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April 08, 2004

Right wingers trying for Plan B restrictions

Safe emergency contraception. Something to fall back on if a condom breaks. What's not to like?

The distributor of the emergency contraceptive "Plan B" and the government are discussing a compromise that would place some restrictions on proposed over-the-counter sales of the "morning-after" pill -- an outcome that critics say would be based more on election-year politics than on science.

Although a Food and Drug Administration advisory panel voted 23 to 4 in December in favor of making the drug available on drugstore shelves, the proposed compromise would ignore important elements of that recommendation, said several people familiar with the negotiations but not allowed to speak on the record.

The application to give Plan B full over-the-counter status has been sharply criticized by social conservatives who say it would lead to increased teenage promiscuity.

The ongoing talks have focused on possibly setting a minimum age for purchasers and keeping the drug behind drugstore counters so pharmacists would control sales. As word of the possible restrictions has spread, critics have stepped up a campaign to try to persuade the FDA to approve the application without restrictions.

In a pointed editorial published today in the New England Journal of Medicine, the editor and two members of the FDA advisory panel wrote that the agency's actions suggest that its "decision-making process is being influenced by political considerations."

"Although the FDA is frequently criticized by politicians and others for being either too lenient or too tough . . . the integrity of the process has seldom been questioned," the editorial said. "To squander that trust by allowing political pressure to delay a decision to make safe and effective emergency contraception available over the counter seems to us a serious error."

The FDA said it could not respond to the criticism because it is still reviewing the application.

Plan B consists of two high doses of a hormone used for birth control called levonorgestrel, which has been shown to prevent pregnancy if taken within 72 hours after having sex. Unlike Mifeprex, or RU-486, it is not considered an abortion pill, since it prevents a pregnancy from starting. Advocates of wider use say it would result in a decline in unwanted pregnancies and abortions.

Posted by Norwood at April 8, 2004 04:32 PM
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