By Lisa Richwine
REUTERS
August 26, 2005

WASHINGTON (Reuters) - U.S. officials deferred ruling on over-the-counter sales of Barr Pharmaceuticals Inc.'s "morning-after" contraceptive on Friday, sparking charges that repeated delays were motivated by politics rather than science.

U.S. Food and Drug Administration Commissioner Lester Crawford said Barr's bid posed "unique regulatory issues" -- chiefly how to keep a prescription requirement for girls younger than 17 while easing access for older women.

The FDA will take public comments for 60 days. Crawford said he could not predict when a decision would be made.

Barr has asked to sell the product, Plan B, to females 16 and older without a prescription. The FDA said its scientists supported safe, over-the-counter use by women 17 and older.

How to enforce an age limit is the "key unresolved question," Crawford said. "FDA cannot have an inspector in every pharmacy."

Barr shares fell $1.09, or 2.35 percent, to close at $45.22 on the New York Stock Exchange.

Plan B pills contain higher doses of progestin, one of the hormones used in birth-control pills. Women are supposed to take two tablets 12 hours apart.

Reproductive rights groups and other supporters say easier access would help women get the pills in time following a rape or broken condom, leading to fewer abortions. Conservative opponents charge that wide availability would lead to more promiscuity and sexually transmitted diseases.

"It's jaw-dropping the extent to which the (FDA) keeps moving the goal post" for over-the-counter sales, said Kirsten Moore, president of the Reproductive Health Technologies Project.

Moore said there was no way to ensure underage girls would not get the pills. "I think this is the end of it," she said.

Concerned Women for America (CWA), a conservative group that opposes over-the-counter sales, welcomed the FDA action.

"It is naive to assume any over-the-counter scheme for the morning-after pill would be effective," said Wendy Wright, CWA's senior policy director. "A 17-year-old could buy it for a 13-year-old girl. Or worse yet, a pedophile could purchase this drug for his victims."

Sens. Patty Murray of Washington and Hillary Clinton of New York, both Democrats, charged Bush administration officials with breaking a promise to rule on Plan B by September 1. Murray and Clinton agreed to drop objections to a vote on Crawford's nomination as FDA commissioner in light of that pledge.

"It is a breach of faith to have this administration give us their word that a decision would be made, and have that promise violated. FDA's only criteria for approval should be safety and efficacy, not politics and ideology," the senators said in a joint statement.

Barr's bid to sell Plan B without a prescription has stalled several times.

An FDA panel of outside advisers voted 23-4 in December 2003 to recommend reclassifying Plan B from a prescription to over-the-counter drug, but the FDA rejected that advice in May 2004.

Barr later reapplied for approval of an over-the-counter version for females 16 and older. The FDA missed a January deadline to rule on the application.

Barr said in a statement it was "disappointed" by the latest FDA ruling and thought the delay was unjustified. The company said it would continue to press for over-the-counter approval for Plan B, which will remain available by prescription.

Plan B is different from the "abortion pill" RU-486, which can terminate an early pregnancy by blocking the hormone that keeps a fertilized egg implanted in the uterus. RU-486 also is known as Mifeprex or mifepristone.

Plan B works by blocking the release or fertilization of an egg. Some research suggests Plan B also may keep a fertilized egg from attaching to the womb.