The FDA has approved the emergency contraceptive, ulipristal acetate, which has been sold in Europe as ellaOne and will be sold here with the brand name “ella.” The pill, which will be sold under presecription, is effective for up to five days after unprotected sex, and unlike Plan B, which is now available without a prescription to women over 17, and which is recommended for use up to three days after sex, keeps it potency over the entire five days.
Ella, manufactured by the French company HRA-Pharma, will be marketed in this country by Watson Pharmaceuticals and is expected to be available by the end of the year. It was approved for use in Europe last year, and is available in 22 countries. In June, the FDA advisory panel recommended approval by a vote of 11 to 0, saying that it proved effective and safe as an emergency contraceptive in pre-clinical and clinical trials.
Ella has been shown to reduce the risk of pregnancy by about two thirds. A woman having unprotected sex has a 1 in 20 chance of becoming pregnant. With Plan B, this is cut in half, to a 1 in 40 chance, and with ella this is cut further to 1 in 50. In those few cases where women have become pregnant after using ella, there have been no negative health effects.
But as with anything having to do with reproductive health, this is already controversial. Critics claim that the drug is not contraception, but rather an abortifactant. It works by interfering with the hormone progesterone, which stimulates ovulation. Conception cannot occur before ovulation. However, progesterone also helps prepare the uterus to receive a fertilized egg, and ella may also thin the interior uterus wall.
The Family Research Council, an anti-abortion group, is among the groups that have said they plan to launch a campaign advertising ella’s abortion potential. They claim that it is chemically similar to the abortion drug mifeprestone, or RU-486, which is approved for use up to 50 days after conception. RU-486 works by preventing fertilized eggs from implanting in the uterus, and also dislodging eggs recently implanted.
People speaking for the manufacturer say that it is quite different, and has only been tested and approved for use within five days of sex. It is intended as a way to prevent unwanted pregnancy, not to abort a fetus.
As for misuse of the drug, people misuse all sorts of things to induce abortion. It would be impossible to make all of them illegal. The best way to prevent such experimentation is to keep all approved forms of contraception as well as medical abortion legal and accessible. This is not acceptable to abortion foes, however, who increasingly are calling many forms of contraception abortifactants.
Both proponents and opponents of the approval of ella for use in the U. S. point to the difference in the approval process under this administration from the previous administration. The process, for example, for making Plan B available without a prescription, was delayed repeatedly by political opponents of abortion.
“Approval of ella is another indication that the FDA is committed to restoring scientific integrity in its decisions,” said Kirsten Moore, president of the advocacy group Reproductive Health Technologies Project.Opponents see this differently.”
“This decision flies in the face of the Obama administration’s promise to transparency and a commitment to science,” said Jeanne Monahan, a director at the Family Research Council. “The difference between preventing and destroying life is enormous, and women have the right to know how this drug will act on their bodies and on their babies.”
The difference in interpreting the science seems to depend on which data you use – the data from the actual research conducted on the drug, or the data of what might happen if the drug is misused. And as always, the issue seems to be one of defining the beginning of life.
No doubt the political controversy will continue. But in the meantime, another way to avoid unwanted pregnancy will become available to American women before the end of the year.