According to the Post, FDA faced similar issues regarding the "distinction between preventing and terminating a pregnancy" when it vetted Plan B, another form of EC. Plan B prevents pregnancy for up to 72 hours after unprotected sex by administering a high dose of a hormone that mimics progesterone, which inhibits the ovaries from producing eggs. The agency eventually approved Plan B for sale without a prescription to women older than 17 amid criticism from antiabortion-rights supporters, who claim that the drug is the equivalent of an abortion.
Approved in Europe in 2009 and available in 22 countries, ella has been shown to prevent pregnancy after unprotected sex for up to 120 hours. Studies have indicated that the drug is nearly twice as effective as Plan B at preventing pregnancy, and its effectiveness remains constant for at least 120 hours. Plan B begins decreasing in effectiveness almost immediately and becomes ineffective after 72 hours, the Post reports.
However, ella's similar chemical composition makes it a close relative to mifepristone, which is used in medical abortions and can prevent a fertilized egg from implanting and can dislodge growing embryos. Critics of ella argue that the chemical similarity between the two drugs may lead women to use ella to abort a pregnancy. Wendy Wright of Concerned Women for America -- which opposed approval of Plan B -- said, "With ulipristal, women will be enticed to buy a poorly tested abortion drug, unaware of its medical risks, under the guise that it's a morning-after pill."
Advocates for ella argue that there is no evidence that ella works as anything other than a contraceptive. They also say that the drug has only been tested as an EC medication, not as an abortion drug (Stein, Washington Post, 6/11).
Paul Fine, medical director of Planned Parenthood of Houston and Southeast Texas, said that EC "is a woman's last chance to prevent an unintended pregnancy," noting that about half of all U.S. pregnancies are unintended. A clinical trial of ella conducted by Fine and his colleagues will be presented to the FDA panel (Rovner, "All Things Considered," NPR, 6/11).
Erin Gainer -- CEO of HRA Pharma, the French company that makes ella -- said that studies involving more than 4,500 women in the U.S. and Europe have shown ella to be highly safe, adding that the only side effects were headaches, nausea, fatigue and other minor conditions. Gainer said that there is "a great unmet need out there for [EC] that is as effective as this for so long." She also said that the company does not intend to test ella as an abortion drug, adding, "We're very clear on the fact that this is indeed a contraceptive -- a method of preventing pregnancy."
Advocates have said that they are concerned that the controversy surrounding ella might influence the FDA panel, noting the agency's repeated delays in approving Plan B. Susan Wood, an associate professor at the George Washington University School of Public Health and Health Services who resigned from FDA to protest delays regarding Plan B, said that the agency "should be a 'Just the facts ma'am' organization." She added, "I'm hoping the FDA will take that position."
Amy Allina, program director at the National Women's Health Network, said, "People who are opposing [ella] are not just opposed to abortion," adding, "They also opposed contraception and they are trying to confuse the issue" (Washington Post, 6/11).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.
© 2010 National Partnership for Women & Families. All rights reserved.
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