- The Washington Times - Friday, August 26, 2005

The U.S. Food and Drug Administration delayed a vote yesterday on whether to approve a plan that would allow over-the-counter sales of a “morning-after” pill for girls 17 and older and prescription sales of the drug for girls 16 and younger, saying it wants public input on the issue.

The FDA yesterday told Barr Pharmaceuticals Inc., manufacturer of the pill known as Plan B, that scientific data support the safe over-the-counter use of the drug for females 17 and older. FDA officials said they think girls 16 and younger should not be given the drug without a doctor’s prescription. How such a split system would work needs more study and comment from the public, they said.

At a press briefing yesterday afternoon, FDA Commissioner Dr. Lester Crawford said, “I can’t say how long it will take … but we’re committed to doing this expeditiously.”

Dr. Crawford said there will be a 60-day comment period to gather public reaction to the proposal.

“Enforceability” is the major issue that must be addressed before this plan could be put into effect, he said.

“The FDA cannot have inspectors in every pharmacy, but we must make sure this approach is legally enforced, and that will be complicated …,” Dr. Crawford added.

Conservative pro-family organizations that had lobbied for the FDA to deny Barr’s application for over-the-counter use of Plan B say they will continue their campaign.

The lobbying became more intense in recent days, as the FDA indicated it would decide the issue yesterday. Those groups commended the FDA’s delay, while Planned Parenthood Federation of America and other pro-choice organizations denounced it.

“It’s naive to assume that any OTC scheme for the morning-after pill could be effective,” said Wendy Wright, senior policy director for Concerned Women for America (CWA).

She foresees the possibility of 17-year-old girls buying the pills for 13-year-olds. “Even worse, pedophiles could purchase them for their victims,” Miss Wright said.

Pia de Solenni, director of life and women’s issues for the Family Research Council (FRC), said the British press has reported that one 10-year-old girl in England obtained the morning-after pill on at least three different occasions.

Barr Pharmaceuticals said it is “disappointed” the FDA did not approve its application. It said the drug will remain on the market as a prescription medication in the United States pending FDA action.

Barr says that within 72 hours of unprotected sex, Plan B can reduce the risk of pregnancy by up to 89 percent. It is most effective when taken in the first 24 hours after intercourse.

CWA says studies indicate that easing access to the emergency contraceptive does not decrease abortion or pregnancy rates but does increase sexually transmitted disease rates.

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