President Cecile Richards said in a news release. "The FDA's decision will make emergency contraception available on store shelves, just like condoms, and women of all ages will be able to get it quickly in order to prevent unintended pregnancy."

However, the decision is certain to anger abortion rights opponents, who oppose allowing young girls access to the drug without the consent or involvement of a parent or a doctor.

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 U.S. Food and Drug Administration 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 in a news release 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," Hamburg said.

View the original article here