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FDA expected to back expanded use of Plan B contraceptive

WASHINGTON -- The Food and Drug Administration will approve an application, possibly today, that would make the emergency contraceptive Plan B available without a prescription to women 18 and older, say sources long involved with the issue.

Although Barr Laboratories, the maker of Plan B, reported that it had not received any formal notification about its application, the sources said they had been told a decision to expand usage of the long-debated contraceptive, commonly known as the ``morning-after pill," is imminent. The sources spoke on the condition of anonymity because of the strict FDA rules on releasing information regarding drug approvals or rejections. No one at the FDA provided information for this article, nor would officials there comment on whether the drug would be approved.

Many social conservatives have battled to keep the drug from becoming available without a prescription. Some say that it could encourage promiscuity, and others say use of the pill causes a very early abortion. Their position had for almost three years trumped an overwhelming scientific consensus that the drug could be safely dispensed without a prescription.

The expected approval would occur a year after former FDA commissioner Lester Crawford created a firestorm by ruling that the agency did not have the authority to approve a drug for over-the-counter use for women while requiring prescriptions for girls. But in recent weeks, President Bush and acting FDA Commissioner Andrew von Eschenbach signaled that they are willing to back off from that position and allow the drug to be available as Barr -- and many women's health advocates -- have long advocated.

An approval would also open the way for von Eschenbach to be confirmed as FDA commissioner. Democratic Senators Hillary Rodham Clinton of New York and Patty Murray of Washington have held up the nomination because of what they said was the agency's refusal to make a decision about the drug. They accused the administration of politicizing science by not accepting the recommendations of an advisory panel and the FDA's scientific staff.

The morning-after pill is a high dose of the most common ingredients in regular birth control pills. Taken within 72 hours of unprotected sex, the two-pill series can significantly lower the risk of pregnancy.

Although the FDA concluded that the pill works like a traditional contraceptive -- preventing an egg from becoming fertilized -- it has not ruled out the possibility that it can also prevent a pregnancy by keeping a fertilized egg from implanting in a woman's uterus. That possibility has led some social conservatives to liken the contraception to abortion.

Plan B was approved for prescription use in 1999.

Word that approval might be imminent set off a flurry last night on Capitol Hill and among family-planning advocates.

``This is something that women's health groups have been working on for more than a decade," said Amy Allina of the National Women's Health Network.

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