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    Maker of Morning-After Pill Ready for Over-the-Counter Studies


    As the drug manufacturer met with the FDA, some experts said they were pleased the drug could become available without a prescription. But some questioned the need for more research before the change of status is authorized.

    "The FDA has enough information right now, and they have the legal authority to make the switch to OTC without requesting any further information," said David Grimes, MD, vice president of biomedical affairs for Family Health International in Research Triangle Park, N.C.

    Plan B, Grimes said, as well as the combination progestin and estradiol drug Preven, are both safe enough for women to get over-the-counter if they need emergency contraception.

    Women who are raped, whose regular birth control fails, or who simply forget to use contraception in the heat of the moment can take the so-called morning-after pill up to 72 hours after sexual intercourse.

    Opponents, including the Vatican, contend emergency contraception is early abortion and oppose teenage access to the pills.

    In a prepared statement Wednesday, The American Life League spoke out against products like Plan B and said supporters who claim the drugs are as safe as aspirin and do not cause abortion are "deliberately misleading the media and the American people."

    Proponents assert that emergency contraception doesn't cause abortion -- if a woman already is pregnant, it won't work.

    Taken quickly enough, the pills may prevent fertilization of an egg, says Paul Blumenthal, MD, MPH, a Johns Hopkins University gynecologist and Planned Parenthood adviser. If fertilization already has occurred, the pills prevent an egg from implanting into the uterus, preventing the pregnancy from progressing.

    Two brands of morning-after pills, Preven and Plan B, have sold in the U.S. by prescription since 1998; special high doses of regular birth control pills work, too.

    "It's as safe as any other over-the-counter drug available in the U.S.," Blumenthal said. He cites thousands of women who have used emergency contraception without serious side effects; temporary nausea and breast tenderness are typical.

    At a news conference held Wednesday in Washington, D.C., public health experts had more to say about the burdens of unwanted pregnancy.

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