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FDA delays action on sale of nonprescription morning-after pill

WASHINGTON—The Food and Drug Administration once again deferred action on making the so-called morning-after pill available without a prescription, saying the drug was safe for women 17 and older, but that issues surrounding its potential sale to younger teens remain unresolved.

Friday's action prompted outrage from women's rights supporters, who accused the agency of playing politics and dragging its feet after nearly two years of political squabbling on the merits and morality of the medication known as "Plan B."

FDA Commissioner Lester M. Crawford said the drug wouldn't be available for sale until the agency sorts out whether age alone should determine its availability without prescription, whether the prescription and nonprescription versions can be marketed in the same package and whether the age-limit regulation can be effectively enforced.

"What we are saying today is that the agency is unable at this time to reach a decision," Crawford added. "We need to resolve these policy and regulatory questions before we can reach a final decision on the underlying science that was presented to us."

The agency has set a 60-day comment period for public input on how to address its concerns. Crawford decided against the usual 90- to 120-day comment period, saying he didn't want to delay the decision further.

The maker of Plan B, Barr Laboratories of Woodcliff Lake, N.J., was disappointed with the delay.

"We are disappointed that the FDA did not approve our application," said Bruce L. Downey, the drug maker's chairman and CEO in a prepared statement. "While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B" as an over-the-counter drug.

Those who supported making the drug available without a prescription were far less diplomatic and even less hopeful about its prospects.

"I am deeply skeptical that it will ever happen. It's extraordinary to me the degree to which the agency has acted in bad faith. They're turning their back on their own mission and mandate to promote public health," said Kirsten Moore, president of the Reproductive Health Technologies Project.

Emergency contraceptives have been sold by prescription in the United States since 1998. They're essentially higher doses of the hormones that conventional birth control pills contain. They work by either blocking the release of an egg from the ovaries or by preventing a fertilized egg from being implanted in the walls of the uterus.

When taken within 72 hours of intercourse, they can prevent pregnancies with about 89 percent reliability, according to the FDA. But women have complained that it's often difficult to reach a physician and obtain a prescription during the 72-hour period when the drug is most effective.

The country's largest gynecologists' group, the American College of Obstetricians and Gynecologists, estimates that over-the-counter Plan B sales could cut in half the 3 million unwanted pregnancies in the United States each year.

Two FDA advisory panels voted overwhelmingly to approve the sale of Plan B without a prescription in December 2003, finding that the drug was safe and effective. But strong opposition by religious and conservative groups and the Bush administration has delayed final agency action on the measure for nearly two years.

The FDA was first expected to decide the matter in February 2004, but requested more time to study adolescent use of the drug.

When the FDA missed another deadline to decide in January 2005, Sens. Hillary Clinton, D-NY, and Patty Murray, D-Wash., blocked a vote on then-acting FDA Commissioner Lester Crawford's bid to become the agency's permanent chief.

The senators dropped their opposition only after the Bush administration promised action on the measure by Sept. 1. Crawford was subsequently confirmed as FDA commissioner in July.

In a joint statement, Murray and Clinton expressed outrage, saying the Bush administration broke its promise to decide the issue by Sept. 1.

"Today's move serves only to increase questions about FDA's status as an independent agency. ... We can only infer that FDA—and its newly confirmed administrator, Lester Crawford—are working to put ideological beliefs ahead of women's health."

Eleanor Smeal, president of the Feminist Majority Foundation, said, "These stall tactics are only harming women and increasing the need for abortions."

But abortion opponents such as Pia deSolenni, director of life and women's issues at the Family Research Council, applauded the FDA's decision, saying that it would be difficult, if not impossible, to keep the drug out of the hands of young girls.

"We're glad that there's been a hiccup," in the effort to sell the drug without a prescription, deSolenni said.

Seven states have already allowed Plan B to be sold without a prescription—Washington, California, Alaska, Hawaii, New Mexico, Maine and New Hampshire. In addition, morning-after pills are available in 102 countries, 34 of which require no prescription.

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(c) 2005, Knight Ridder/Tribune Information Services.

GRAPHIC (from KRT Graphics, 202-383-6064): 20050826 MORNINGAFTERPILL

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