- The Washington Times - Monday, July 31, 2006

1:38 p.m.

WASHINGTON (AP) — The government is considering allowing over-the-counter sales of the morning-after pill to women 18 and older. The surprise move today revives efforts to widen access to the emergency contraceptive almost a year after it was thought doomed.

The Food and Drug Administration notified manufacturer Barr Pharmaceuticals Inc. early today that it wanted to meet within seven days to iron out new steps the company must take in its three-year battle to sell the pill, called Plan B, without a prescription to at least some women.

“We think this is a positive development. We will see how the meeting goes and move forward from there,” company spokeswoman Carol Cox said.

Miss Cox could not predict how quickly the company could amend its FDA application, which already includes a plan to restrict distribution of the pills. The FDA said a final decision could be reached within weeks if talks with Barr go well.

The announcement came just 24 hours before President Bush’s nominee to lead the regulatory agency, Dr. Andrew von Eschenbach, was scheduled to appear before a Senate committee, where he was expected to face grilling on why the morning-after pill apparently had gone into bureaucratic limbo.

Meanwhile, two senators who have held up the nomination said today they would continue to do so until the agency makes a decision on the morning-after pill.

Democrat Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York vowed to continue holding up Dr. von Eschenbach’s confirmation as commissioner until the agency makes a final decision, Murray spokeswoman Alex Glass said. The two previously had allowed Dr. von Eschenbach’s predecessor, Lester Crawford, to be confirmed after receiving a pledge the FDA would act on the issue. Mr. Crawford resigned shortly after delaying a decision.

The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.

Contraceptive advocates and doctors groups say easier access to a pill now available by prescription only could halve the nation’s 3 million annual unintended pregnancies, and FDA’s own scientists say the pills are safe. In December 2003, the agency’s independent scientific advisers overwhelmingly backed nonprescription sales for all ages.

However, FDA rejected that recommendation, citing concern about young teens’ use of the pills without a doctor’s guidance. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription and setting up a program for pharmacists to enforce the age rule — just as age restrictions on cigarette sales are enforced.

Last August, FDA’s then-chief indefinitely postponed a decision, saying the agency needed to determine how to enforce those age restrictions — something it said would require the formality of writing new regulations.

The FDA reversed itself today, saying it had reviewed about 47,000 comments from the public, with an overwhelming majority supporting the view that the drug could be sold both as a prescription and nonprescription product.

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