Thursday, March 26, 2009

Court tells FDA to rethink Plan B contraceptive

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Pills line the shelves of a pharmacy in Los Angeles April 16, 2007. [Agencies]

NEW YORK - A U.S. court on Monday ordered the Food and Drug Administration to reconsider its decisions on the sale of the Plan B emergency contraceptive and ordered its producer to make the pills available to 17-year-olds without a prescription.

The U.S. District Court for the Eastern District of New York, in a 52-page ruling, said its order to make Plan B available to 17-year-olds under the same conditions it is currently available to older women must be complied with within 30 days.

The controversial Plan B, also known as the morning after pill, is now available without a prescription to women 18 and over to reduce the risk of unwanted pregnancy after sexual intercourse. Women 17 and under have been required to get a prescription for the drug.

The contraceptive, which works best when used within 24 hours of sexual intercourse, is sold by Barr Pharmaceuticals, which was recently acquired by Teva Pharmaceutical Industries Ltd.

The FDA was also ordered to reconsider its decisions for Plan B over-the-counter sale. It is currently available only behind the counter, so those who want to use the drug must ask a pharmacist for the pills.

Plan B's availability without a prescription in the United States was repeatedly delayed during the Bush Administration amid opposition from anti-abortion groups.

It was ultimately approved with the age and availability restrictions that will now be reconsidered by regulators.

"The court recognized that the FDA favored politics over science, ideology over women's health, and violated the law in the process," Nancy Northrup, president of Center for Reproductive Rights, said in a statement.

"Emergency contraception is proven safe and effective, and today we have succeeded in expanding access to 17-year-olds and are one step closer to making it fully available to all women," she said.

In making its ruling, the court said it would be premature to take up various constitutional challenges to the FDA's decisions regarding Plan B.

taken from : China Daily

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