June 29, 2010

FDA ‘Ella’ Approval Faces Anti-Choice Pressure

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ellaOne (ulipristal acetate)(WOMENSENEWS)--U.S. pro-choice advocates are still worried about the drug "ella," which prevents pregnancy from occurring for five days after unprotected intercourse, rather than three, as the current available pills do.

The drug, which has been available as "ellaOne" in 22 European countries since October 2009, won unanimous backing from a U.S. Food and Drug Administration, FDA, advisory panel on June 17.

This brings it a step closer to U.S. availability, which could come as soon as the fall or winter of 2010.

In studies involving more than 4,500 women, ella prevented pregnancy up to 120 hours after unprotected intercourse. Research published in peer-reviewed journals, including The Lancet and Obstetrics and Gynecology, confirm that it is safe, with mild side effects--headaches, dizziness and nausea--experienced by only 5 to 10 percent of users.

Ella (also called ulipristal acetate), however, is sparking controversy because it is a close chemical relative of mifepristone, the medical abortion pill, known as RU-486, which has been available in the United States since 2000.

RU-486 works for up to nine weeks to prevent a fertilized egg from implanting in the womb or to dislodge a growing embryo.

Ella works by preventing ovulation. It's not an abortafacient--a substance that induces abortion--because it does not affect a fertilized egg or embryo. As a result, it doesn't terminate pregnancy as pregnancy is defined by the Washington-based American Congress of Obstetricians and Gynecologists, the Chicago-based American Medical Association and other health organizations.

Before the June 17 FDA ruling, 20 pro-choice groups--including Catholics for Choice, NARAL Pro-Choice America and the National Women's Law Center, all based in Washington--wrote a letter to the FDA in support of ella.

A Second Letter

Now, these organizations are preparing a second letter to the FDA that will once again stress women's need for a safe, long-lasting emergency contraceptive that prevents unwanted pregnancy.

"We need to get the word out and let people know what ella is, and what it isn't," said Kirsten Moore, president of Washington's Reproductive Health Technologies Project. Moore testified in support of ella at the June hearing.

On any given day, a million American women who do not want to become pregnant have unprotected sex and more than 25,000 women become pregnant every year after being sexually assaulted, report researchers from Princeton University in Princeton, N.J. As a result, notes the Atlanta-based Centers for Disease Control and Prevention, more than half of the pregnancies that occur in the United States every year are unintended.

Since 1999, women in the United States have had access to another form of emergency contraception: Plan B. Also called the "morning-after pill," the drug is made by the Israel-based Teva Pharmaceutical Industries.

While Plan B works for three days after unprotected intercourse, ella is effective for five. Those additional two days are significant because sperm can live in the female reproductive tract for up to five days, which means ella can prevent fertilization during the entire time that sperm are viable. The extra days are also significant because women who live in rural areas or who have other barriers to contraceptive access may not be able to obtain Plan B within its three-day window.

If approved, ella will be sold in the United States by Watson Pharmaceuticals, based in Corona, Calif.

While Plan B is available in the United States to women over age 17 without a prescription, ella would require a prescription for all women who take it. Though Plan B runs around $50, ella will likely cost $100 to $150.

"Plan B has a generic alternative, but ella does not," said Alina Salganicoff, vice president and director of women's health policy for the Menlo Park, Calif.-based Kaiser Family Foundation. "If you have prescription drug coverage, your policy will likely absorb the cost, but if you don't, you'll have to pay out of pocket."

Anti-Choice Advocates Speak Up

At the FDA hearing on ella, two of the 13 people who spoke to the committee were anti-choice advocates.

One of them was Wendy Wright, president of the Washington-based conservative group Concerned Women for America. She told the committee that ella "interferes with the lining of the uterus" and that the FDA should not "unleash" it on "unsuspecting women."

Cardinal Daniel N. DiNardo, chair of the U.S. Catholic bishops' Washington-based Committee on Pro-Life Activities, wrote the FDA and charged that ella could be slipped to women "by unscrupulous men with the intent of causing an early abortion without a woman's knowledge or consent."

Similar objections are echoed on the Web sites of anti-choice groups including the Washington-based LifeNews.com, Students for Life of America of Arlington, Va., and the Chicago-based Pro-Life Action League.

Ella's next step is for the same FDA administrators who oversaw the June 17 hearing to review the drug's application and respond to its maker's request for approval. Pro-choice advocates worry that the political opposition could lead to delays in this process, which typically takes at least several months.

Pro-Choice Activists' Concerns

When Plan B was under fire from anti-choice activists during the Bush administration, the FDA took more than three years to approve the drug.

"Under President Obama, the agency has taken steps to bring its handling of emergency contraception in line with the science," said Amy Allina, program director of the Washington-based National Women's Health Network. "But there is still an age restriction on over-the-counter distribution of Plan B despite medical community consensus that this is inappropriate and serves only to block timely access for young women. With that mixed record, we think it's an open question whether the agency will bring similar political concerns to its decision on this new emergency contraceptive."

Activists also worry about access to ella. Before Plan B finally became available as an over-the-counter drug in 1999, several anti-choice doctors and pharmacists refused to write or fill prescriptions for the drug when women asked them for it.

During the June 17 hearing, the FDA committee upset some pro-choice activists by asking whether there should be any restrictions placed on ella's sale--such as a recommendation that women take pregnancy tests before using the new drug.

"This requirement isn't made of other emergency contraceptives and we think it's unnecessary and potentially confusing," said Allina. "Pro-choice advocates breathed a sigh of relief during the hearing when the committee moved past that concern."

Molly M. Ginty (http://mollymaureenginty.wordpress.com) is a freelance writer based in New York City.

For more information:

Background on Ulipristal Acetate, Planned Parenthood:
http://www.plannedparenthood.org/files/PPFA/fact-ella-EC.pdf

"A New Option for Emergency Contraception: the Facts on Ulipristal Acetate," Reproductive Health Technologies Project:
http://www.rhtp.org/documents/EllaECFactSheet-UPDATEDRAFT6.7.10.pdf

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