US urged to allow wider emergency contraception

A leading international medical journal has called on the U.S. Food and Drug Administration to dismiss political pressure and allow emergency contraception to be sold without a prescription.

The Lancet, in its upcoming May 20 edition, said acting FDA Commissioner Andrew von Eschenbach must make an independent decision on Barr Pharmaceuticals Inc's bid to sell its Plan B drug - also known as a "morning-after pill" - over-the-counter, especially if he is to lead the agency on a permanent basis.

President Bush tapped von Eschenbach to run the agency full-time earlier this year, but his nomination has stalled in the U.S. Senate, where two Democrats have blocked any vote pending a decision on the drug.

Editors at the Lancet, published in London, said von Eschenbach's failure to act indicates he may not be independent enough to run the FDA.

"His failure to issue a decision undermines both his credibility and that of the agency. Von Eschenbach should move quickly to approve Plan B to show he has the independence needed to be an effective leader of the FDA," the editorial said.

"The agency is stalling, apparently to avoid offending antiabortion supporters of President Bush, who claim that the contraceptive is an abortifacient," it added.

The FDA has described Plan B, a set of two pills containing higher levels of a hormone used in regular birth control pills, as contraception. If taken within 72 hours, it can prevent pregnancy, unlike the abortion pill RU-486 regimen which ends an established pregnancy.

It has been available with a doctor's prescription since 1999, but a growing number of pharmacists in some states have refused to fill the orders.

The Lancet's comments are the latest in a string of media editorials calling for the FDA to make a decision.

Last August, former FDA Commissioner Lester Crawford ruled the drug was safe and effective over-the-counter but said other regulatory issues remained. He resigned abruptly a month later.

Women's groups and other supporters have said easier access is key for women to get the pills in time and would help reduce the number of abortions. A bipartisan group of 62 members of Congress has also called for wider availability.

Opponents have said making the drug easier to get could trigger promiscuity and encourage the spread of sexually transmitted diseases.

"The FDA must be led by a commissioner willing to take independent stands, following the best judgment of his expert staff and scientific advisers, even when that means incurring the wrath of patients' groups, industry, Congress and the White House," the Lancet said.

Representatives for the FDA could not be immediately reached for comment.

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SOURCE: American Journal of Obstetrics & Gynecology