FDA Panel to Decide on U.S. Distribution of Controversial Contraceptive Pill, EllaOne

Jun. 16, 2010— -- A controversial, longer-lasting morning after pill has received the unanimous backing of a Food and Drug Administration panel of experts.

The panel today recommended that ellaOne, a one-pill treatment that has proved effective in preventing pregnancy up to five days after unprotected intercourse, be approved for use in the United States. Although the FDA is not required to follow the panel's recommendation, it usually does.

EllaOne, made by French drugmaker HRA Pharma, was approved for use in Europe last year, but discussion of selling it in the U.S. has spurred controversy as critics of the drug say that it is not so much emergency contraception as emergency abortion.

"This is a thinly veiled attempt to get an abortion drug over-the-counter," said Dr. Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists.

Because fertilization of egg and sperm can only be prevented within 24 hours of intercourse if the woman has just ovulated, Harrison argues, any emergency contraceptive that is effective five days after sex most likely works by preventing the already-fertilized egg from implanting in the uterus. If one believes pregnancy begins with fertilization, that action would be considered abortion.

"To label this as emergency contraception when it's clearly an abortive action is dishonest," said Harrison.

But according to Dr. Lauren Streicher, clinical instructor in obstetrics and gynecology at Northwestern Medical School, believing that emergency contraception is equivalent to an abortion "is a big misconception."

It takes five to seven days for the fertilized egg to implant in the uterus and begin to grow, she says. She argues that if one interrupts the process before this implantation takes place, pregnancy never occurs.

"There are many people who are reluctant to take emergency contraception because they think it's abortive, but it's apples and oranges," she said. "With emergency contraception, it's really to stop a pregnancy from occurring."

Not surprisingly, these differing opinions hinge on the same definitional controversy that has plagued the abortion debates for decades: at what point does pregnancy begin -- when the egg is fertilized, or when it implants in the uterus?

Because these two events can occur up to a week apart, emergency contraceptives, especially ellaOne with its five-day window for use, walk the line in this controversy.

New Drug Revives Old Debates

Available by prescription in Europe since September, ellaOne is 50 percent more effective -- and effective for 48 hours longer -- than the "morning-after pill" or Plan B, according to new research recently in the Lancet.

In the study of nearly 1,700 women between the ages of 16 and 36 who sought emergency contraception, women who took a morning-after pill had a 2.6 percent chance of becoming pregnant, while women who took ellaOne had only a 1.8 percent chance, and a five-day window of opportunity to take the pill.

Researchers noted that all forms of emergency contraception are more effective the sooner after intercourse they are taken, but ellaOne was found to be even more effective -- two thirds more -- than Plan B when taken within 24 hours of intercourse.

For those who support the use of emergency contraceptives, ellaOne is considered an important and vital innovation that will provide more reliable pregnancy prevention.