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"Morning after pill" approved; teen access is next battle
The Associated Press
WASHINGTON — It's the morning after, and the controversy over nonprescription sales of the emergency contraceptive Plan B hasn't abated.
By year's end, women 18 and older who want to use the so-called "morning-after pill" will be able to buy it from licensed pharmacies without having to visit a doctor. Adult men, too, will be able to buy the contraceptive for their partners.
Girls 17 and younger will need a prescription, the Food and Drug Administration (FDA) said Thursday in deciding on an application that Barr Pharmaceuticals filed in 2003 for the product.
Barr, some lawmakers and doctor's groups said they will press the government to give minors the right to purchase Plan B over the counter. That could help halve the nation's 3 million annual unplanned pregnancies, they said.
Plan B is actually two pills containing a synthetic version of the hormone progestin used in standard birth-control pills. If a woman takes Plan B within 72 hours of unprotected sex, she can lower the risk of pregnancy by up to 89 percent. Plan B is not an abortion pill. If a woman is pregnant, it will have no effect.
The approval marks the first time a hormonal contraceptive will be broadly available in the United States without a prescription.
The announcement was aimed at resolving one of the longest, highest-profile health controversies of the Bush administration, but opponents said they were considering trying to block the decision, either in court or in Congress.
Plan B versus abortion pills
The "morning-after pill," also called emergency contraception, prevents pregnancy but has no effect if a woman is pregnant. Sold under the brand name Plan B, the two-pill series is a higher-than-normal dose of a hormone found in regular birth-control pills. It works by preventing ovulation or fertilization of an egg. While it may prevent the egg from implanting in the uterus, the medical definition of pregnancy, recent research suggests that's not likely.
The abortion pill, RU-486 or Mifeprex, can terminate pregnancy up to 49 days after the beginning of the last menstrual cycle. It's a two-pill process. First, a woman swallows Mifeprex, which blocks production of a hormone required to sustain pregnancy. Then she takes a second medicine, misoprostol, to cause contractions and finish the abortion.
The Associated Press
"This decision has nothing to do with science or FDA rules but has everything to do with politics," said Sen. Tom Coburn, R-Okla.
Coburn and other social conservatives said the high doses of hormones in the pills carry risks, and making them more easily available will encourage sexual activity and result in more unwanted pregnancies and sexually transmitted diseases.
"If the FDA thinks that enacting an age restriction will work, or that the drug company will enforce it ... then they are living in a dream world," said Wendy Wright, president of Concerned Women for America, which led the opposition.
Women's-health and family-planning advocates hailed the decision as a long-overdue milestone that will make it much easier for women to prevent unwanted pregnancy when they have unprotected sex or when other contraception, such as a condom, fails. It will be particularly valuable to rape victims, they said.
But the Planned Parenthood Federation of America said it was troubled by "the scientifically baseless restriction imposed on teenagers."
"Anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy," said the group's president, Cecile Richards.
The FDA's decision also means the agency may gain a permanent leader, something it has done without for all but 18 months since President Bush took office in 2001.
Sen. Patty Murray, D-Wash., and Sen. Hillary Clinton, D-N.Y., had blocked Dr. Andrew von Eschenbach's confirmation as FDA commissioner until the agency decided on Plan B. On Thursday, the lawmakers said they would lift their hold. Von Eschenbach could be confirmed as early as next month.
Anti-abortion groups, angered by the expected approval, urged Bush to dump von Eschenbach. Bush said Monday he supported von Eschenbach's decisions.
When Barr starts selling Plan B, probably by the end of the year, women will not be able to buy it as freely as most other over-the-counter medicines. Only licensed pharmacies can sell the pills, and only then from behind the counter to adults who present valid photo identification. The contraceptive will probably cost $25 to $40 a dose.
As a condition of approval, Barr agreed to use anonymous shoppers and other methods to check whether pharmacists are enforcing the age restriction.
Von Eschenbach said there is not enough evidence that girls 17 and younger safely can use Plan B on their own.
Bruce Downey, Barr's chairman, pledged to keep working with the FDA to try to eliminate the restriction.
Material from The Washington Post is included in this report.
Copyright © 2006 The Seattle Times Company