Debate to start about 'morning after' pill
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Supporters of the "morning after" pill say women need easy access to the pills after unprotected sex or when a condom breaks.
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WASHINGTON (Reuters) -- Making a "morning after" pill available without a prescription would provide more timely access to the emergency contraceptive, U.S. Food and Drug Administration staff said in a preliminary analysis.
A U.S. panel of scientific advisers will meet Tuesday to debate whether to recommend that the controversial pill be sold without a doctor's prescription for women to use shortly after intercourse to prevent pregnancy.
Women's Capital Corp. has asked regulators for permission to sell its emergency contraceptive called Plan B over the counter. Supporters say women need easy access to the pills after unprotected sex or when a condom breaks.
Emergency contraceptives can prevent pregnancy if taken within 72 hours after having sex.
Opponents worry women will rely on Plan B instead of regular contraception, and some view use of the emergency pills as equivalent to an abortion.
The FDA advisers will hear presentations from agency staff, the manufacturer, as well as comments from the public, before making a recommendation on the possible switch to nonprescription status.
The FDA will consider the panel's advice before making a final decision. The agency usually follows its panels' recommendations.
Adolescent accessibility
Forty-four members of Congress wrote to the FDA last week urging it to reject the over-the-counter request, saying it would make Plan B "as accessible to our nation's teenage daughters as aspirin or hairspray."
A review by FDA staffers, posted on the Internet on Monday, found Plan B had an acceptable margin of safety and posed no clear danger to a fetus if a woman was already pregnant.
"Because emergency contraception is more effective in preventing pregnancy the earlier it is taken after unprotected sexual intercourse, over-the-counter status should enhance benefit by providing more timely access to the product than through prescription," said the FDA staff review at: http://www.fda.gov/ohrms/dockets/ac/03/briefing/4015b1.htm.
The FDA staffers did recommend labels warning women not to take Plan B if allergic to the hormone it contains and a warning to see a doctor if severe stomach pain is experienced, a possible warning of a pregnancy outside the uterus.
"Emergency contraception is safe and effective and is the best way to prevent unintended pregnancy in cases of contraceptive failure," Vanessa Cullins, a Planned Parenthood official who will testify before the panel, said in a statement.
Catholic bishops weigh in
Plan B contains high doses of progestin, one of the hormones used in birth control pills, to interfere with ovulation or prevent fertilization of an egg, according to the manufacturer.
But some research has suggested the pills also stop a fertilized egg from implanting in a woman's uterus, which upsets some abortion opponents.
"The drug regimen under consideration can act as an abortifacient ... therefore it is unsafe and may be toxic to developing human embryos," the U.S. Conference of Catholic Bishops wrote in comments to the FDA.
Barr Laboratories Inc. has an agreement to acquire Plan B from privately held Women's Capital Corp.
Emergency contraceptive pills are different than the RU-486 abortion pill, which is FDA-approved for use within 49 days after a woman's last menstrual period for terminating pregnancy.
Copyright 2003
Reuters. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
