FDA Should Act Quickly to Approve New Emergency Contraceptive


Today the Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs will meet to advise the FDA on the approval of a new emergency contraceptive, ulipristal acetate 30 mg, also known as “ella” in the United States. It has been available under the brand name ellaOne® in Europe since May 2009 after approval from the European Medicines Agency and is now available in more than 20 countries.  Clinical trial data has shown ella to be safe and effective at reducing the risk of pregnancy up to five days (120 hours) after unprotected intercourse or contraceptive failure. This is two days more than other products on the market, providing women an even longer window to prevent pregnancy after unprotected sex.

As a reproductive health advocate, I am excited for the opportunity to expand safe and effective pregnancy prevention options for women. Half of all pregnancies in the United States are unplanned. While there are many birth control options to choose from, sometimes a woman needs a backup method – a condom breaks or she forgets to take her pill. There are also cases when sex is unplanned, or unfortunately, unwanted. Emergency contraception is an important tool for a woman to tailor family planning for her particular circumstances.

Ella is a welcome addition to the contraceptive family for two key reasons. First, it may be a more affordable EC option. If a woman’s insurance doesn’t cover over-the-counter EC, the availability of ella, which if approved will be a prescription-only product, may help her utilize EC in the event she needs it. Second, because ella remains effective for five days, its availability will increase access for women who need additional time to obtain the product.

Unfortunately, recent media coverage has highlighted how opponents of ella are working to demonize this safe, effective and necessary contraceptive option out of the gate, leading again to the unnecessary politicization of women’s reproductive health. Opponents are predictably rehashing the same, tired arguments against emergency contraception used in the past, attempting to create confusion and doubt about this product. While chemically related to mifepristone, there is no evidence that ulipristal acetate 30 mg can cause an abortion. Women seeking to end a pregnancy should use one of the other safe, legal FDA approved options. Other sources, including Feministing and Salon’s Broadsheet, have highlighted the potential of ella for women’s health. 

In written and oral testimony this Thursday, women’s reproductive health organizations will urge the FDA to approve this important new EC option.  We will remind the FDA Advisory Committee of the importance of expanding safe and effective pregnancy prevention options for women, and the significance of the increased window of time ella provides for a woman seeking to prevent pregnancy after contraceptive failure or unprotected intercourse. A woman is healthiest when she can decide the timing and spacing of her pregnancies.  Let’s ensure that women have access to the most safe and effective options for preventing pregnancy.

For more information on ella, check out the comprehensive fact sheets released by Reproductive Health Technologies Project and Planned Parenthood.

Like this story? Your $10 tax-deductible contribution helps support our research, reporting, and analysis.

To schedule an interview with contact director of communications Rachel Perrone at rachel@rhrealitycheck.org.

  • triptrain

    My only concern with Ella is that there are “extremely limited data” available regarding whether or not it may impact an existing pregnancy or affect the resulting pregnancy in case of failure.* (I assume this is why it’ll be available by prescription only – to rule out the possibility of an existing pregnancy before offering it.) I’m a little dumbfounded by the fact that they haven’t bothered to study this.

     

    I have taken Plan B twice in my life – once after being assaulted, and once after a birth control failure (Nuvaring fell out while I was showering and it went unnoticed). In both of those cases, I was 99%+ sure that I’d abort if I became pregnant. I would have loved to have Ella available, and I would have used it if it were (assuming I could’ve afforded it). Still, I can understand why a woman in a different situation might want to make sure that whatever she takes has no chance of causing a miscarriage or birth defects.

     

    * Found here: http://www.ema.europa.eu/humandocs/PDFs/EPAR/ellaone/H-1027-en6.pdf

  • crowepps

    My only concern with Ella is that there are “extremely limited data” available regarding whether or not it may impact an existing pregnancy or affect the resulting pregnancy in case of failure.* … I’m a little dumbfounded by the fact that they haven’t bothered to study this.

    What protocol would you suggest?  Perhaps get a group of women who are pregnant and give them the drug just to see what happens?  You see the problem with that?  It seems sensible to me to give the women a pregnancy test to see whether there is an established pregnancy and prescribe them the drug if there is not.  Most women do not agonize tremendously over zygotes (with a few notable exceptions such as Paul) and if the occasional zygote fails to implant in a woman who doesn’t WANT to be pregnant anyway, that probably won’t seem tragic to most people, particularly when they WILL NEVER KNOW IT HAPPENED.

  • triptrain

    What protocol would you suggest?  Perhaps get a group of women who are pregnant and give them the drug just to see what happens?  You see the problem with that?

     

    I most certainly DO see the problem with that – but obviously we have found a way to study this, or the makers of Plan B wouldn’t be able to guarantee that their product does not affect existing pregnancies. Since they make that claim, I assume they’ve backed it up with research – so why can’t Ella?

     

    It seems sensible to me to give the women a pregnancy test to see whether there is an established pregnancy and prescribe them the drug if there is not.  Most women do not agonize tremendously over zygotes (with a few notable exceptions such as Paul) and if the occasional zygote fails to implant in a woman who doesn’t WANT to be pregnant anyway, that probably won’t seem tragic to most people, particularly when they WILL NEVER KNOW IT HAPPENED.

     

    I wouldn’t lose sleep over the death of a zygote, especially since 60-80% of them never implant even under totally natural conditions. But it’s not my place to say that another woman shouldn’t be bothered by it, so frankly, I think she deserves to know whether or not it’s a possibility. “She’ll never know, so what’s the harm?” doesn’t cut it for me.

    What bothers me more is the unexplored possibility of birth defects, since not everyone aborts after an EC failure. Surely they could do follow-up studies of the women for whom Ella failed.

  • crowepps

    What bothers me more is the unexplored possibility of birth defects, since not everyone aborts after an EC failure. Surely they could do follow-up studies of the women for whom Ella failed.

    They did do follow-up studies of the women for whom EllaOne failed in Europe.

    Of the 29 women studied who became pregnant despite taking ulipristal acetate, 16 had induced abortions, six had spontaneous abortions, six continued the pregnancies, and one “was lost to follow-up”

     

    http://en.wikipedia.org/wiki/Ulipristal_acetate

    That is such a small sample, only six completed prenancies, that I wouldn’t think any useful information would result.

     

    There is a fact sheet available here:

     

    http://www.rhtp.org/contraception/emergency/documents/EllaECFactSheet-UPDATEDRAFT6.7.10.pdf

     

    They ALWAYS do follow-up on every drug. Doctors are required to report any adverse side-effect even in drugs that have been on the market for a long time.

     

    I was particularly interested in the fact that this drug in another formulation has been found to be effective in treating uterine fibroids, one of the most common reasons for hysterectomy.

    The protocol was a follow-on to the recently-published Phase IIa trial which demonstrated in a placebo-controlled design that ulipristal acetate is effective in rapidly controlling bleeding and reducing fibroid volume in women with symptomatic uterine fibroids (Obstet & Gynecol2008;111(5):1129-36).

     

    http://www.sofinnova.fr/hra-pharma-and-preglem-announce-successful-news-866.php

  • triptrain

    Thanks for the info! Yes, six women is far too small a sample size to draw any solid conclusions from. I wonder if they’ve done any animal studies on the impact of Ella on pregnancy?

     

    I was particularly interested in the fact that this drug in another formulation has been found to be effective in treating uterine fibroids, one of the most common reasons for hysterectomy.

     

    I’d never heard of uterine fibroids. It seems like every day I learn about a new threat to my reproductive system. Bah.