The day-after pill on the market soon?
An advisory committee to the U.S. Food and Drug Authority, the FDA has recommended Thursday the U.S. market launch of a new pill "the day after," already available in Europe, which is likely to reopen the debate on abortion.
Unanimously, the eleven experts from the FDA felt that the pill "Ella" the laboratory HRA Pharma, which terminates a pregnancy up to five days (120 hours) after sex, was effective and showed good tolerance. The opinion is advisory and not binding on the FDA; however, which generally follows the recommendations these experts. "We are pleased that the Committee has been able to confirm the effectiveness of our product. We are optimistic "about the green light from the FDA, told AFP the young American HRA boss, Erin Gainer.
The final decision from the FDA is expected in a few months and hope HRA commercialization "at the end of the year," via a U.S. partner, Watson Pharmaceuticals. If it is positive, "Ella" will be distributed in Europe as a prescription.
This sector competes with the morning-after pill Plan B and Next Choice generic, HRA; whose turnover was 36.5 million euros, hopes to market "hundreds of millions of dollars," said Ms. Gainer? The license of the molecule, invented in the United States, was acquired by the lab that has developed its first clinical application.
The extension of the deadline for emergency contraception (five days instead of three days to "Plan B" available without a prescription) stir up controversy from anti-abortion, sometimes violent in the United States. They liken the effect of the new abortion pill rather than a contraceptive.
As a precaution, two police officers were responsible for ensuring the public meeting in a hotel in suburban Washington, where debate's doctors were uneventful.
"The most common side effects were nausea, headache, abdominal pain and menstrual, fatigue and dizziness," experts said the FDA, based on studies of more than 4700 women.
The chemical composition of the "Ella," which prevents ovulation is close to the abortion pill RU-486 can terminate a pregnancy up to nine weeks after intercourse. RU-486, which was introduced 10 years ago in the United States, had aroused the opposition of anti-abortion?
"The elephant is in the room, that is to say, the question everyone asks is whether this drug causes a kind of abortion," asked one medical consultant FDA.
"This drug is not for use when you're already pregnant," said the boss of HRA Pharma. FDA experts have also raised many questions about its effectiveness, apparently lesser among overweight women.
A dozen organizations to help women intervened before the experts, most of them recommending the placing on the market of "Ella."
"The United States has one of the highest teenage pregnancy's strongest industrialized countries. This rate is six times taller than in a the Netherlands, in Germany four times and three times higher, "noted Sarak Audelo, head of Advocates for Youth.
Among the opponents, Wendy Wright, president of the organization Concerned Women for America (CWA), compared the new pill RU-486, citing seven deaths that accompanied the placing on the market.
Alerts: If you want to know more fresh update helpful articles enter your email address below and be notified by mail.
