FDA Should Act Quickly to Approve New Emergency Contraceptive

Alicia Johnson

The FDA is considering approval of a new pregnancy prevention option.  Anti-choicers are, unsurprisingly, opposing approval of and expanded access to the method.

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. 

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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.

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