F.D.A. Approves 5-Day Emergency Contraceptive

By Gardiner Harris

WASHINGTON | AUG 14, 2010

Federal drug regulators on Friday approved a new form of emergency contraceptive pill that prevents pregnancies if taken as many as five days after unprotected intercourse.

The pill, called ella, will be available by prescription only. Developed in government laboratories, it is more effective than Plan B, the morning-after pill now available over the counter to women 17 and older.

That pill gradually loses efficacy and can be taken at most three days after sex. Ella, by contrast, works just as well on the fifth day as the first after sex.

Women who have unprotected intercourse have about 1 chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about 1 in 40, while those who take ella would cut that risk to about 1 in 50, regulators say. Studies show that ella is less effective in obese women.

The decision was greeted with enthusiasm by abortion rights groups and denounced by anti-abortion activists. But in recent years both sides have treated the emergency contraceptive pills as a side issue in the wider debate over abortion.

Studies have found that many women fail to realize they are at risk for an unplanned pregnancy after unprotected sex. So they tend not to use the emergency contraceptives even when they receive them free.

“Emergency contraception has no effect on pregnancy rates or abortion rates,” said Dr. James Trussell, director of the Office of Population Research at Princeton, who has consulted without charge for ella’s maker. “Women just don’t use them enough to make an impact.”

Still, the decision by the Food and Drug Administration to approve ella, less than two months after a federal advisory committee voted unanimously to recommend approval, marks a decided shift for the agency.

Under President George W. Bush, White House political advisers overruled united F.D.A. scientists, delaying the decision to make Plan B available over the counter and barring such distribution to women under 18.

Some advocates said Friday that the agency’s relatively rapid adoption of its scientists’ advice meant that its traditional separation from political considerations had returned.

“It’s really important the F.D.A. made a decision that’s based on the scientific evidence and not on the political controversy,” said Diana Zuckerman, president of the National Research Center for Women and Families.

But Wendy Wright, president of Concerned Women for America, which opposes abortion, said that political considerations were still at work inside the agency.

“The fact that the F.D.A. waited until late on a Friday night in August to release this when they hoped nobody was paying attention underscores that this is a political decision,” she said.

Ms. Wright warned that men might slip ella to unsuspecting women, and she said testing so far was not adequate to establish whether it was safe.

In studies, the most common side effects associated with ella’s use were mild to moderate headache, nausea, abdominal pain, painful menstrual cramps, fatigue and dizziness.

Ella’s approval may also intensify a long-simmering controversy about whether pharmacists and doctors can refuse to prescribe or fill prescriptions for birth control measures they find personally objectionable.

Much of the debate over the drug springs from an argument over how it works, which despite considerable research remains something of a mystery. It blocks the effects of progesterone, a female hormone that spurs ovulation. It is, however, a chemical relative to RU-486, the abortion pill, and there is some evidence that ella makes the womb less hospitable to a fertilized egg by reducing the lining of the uterus.

To the scientists on the advisory committee, whether the pill works by preventing ovulation or implantation was mostly immaterial to the decision about whether it is safe and effective. But to religious groups, the distinction is crucial, since they consider that preventing implantation of a fertilized egg is akin to abortion.

Animal studies showed that ella had little effect on established pregnancies, suggesting it acts differently from RU-486.

Ella, which was approved in Europe last fall, is manufactured by HRA Pharma, a small French drug maker. In the United States it will be distributed by Watson Pharmaceuticals, a company based in California and New Jersey, which plans to introduce it by the end of the year.

The pill was originally developed by the National Institute of Child Health and Human Development, part of the National Institutes of Health and now named after Eunice Kennedy Shriver. It decided in 2002 to finance a crucial study to assess the drug’s efficacy as an emergency contraceptive.

Studies have shown that more than one million women who do not want to get pregnant are estimated to have unprotected sex every night in the United States, and that more than 25,000 become pregnant every year after being sexually assaulted. Half of all pregnancies in the United States are unintended.