Victory for Emergency Contraception
Date:
Tue, June 29, 2010
On June 17, 2010, new strides were made in reproductive health choices. The FDA Reproductive Health Drugs Advisory Committee recommended FDA move quickly to approve ulipristal acetate, marketed under the brand name ellaOne, as a safe and effective emergency contraceptive (EC) product in the U.S.
If formally approved, ellaOne will join Plan B (levonorgestrel) and its generic Next Step as the only products available for the use of emergency contraception in this country. Unlike its predecessors, ellaOne will only be available by prescription from a healthcare provider. One of the differences between ellaOne and Plan B is that ellaOne can be taken up to five days (120 hours) of unprotected sexual intercourse or suspected failure of contraceptive method. While Plan B is found effective when taken within 72 hours (losing effectiveness with each passing day), ellaOne may be a more favorable option for women seeking emergency contraception. Clinical studies have found that ellaOne has the same efficacy in preventing pregnancy, whether on the first day or fifth day after the sexual activity.
I had the wonderful opportunity to attend the FDA advisory meeting in person and witness the testimony and discussion of scientific evidence from the clinical trials. During the public comment period, there were many representatives from various organizations and agencies that showed support for the approval of ellaOne and cited reasons such as another option for EC and a longer window of time to obtain the medication to prevent a pregnancy. But along with the many advocates for ellaOne, there were a handful of anti-choice activists in attendance as well. Although only a couple of these individuals presented their thoughts during the public comment period, it quickly became apparent that the anti-choice movement will once again try to construe the intended use of the drug as an abortifacient.
EllaOne, along with Plan B, is not an abortion pill. Period. The abortion pill RU-486, generically known as Mifepristone, is used in combination with another medication, a synthetic prostaglandin called misoprostol. Mifepristone blocks the action of progesterone, while misoprostol causes the uterus to contract, and helps the pregnancy tissue to expel. Ulipristal acetate (ellaOne) emergency contraception works primarily by delaying ovulation. Emergency contraception, whether it’s Plan B or ellaOne, cannot terminate an existing pregnancy.
The fictitious and partiality of the anti-choice activists’ messages about emergency contraception provides many arguments, but fail to offer any solutions to the true issues at hand. The reality is contraception is imperfect and so is human behavior. Our birth control method may fail or we may forget to take our pill or change our patch, or the condom we are using slips off or breaks. And what about women who are victims of sexual assault? Would it be justly to bar these victims from seeking options to prevent a possible pregnancy that may have resulted from that assault? In actuality, an emergency conception method that is effective for up to five days could prove very beneficial. Having that extra 48 hours could alleviate a woman in considering this option, locating the nearest facility to obtain the medication, acquiring the necessary transportation, and finding the means to pay for the pill. Although Plan B is still a great alternative, it is still necessary to have another option that may accommodate women who wish to prevent a pregnancy, but will be unable to retrieve the EC within 72 hours. It is important to note that both Plan B and ellaOne are intended to be used as soon as the unprotected sexual intercourse has occurred. However, having that window of time to seek this medication is also crucial and necessary.
Kudos to the FDA advisory committee for taking into consideration the clinical trials and scientific evidence regarding the use of ellaOne. Hopefully, the FDA follows the advice of the committee and approves this emergency contraception drug to be available at healthcare providers and clinics nationwide.
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