Controversial 'ella' contraceptive now available in U.S. for first time
A controversial new form of emergency contraception known as "ella" is now available to American women for the first time, the company selling the drug announced Wednesday.
Ella, which can prevent a pregnancy as many as five days after sex, can be obtained by U.S. women who get a prescription from a doctor, according to an announcement by Watson Pharmaceuticals Inc. of Morristown, N.J. The medication can even be obtained through an online pharmacy, the company said. The wholesale price will be $35.75.
The Food and Drug Administration approved ella in August. Ella was approved in Europe last year and was already available in at least 22 countries,
The decision to allow the sale of the pill was welcomed by family-planning proponents as a crucial new option to prevent unwanted pregnancies. But critics condemned the decision, arguing that it was misleading to approve ella as a contraceptive because the drug could also be used to induce an abortion.
"This is a deliberate effort to deceive women who would not otherwise take a drug that could harm their baby," said Wendy Wright of the group Concerned Women for America. "Providing the drug through a website means that anyone can buy it, any number of times. A predatory man who is sexually abusing a girl or wants force an abortion on a woman will be able to easily obtain this drug. This puts women at risk of men who can slip the drug into their food or drink. Without doctors' oversight, girls won't be tested for sexually transmitted diseases. When a woman experiences complications, the prescribing 'doctor' will be as anonymous as a drug dealer in a back alley."
Proponents have dismissed those concerns, saying there is no evidence the drug causes abortions, and welcomed the availability of the new option.
"Having another safe, effective method of birth control that can be used after sex to reduce the risk of pregnancy is always welcome news," said Kirstein Moore of the Reproductive Health Technologies Project.
Ella can cut the chances of becoming pregnant by about two-thirds for at least 120 hours after a contraceptive failure or unprotected sex, studies have shown. The only other emergency contraceptive on the market, the so-called morning-after pill sold as Plan B, becomes less effectual with each passing day and is much less effective after 72 hours.
Supporters and opponents both said the decision marked the clearest evidence of a shift in the influence of political ideology at the FDA. The last time the FDA considered an emergency contraceptive -- making Plan B available without a prescription -- the decision was mired in controversy amid similar concerns voiced by antiabortion activists. After repeated delays, Plan B was approved for sale to women 17 and older without a prescription.
If the history of Plan B is any indication, ella's approval is likely to mark the beginning of many years of political and regulatory battles over the drug. Critics are already concerned that ella's approval as a contraceptive will make it eligible to receive federal tax subsidies, which are banned for the abortion pill RU-486. They also are concerned that ella will be included in the services that health plans will have to pay for under the new health-care overhaul law.
Ella is also likely to exacerbate a long-running debate over whether doctors have an obligation to write prescriptions for medication they oppose on moral grounds and whether pharmacists have an obligation to fill them. Many doctors and pharmacists refuse to write or fill prescriptions for Plan B or refer patients elsewhere for it.
Plan B prevents a pregnancy by administering high doses of a hormone that mimics progesterone. It works primarily by inhibiting the ovaries from producing eggs. Critics argue that it can also prevent a fertilized egg from implanting in the womb, which some consider equivalent to abortion.
Known generically as ulipristal acetate, ella works as a contraceptive by blocking progesterone's activity, delaying the ovaries from producing an egg. But progesterone is also needed to prepare the womb to accept a fertilized egg and to nurture a developing embryo. That's how RU-486 prevents a fertilized egg from implanting and dislodges growing embryos. Ella's chemical similarity to RU-486 raises the possibility that it might do the same thing, perhaps if taken at elevated doses. But no one knows for sure whether the drug would induce an abortion, because the drug has never been tested that way.
Studies involving more than 4,500 women in the United States show ella is safe, causing only minor side effects, such as headaches, nausea, abdominal pain and dizziness, the FDA said.
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