From: Reuters
Published March 4, 2008 04:48 PM

Court dismisses suit on Barr's Plan B pill

By Kim Dixon

WASHINGTON (Reuters) - A federal judge on Tuesday dismissed a lawsuit seeking to halt sales of the only "morning-after" contraceptive pill available in the United States without a prescription.

The suit was filed against U.S. health regulators over their decision to allow non-prescription sales of Barr Pharmaceuticals Inc's Plan B pill.

The U.S. Food and Drug Administration and Barr were sued by the Association of American Physicians and Surgeons and other groups seeking to overturn the FDA decision.

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The pill can reduce the risk of pregnancy when taken within three days of intercourse.

The U.S. District Court for the District of Columbia granted the FDA's and Barr's motion to dismiss the suit, saying the plaintiffs had failed "to identify a single individual who has been harmed by Plan B's OTC (over-the-counter) availability," according to the ruling.

Backers of reproductive rights applauded the decision.

"They still don't have any evidence in terms of why they think it is harmful," said Janet Crepps, deputy director for domestic programs at the Center for Reproductive Rights. "This is the right decision for women."

Plan B was approved in 1999. The FDA broadened the approval in 2006 to allow sale to adults without a prescription. The pills must be kept behind pharmacy counters and can be sold to girls under the age of 18 years only with a doctor's order.

The Association of American Physicians and Surgeons said it was reviewing the ruling and had not made a decision yet about appealing.

The company said Plan B sales contributed to its 12 percent increase in overall drug sales last year, but it would not provide exact sales figures.

Separately, on Monday, another U.S. court found the patent for Bayer AG's Yasmin contraceptive drug to be invalid, paving the way for Barr to sell a generic version.

"It's a big win for Barr," Natixis Bleichroeder analyst Corey Davis said of the Bayer ruling. "There's nobody I'm aware of that is waiting in the wings to launch after Barr's six months of exclusivity, so this could be one of those nice generic products with long tail on it."

Barr shares were up $3.66, or 8 percent, to $49.90 in afternoon trade on the New York Stock Exchange.

NO STANDING

Plan B pills contain higher doses of progestin, a hormone used in prescription birth control pills for 35 years. Two pills cut the odds of pregnancy by nearly 90 percent when taken within three days of sexual intercourse.

The Plan B lawsuit claimed the drug was not proven safe without a prescription and sought to reverse the FDA decision and require a prescription for all Plan B sales.

FDA spokeswoman Rita Chapelle said the agency was pleased with the dismissal of the suit. Barr spokeswoman Carol Cox, who called the lawsuit "meritless," said her company was also pleased.

Anti-abortion groups, including the Family Research Council and Concerned Women for America, had joined the doctors' group in trying to reverse the FDA decision.

The groups failed to prove their standing to sue, the court said. In its conclusion, it said that "plaintiffs have failed to exhaust their administrative remedies and have therefore failed to state a claim upon which relief can be granted."

The Center for Reproductive Rights is also suing the FDA, but it is seeking the opposite course of action. In its lawsuit against the agency, it argues that restricting the drug for girls under 18 was based on politics and not science.

The group is waiting for a judge in New York to rule on its summary judgment motion.

(Reporting by Kim Dixon; additional reporting by Bill Berkrot in New York; editing by Tim Dobbyn and John Wallace)

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