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

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. […]

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. […]

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.

Read the entire article here.