5-day 'MAP' gets FDA advisers' approval
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|Fri, 06-18-2010 - 3:08pm|
5-day 'morning after' pill gets FDA advisers' approval
By Elizabeth Landau, CNN
June 18, 2010 11:46 a.m. EDT
(CNN) -- An advisory panel of the U.S. Food and Drug Administration gave the green light Thursday to an emergency contraceptive for use up to five days after sex.
The Advisory Committee for Reproductive Health Drugs voted unanimously to recommend the drug, called ella.
The pill is intended for women who have had unprotected sex or for whom another method of contraception, such as a condom, failed.
Currently, there are no emergency contraception drugs available in the United States for use more than 72 hours after unprotected intercourse or failed contraception. The options available now -- Plan B, Plan B One Step and generic versions -- are available without a prescription to women 17 and older.
Two phase 3 clinical trials demonstrated that ella is effective and safe. One of the trials was done with women 18 and older in the United States; the other included women 16 and older in the United States, the United Kingdom and Ireland.
Researchers found that the pill was not as effective in heavier women, but the committee voted against a warning label on the drug for obese women, with a body mass index over 30.
The panel also advised against requiring women to have pregnancy testing before using the product.
Ella, manufactured by HRA Pharma, is a selective progesterone receptor modulator, meaning it binds to progesterone receptors in various tissues in the body. Progesterone is a hormone integral to the pregnancy process. This particular kind of drug has never before been approved as an emergency contraceptive.
The European Medicines Agency approved the marketing of this drug for use up to five days after sexual intercourse under the name ellaOne in May 2009.
Anti-abortion groups have criticized ellaOne, accusing it of being a means of obtaining an early abortion.
Concerned Women of America President Wendy Wright told the FDA advisory panel that ella is an abortion pill and that men could use it to exploit women by slipping it to their unknowing partners.
A group of 20 women's health organizations, including the American College of Obstetricians and Gynecologists, wrote a letter to the panel backing the drug, citing the roughly 3.1 million unintended pregnancies each year in the U.S.
"We do not believe technology holds all the answers, but having two types of safe and effective emergency contraception will increase the likelihood that a woman can access a product that works for her situation," the letter said.
The FDA often takes the advisory panel's recommendations but does not have an obligation to do so.