Federal Court Rules FDA Must Reconsider Plan ...( FDA Ordered to Make a Decision Based ...),Health

FDA Ordered to Make a Decision Based on Scientific Fact, Not Politics

NEW YORK, March 23 /PRNewswire-USNewswire/ -- Today, the U.S. District Court for the Eastern District of New York rejected the Food and Drug Administration (FDA) decision to limit over-the-counter access to the emergency contraceptive Plan B to women over 18, ruling that it was based on politics and ideology, rather than science. The court ordered the agency to reconsider its decision. It also ordered the FDA to act within 30 days to extend over-the-counter access, which is currently limited to 18 year olds and over, to 17 year olds.

"Today's ruling is a tremendous victory for all Americans who expect the government to safeguard public health," said Nancy Northup, president of the Center for Reproductive Rights, which brought the suit against the FDA.

"The message is clear -- the FDA should put medical science first and leave politics at the lab door. We are encouraged that the agency, now under new leadership, will take that message to heart."

The Center for Reproductive Rights sued the FDA in 2005 for failing to grant over-the-counter status to Plan B against the advice of scientific experts and in violation of its own procedures and regulations. In 2006, the FDA agreed to make Plan B available without a prescription, but only to women over 18 and only behind the pharmacy counter. The Center continued to pursue its lawsuit, Tummino v. von Eschenbach, to ensure that Plan B would be granted true over-the-counter status and made available to all women, including young women who might benefit most from this form of contraception.

"According to the FDA's own rules, the only legitimate criteria for making a drug available without a prescription are safety and efficacy," said Northup. "Emergency contraception is proven safe and effective and today, all women -- including young women f
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