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Posted at 9:57 AM ET, 12/ 1/2010

Controversial 'ella' contraceptive now available in U.S. for first time

By Rob Stein

A controversial new form of emergency contraception known as "ella" is now available to American women for the first time, the company selling the drug announced Wednesday.

Ella, which can prevent a pregnancy as many as five days after sex, can be obtained by U.S. women who get a prescription from a doctor, according to an announcement by Watson Pharmaceuticals Inc. of Morristown, N.J. The medication can even be obtained through an online pharmacy, the company said. The wholesale price will be $35.75.

The Food and Drug Administration approved ella in August. Ella was approved in Europe last year and was already available in at least 22 countries,

The decision to allow the sale of the pill was welcomed by family-planning proponents as a crucial new option to prevent unwanted pregnancies. But critics condemned the decision, arguing that it was misleading to approve ella as a contraceptive because the drug could also be used to induce an abortion.

"This is a deliberate effort to deceive women who would not otherwise take a drug that could harm their baby," said Wendy Wright of the group Concerned Women for America. "Providing the drug through a website means that anyone can buy it, any number of times. A predatory man who is sexually abusing a girl or wants force an abortion on a woman will be able to easily obtain this drug. This puts women at risk of men who can slip the drug into their food or drink. Without doctors' oversight, girls won't be tested for sexually transmitted diseases. When a woman experiences complications, the prescribing 'doctor' will be as anonymous as a drug dealer in a back alley."

Proponents have dismissed those concerns, saying there is no evidence the drug causes abortions, and welcomed the availability of the new option.

"Having another safe, effective method of birth control that can be used after sex to reduce the risk of pregnancy is always welcome news," said Kirstein Moore of the Reproductive Health Technologies Project.

Ella can cut the chances of becoming pregnant by about two-thirds for at least 120 hours after a contraceptive failure or unprotected sex, studies have shown. The only other emergency contraceptive on the market, the so-called morning-after pill sold as Plan B, becomes less effectual with each passing day and is much less effective after 72 hours.

Supporters and opponents both said the decision marked the clearest evidence of a shift in the influence of political ideology at the FDA. The last time the FDA considered an emergency contraceptive -- making Plan B available without a prescription -- the decision was mired in controversy amid similar concerns voiced by antiabortion activists. After repeated delays, Plan B was approved for sale to women 17 and older without a prescription.

If the history of Plan B is any indication, ella's approval is likely to mark the beginning of many years of political and regulatory battles over the drug. Critics are already concerned that ella's approval as a contraceptive will make it eligible to receive federal tax subsidies, which are banned for the abortion pill RU-486. They also are concerned that ella will be included in the services that health plans will have to pay for under the new health-care overhaul law.

Ella is also likely to exacerbate a long-running debate over whether doctors have an obligation to write prescriptions for medication they oppose on moral grounds and whether pharmacists have an obligation to fill them. Many doctors and pharmacists refuse to write or fill prescriptions for Plan B or refer patients elsewhere for it.

Plan B prevents a pregnancy by administering high doses of a hormone that mimics progesterone. It works primarily by inhibiting the ovaries from producing eggs. Critics argue that it can also prevent a fertilized egg from implanting in the womb, which some consider equivalent to abortion.

Known generically as ulipristal acetate, ella works as a contraceptive by blocking progesterone's activity, delaying the ovaries from producing an egg. But progesterone is also needed to prepare the womb to accept a fertilized egg and to nurture a developing embryo. That's how RU-486 prevents a fertilized egg from implanting and dislodges growing embryos. Ella's chemical similarity to RU-486 raises the possibility that it might do the same thing, perhaps if taken at elevated doses. But no one knows for sure whether the drug would induce an abortion, because the drug has never been tested that way.

Studies involving more than 4,500 women in the United States show ella is safe, causing only minor side effects, such as headaches, nausea, abdominal pain and dizziness, the FDA said.

By Rob Stein  | December 1, 2010; 9:57 AM ET
Categories:  Abortion, Contraception, FDA  
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Next: Babies on diets? Now I've heard it all.

Comments

Our friends on the religious right --- the folks who, like the Taliban, believe it is their god-given right to foist their religious beliefs on the rest of us --- will go nuts, but I for one will not listen to them any more.

How can a harmless pill that prevents pregnancy if taken within days of unprotected (or "magically" protected) sex be bad for anyone? Any woman should be able to buy this medication over the counter, as in Europe, at any time, no questions asked.

Really. It's nobody's business but their own.

Posted by: Casey1 | December 1, 2010 12:16 PM | Report abuse

I get that this is CWA, so logic need not apply, but "This is a deliberate effort to deceive women who would not otherwise take a drug that could harm their baby". Women who are looking to become pregnant will not go to their doctor and ask for a prescription for a pill that will prevent implementation. How on earth can CWA make the argument that women who are getting emergency contraception really want a pregnancy?!

Posted by: raheli | December 1, 2010 12:56 PM | Report abuse

Wendy Wright of the group Concerned Women for America...are you cuckoo? The drug will protect predatory males by aborting, rather than allowing to live to full term, the baby they created through the God-sanctioned act of rape? Really?

You need to hunker down on a church kneeler for a couple of hours and ask God to tell you the truth about what you say and do.

Posted by: HookedOnThePost | December 1, 2010 12:58 PM | Report abuse

Once again the battle of pro-choice and pro-life has surfaced. I have always been pro-choice. I believe that the bearer of the body must always have the right over it, be it a man or a woman. Nonetheless, I understand the concern of Wendy Wright on the availability of the pill online. There is great possibility of the scenarios she described. Since the U.S. is having this for the first time, I think the Government should be more responsible in dispensing it, even if they have talked to 4,500 women regarding its effects. It would also be helpful for critics and most importantly for the general public if the FDA would have researches that examined the effect of this pill to women in other countries, as it noted that these has been in Europe last year as well as in 22 other countries. This would help them in coming with an informed decision of whether to use or not use the pill.

Posted by: JenneferLyn | December 1, 2010 1:15 PM | Report abuse

If someone objects to Ella because it might prevent the implantation fertilized egg, then they can elect not to take it. I do not begrudge them their beliefs. That is why it is important to know how it works. This information (that Ella *may* have this effect) is readily available. No woman is being "fooled" unless they are fools who don't do the slightest bit of research into what they are taking. The onus is on them to read material readily available. I'm not sure how the predatory man comes into play - that's just plain weird.

As for me.... If it were an issue anymore, I'd keep a pack stashed in my medicine cabinet just in case.

Posted by: DCCubefarm | December 1, 2010 1:45 PM | Report abuse

This is crazy. They need to make a male contraceptive to use, in place of or in conjunction with condoms. Men don't have to mess with their hormones, and right now they can just blame it on the woman. Spread the risk and responsability around!

Posted by: gm123 | December 1, 2010 2:08 PM | Report abuse

Religious beliefs aside; there is a moment when two cells become a human being. I don't want to foist my beliefs on anyone, but when there is a UNIVERSAL TRUTH that a human being's life is at stake (and that human being is in the form of an embryo), I am certainly going to get up and say something about it.

Human life has value and dignity - even when it's just the size of the head of a pin.

Sometimes it takes debate like this one to educate people about what drugs do - not everyone has the time, capacity or interest to find out what ella does...but by having this public forum (online, in the news, etc.) more people will learn about the drug and that too will help!

Posted by: UpstateNewYorkerinDC | December 1, 2010 2:15 PM | Report abuse

"This is a deliberate effort to deceive women who would not otherwise take a drug that could harm their [BABY]," said Wendy Wright of the group Concerned Women for America."

To equate a block to POTENTIAL implantation to harming a "BABY" has to be the absolute pit of Biological Ignorance. Geeze!

Madness!

Posted by: lufrank1 | December 1, 2010 2:41 PM | Report abuse

Can you explain this headline to me? What is "controversial" about this other than that groups who feel they should monitor the uterus and vagina of every woman in this country make it so.

It is a contraceptive proven by science to be safe and effective. There is nothing much controversy to this other than what the far right wishes to make of it, and what the Washington Post participates in making so.

Jodi Jacobson
Editor in Chief
RH Reality Check

Posted by: jjacobson1 | December 1, 2010 2:57 PM | Report abuse

Posted by: UpstateNewYorkerinDC:

"Religious beliefs aside; there is a moment when two cells become a human being. I don't want to foist my beliefs on anyone, but when there is a UNIVERSAL TRUTH that a human being's life is at stake (and that human being is in the form of an embryo), I am certainly going to get up and say something about it.
Human life has value and dignity - even when it's just the size of the head of a pin."

&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&

Religious dogma aside, we are potential humans EVEN when we are one of the 400,000 primitive germ cells in an average human female's ovaries at birth (of course, more than 99% of them won't become actual human beings.

Just when a potential human being becomes an actual human being is actually unknown. Opinions (and they are no more than opinions) vary from the moment of fertilization to birth. [Actually, unfertilized eggs of several species have been parthenogenetically activated in laboratories.] For many the stage when the fetal brain becomes active is the moment of choice, as are various other stages.
THE Bottom Line is That No Matter What YOUR personal beliefs are - - - you do not HAVE to use any contraceptives/abortion drugs or procedures....BUT YOU HAVE ABSOLUTELY NO RIGHT TO IMPOSE YOUR PERSONAL BELIEFS on others!

"Your FREEDOM ends Where MY NOSE begins!

Posted by: lufrank1 | December 1, 2010 3:05 PM | Report abuse

Are any of the "critics" you mentioned in this article actually medical or public health professionals? I suspect they are not. There is no evidence to suggest ella would interrupt a pregnancy. Although there are chemical similarities to the chemicals used in medical abortions, a woman would have to take an extremely large quantity of ulipristal acetate for there to even be a possibility of interrupting a pregnancy. Since ella is expensive and available by prescription only, this would be awfully difficult for anyone to do.

I am disappointed a respected news source such as the Wasington Post would give so much weight to the scientifically baseless opinions of groups that have no genuine respect or concern for the health and well-being of women.

Posted by: jvanyur | December 2, 2010 1:07 PM | Report abuse

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Posted by: chuangjian2010 | December 6, 2010 2:18 PM | Report abuse

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