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FDA Approves Over-the-Counter Sales of Plan B

August 24, 2006

Birth Control • FDA Approves Generic 'Plan B' Pill • Over-the-Counter Contraceptive Pill May Not Work • Ortho-Evra Patch Should Be Withdrawn: Public Citizen • Contraceptive Pill May Help Conception • Birth Control Pill Linked to Heart Disease • New Contraceptive Eliminates Women’s Periods • FDA Approves OTC Sales of Plan B • Wal-Mart Agrees to Stock Plan B in Connecticut Stores • Wal-Mart to Begin Dispensing "Morning After" Pill This Week • FDA: Birth Control Patch Needs More Study • Little Risk with Today's IUDs • Wal-Mart May Stock "Emergency" Contraceptives • New Warning Labels for Ortho Evra Contraceptive Patch • Feds Toughen Warning for Depo-Provera

The FDA has approved sales of the so-called "morning after" pill Plan B to women 18 and over without a prescription.

The birth control pill will remain prescription-only for women younger than 18. It will be sold only at licensed pharmacies, not convenience stores or service stations.

The pill's manufacturer, Barr Pharmaceuticals Inc., said it will use "anonymous shoppers" to ensure that pharmacies adhere to the prescription-only rule for younger women.

The manufacturer says that when it is taken within 72 hours following unprotected sex, the product reduces the risk of pregnancy by as much as 89%.

The drug delivers a surge of hormones, similar to a high dose of birth-control pills, interfering with fertilization and preventing implanation of a new embryo in the uterus. Most medical authorities do not consider this to be an abortion but so anti-abortion groups disagree.

Plan B is not the same as mifepristone, sometimes called RU-486, a pill that chemically induces an abortion.

Even when it was available only with a prescription, Plan B was not widely available in some areas. Wal-Mart did not stock it in its pharmacies until March, when it succumbed to pressure from Illinois, Massachusetts, Connecticut and other states.

Three Massachusetts women had sued Wal-Mart for not carrying the pill, leading to the state Board of Pharmacy's decision to require the chain to stock the drug.

The FDA's approval of Plan B removes an obstacle to the confirmation of President George W. Bush's nominee to head the FDA, Andrew von Eschenbach. Some Democratic senators, including Hillary Rodham Clinton of New York, had been threatening to block a confirmation vote until the FDA made a decision.

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