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Controversial 'Days-After' Contraceptive Pill Approved by FDA

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By Admin on August 17, 2010 11:35 AM

Not only do women have a Plan B, now there is a plan C as well. The FDA has approved a contraceptive pill manufactured by Watson Pharmaceuticals Inc. which will be a contraceptive that women can take up to five days after sex. The pill's actual name is Ella (chemical name, ulipristal) and it will be on the market as of late this year. Unlike Plan B, the new drug will require a prescription.

The drug has been controversial, according to Bloomberg News. Anti-abortion groups have opposed its approval saying that the drug is similar in its chemical make-up to the so-called abortion pill, RU-486. However, a FDA panel of advisers voted unanimously for the drug's approval in June of this year. The panel found Ella to be safe and did not find the drug was capable of terminating an existing pregnancy.

According to a statement by Fred Wilkinson, the Watson Pharmaceuticals executive vice president for global brands, the drug is efficacious. Studies show the drug lowered the pregnancy rate to 2.2 percent among women who took it 48 to 120 hours after unprotected sex. The expected pregnancy rate is 5.5 percent.

Bloomberg reports that both Plan B and Ella work by stalling ovulation. Ella delays that process as much as five days, a key because sperm can live that long inside the body, Jeffrey Jensen, a professor at Oregon Health & Science University, said in a June 2 interview.

The Family Research Council, a Washington-based advocacy group, disagreed with the decision, saying the FDA should have required further study before approving it. “Approval of Ella raises concerns about taxpayer funding of abortions since currently the U.S. government will pay for emergency contraception, but not abortion pills,” Jeanne Monahan, director of the Council’s Center for Human Dignity, said today in a statement.

Watson will release information on Ella’s price and the company’s marketing plans when it begins selling the contraceptive pill drug later this year, Watson spokesman Charlie Mayr said in a telephone interview with Bloomberg.


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