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.

"This is great news [because] the need for emergency contraception is so great," Streicher said, pointing out that 50 percent of pregnancies are unplanned. Among those, she said, half involve couples using contraceptives that either malfunctioned -- like a condom breaking -- or were insufficient, like a diaphragm used without spermicidal foam.

"People often think unplanned pregnancies are [the consequence of] people being irresponsible, but that's not [usually] the case. It's often from a failed attempt at contraception -- that's why it's so important that we have emergency contraception."

Streicher says the longer window for taking ellaOne fills a much-needed gap in reproductive health because those who most often have unwanted pregnancies -- teenagers and those without access to adequate gynelogical care -- cannot always get to a doctor for treatment within a day or two.

While teens 17 and older can get Plan B over-the-counter, those under 17 would need to see a doctor, and it is these girls that may be most affected by a three-day time limit on the existing emergency contraceptive pills, Streicher says.

"In a perfect world you want anyone to use emergency contraception within 24 hours, but the reality is that having this five-day option is going to decrease the number of undesired pregnancies," she said.

Emergency Contraception -- A False Sense of Reproductive Security?

But this more powerful form of emergency contraception raises several concerns for anti-abortion rights advocates.

Harrison said that unlike Plan B, ellaOne is chemically similar to the common abortion pill RU-486, which is taken to abort a fetus as late as two months into pregnancy.

She believes that ellaOne is likely to carry the same risks as RU-486, such as excessive bleeding and infection, and said her biggest concern is the often overlooked risks this new drug could pose to the women who take it.

Harrison cites one study of Plan B, currently available over-the-counter, in which more than half the women who participated didn't know how to use the pill correctly. Incorrect use can lead in a failure of the drug and/or adverse side effects.

Harrison fears that if ellaOne were to be brought to the states as another over-the-counter option, the chance for misuse and adverse side effects would be high.

If the FDA approves ellaOne for use in the states, however, it will be given only through a doctor, not over-the-counter.What's more, in a recent study on the drug, the only serious adverse event researchers found with ellaOne was dizziness, and this only occurred in one subject.

Another concern among pro-life critics of the drug is the fear that it will give women a sense of false security, leading them to be more lax about using contraception or practicing abstinence.

"Habits follow technology. Contraception was supposed to prevent an abortion, but it has led to an increase in abortion when people got used to it being around. The increased effectiveness of technology [like this] means people will relax that much more on their inhibitions," said Stephen Phelan, communications manager for Human Life International, an anti-abortion missionary organization.

But Streicher countered that in her twenty years of experience, and in the literature on the topic, this fear is unfounded.

"Emergency contraception does not increase the chance that someone is going to not use contraception or that someone is going to start sexual activity at an earlier age. On the contrary, it is necessary option for women who have that rare contraception failure or...even more importantly, for those who are raped."