| FDA clears wider access for "morning-after"
WASHINGTON (Reuters) - The "morning-after" contraceptive pill can be sold to those 18 and older in the United States without a prescription, the Food and Drug Administration ruled on Thursday, ending a three-year battle over the morality of wider access and use by teenagers.
The FDA ordered Barr Pharmaceuticals Inc.'s Plan B pills must stay behind pharmacy counters to prevent those under 18 from receiving the drug without a prescription.
Backers welcomed the decision but balked at the age limit, saying all women needed quick access to the pills in order for them work. Two Plan B pills - sold by prescription in the United States since 1999 - can prevent pregnancy if taken within 72 hours of intercourse.
Canada's Health Ministry approved the sale of Plan B from pharmacists without a prescription in 2005 and emergency contraception has been widely available in French schools from school nurses since 2000.
The FDA decision angered conservative supporters of George W. Bush, and one group said it was considering a legal fight.
FDA officials said the Plan B regimen was safe and effective for women when taken as directed, but should not be used for routine birth control.
"We think providing more options to women and patients is beneficial to public health," Dr. Steven Galson, head of the FDA's Center for Drug Evaluation and Research, told reporters.
Women's groups said wider access to Plan B could reduce unwanted pregnancies and abortions. "There's no scientific or medical reason" for the age limit, said Amy Allina, program director for the National Women's Health Network.
Conservative groups said age enforcement was impossible. Opponents of easy access say it could increase promiscuity and sexually transmitted diseases, particularly among teenagers.
The Family Research Council said the FDA overreached. The Christian lobbying group said it would pursue legal and legislative options.
"An agency charged with protecting the health interests of the country must be held to high standards," Tony Perkins, the council's president said.
The FDA said women and men must show proof they are at least 18 to buy the emergency contraceptive without a prescription, and younger girls still need a doctor's order.
Barr agreed to monitor age enforcement and to limit Plan B distribution to health clinics and stores with pharmacies. Nonprescription packaging should be available by the end of the year. Prescriptions are available now.
Barr Chief Executive Bruce Downey welcomed the decision but said "We still feel that Plan B should be available to a broader age group without a prescription." Barr initially wanted to sell Plan B over the counter without age limits.
Aimee Hess, a health-care analyst at Rochdale Research, said Plan B was a modest-sized product for Barr with estimated annual sales of about $30 million. "Sales could double within the next year or two, and a major emotional issue has been dealt with," Hess said.
Approval prompted Democratic Senators Patty Murray of Washington and Hillary Rodham Clinton of New York to end their objection to a Senate confirmation vote on Bush's pick to run the FDA, acting Commissioner Andrew von Eschenbach.
Murray, Clinton and other Plan B supporters argued that repeated delays since the initial bid in April 2003 were triggered by politics rather than scientific concerns.
FDA approval came three days after Bush publicly weighed in on the controversy, saying he supported the age limit on nonprescription sales.
"The FDA made clear that it will insist on stringent conditions and restrictions on access to reduce both health risks and opportunities for abuse, especially to protect minors," White House spokeswoman Dana Perino said.
Plan B pills contain higher doses of progestin, a hormone used in prescription birth-control pills. Women are supposed to take two tablets 12 hours apart.
The pills block the release or fertilization of an egg. Some research suggests Plan B also may keep a fertilized egg from attaching to the womb, and some opponents considered that mechanism tantamount to abortion.
Plan B is different from RU-486, a pill that causes an abortion early in pregnancy by blocking the hormone that keeps a fertilized egg implanted in the uterus.
Barr shares rose 11 cents to $58.08 in afternoon New York Stock Exchange trade.
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