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FDA delays decision on ‘morning-after’ pill

WASHINGTON (BP)–A federal government agency has delayed a decision on whether to approve over-the-counter sales of a “morning-after” pill that pro-family advocates contend could cause abortion and increase sexually transmitted diseases among young people.

The U.S. Food and Drug Administration has extended its review of a request for non-prescription sale of the Plan B “emergency contraceptive” beyond the original deadline of Feb. 20, according to the pharmaceutical company seeking approval. Barr Pharmaceuticals Inc. expects a decision from the FDA by May 20, it said in a Feb. 13 news release.

The postponement of a decision offered some hope to pro-life and pro-family supporters inside and outside Congress that the FDA might reject a December recommendation from two of its advisory committees to approve over-the-counter sales of the controversial drug.

Plan B now can be purchased with a prescription, but supporters of over-the-counter sales argue the method’s value is limited by the need to obtain it quickly when sexual intercourse has occurred without the use of another form of contraception. Plan B is recommended for use in the first 72 hours after sex, but it is even more effective in the first 24 hours.

Plan B works by restricting ovulation in a woman, and supporters argue it will prevent unplanned pregnancies and abortions. Opponents, however, say the method also can work after conception, blocking implantation of a tiny embryo in the uterine wall. In such a case, an abortion occurs, pro-lifers point out. The medical establishment largely disagrees that blocking implantation constitutes an abortion.

In January, 49 members of Congress called on President Bush and FDA Commissioner Mark McClellan to deny the committees’ recommendation. They expressed concern that “adolescent exposure to sexually transmitted infection will increase because of the availability of [Plan B] over the counter. This availability may ultimately result in significant increases in cancer, infertility and HIV/AIDS.”

The Southern Baptist Ethics & Religious Liberty Commission endorsed the congressional effort on the basis of its impact on young people and newly conceived children.

“Emergency contraception” is basically a heavier dose of birth control pills. In the “morning-after” regimen, a woman takes two pills within 72 hours and another dose 12 hours later. In addition to Plan B, the FDA also has approved prescription use of another “emergency contraceptive,” Preven. The FDA approved Preven before Plan B in 1998.

The FDA’s Nonprescription Drugs and Reproductive Health Drugs advisory committees made their joint recommendation Dec. 16 after a day of hearings on the proposal.

The argument over whether “emergency contraceptives” cause abortions is partly a disagreement over the definition of pregnancy.

The American College of Obstetricians and Gynecologists, which supports over-the-counter sale of Plan B, says pregnancy does not begin until the fertilized ovum is implanted in the uterine wall. To pro-lifers, and those who abide by the traditional understanding, pregnancy begins with the union of a sperm and an egg — known as fertilization or conception.

ACOG’s redefinition of pregnancy took place in the mid-1970s. Its equating of implantation, which occurs about six days after fertilization, with the beginning of pregnancy explains why ACOG and others describe methods that prevent implantation as contraception rather than abortion.

Barr Pharmaceuticals, which is based in New Jersey, is expected to complete purchase of Plan B from the Women’s Capital Corp. of Washington, D.C., by Feb. 20.

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