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FDA panels urge non-prescription sale of ‘morning-after’ pill

WASHINGTON (BP)–Federal government advisers have recommended approval for over-the-counter sales of a “morning-after” pill that pro-life advocates contend can cause abortion.

Two advisory committees, meeting jointly, urged the Food and Drug Administration in a 23-4 vote Dec. 16 to endorse sale of the Plan B emergency contraceptive without a prescription. The FDA has targeted February for a decision on the panels’ recommendation, The Washington Times reported. While the FDA is not required to endorse its panels’ recommendations, it normally does.

Plan B now is approved for purchase 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 intercourse, 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 abortion. 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.

“Many women will buy the lie that they are actually preventing pregnancy, when in reality, in many cases, all they will have done is terminate a very early pregnancy, an abortion in other words,” said Barrett Duke, vice president of public policy for the Southern Baptist Ethics & Religious Liberty Commission. “In the name of compassion, these panels propose to reduce unwanted pregnancies and abortions by making it as easy to terminate a possible pregnancy as it is to buy a bottle of vitamins.”

Opponents of the method also contend it can be dangerous for women.

Wendy Wright, senior policy director of Concerned Women for America, called the FDA’s consideration of non-prescription sale of Plan B “quite astonishing.”

“Approving over-the-counter access to a high dose of this drug, when a lower-dose cannot be obtained without a medical exam, physician oversight and prescription, exposes women, teenagers and girls to complications such as blood clots and heart attacks,” Wright said in a written release.

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.

Barr Laboratories, a New Jersey firm that is acquiring Plan B from the Women’s Capitol Corp., said its method reduces the risk of pregnancy by 89 percent when taken in the first 72 hours and 95 percent when taken in the first 24 hours. In the past, the FDA has said emergency contraception is about 75 percent effective.

The country’s leading abortion-rights organizations supported the panels’ recommendation. Gloria Feldt, Planned Parenthood for America’s president, called the vote a “victory for all women and for sound public health policy. Wider access to emergency contraception will prevent hundreds of thousands of unintended pregnancies and abortions every year.”

The ERLC’s Duke, however, said there are multiple dangers with over-the-counter availability of emergency contraception.

“Women will respond to the fear factor and take this drug without knowing whether or not they are pregnant,” he said. “It is easy to imagine women and girls carrying a supply of these pills and taking them after sex every time they suspect that perhaps they might become pregnant.

“Women and, especially, girls will be encouraged to engage in sexual behavior because they will have a drug available to them that will protect them from having a baby,” Duke said. “As more people have sex, we will certainly see a meteoric rise in sexually transmitted diseases, and the magic pill won’t protect them from that.

“The magic pill is not perfect. Some of these girls and women will still end up pregnant.

“Greater convenience is not the answer to abortion or unwanted children,” Duke said. “The only way to prevent pregnancy is to abstain from sex. It is disappointing to think that the institution we trust to protect our health will violate that trust by approving over-the-counter sales of a drug that will result in so much damage to so many women and girls. If we want healthier, happier women, we need to promote healthy behavior and responsibility by women and men, not reckless abandon.”

The FDA’s Nonprescription Drugs and Reproductive Health Drugs advisory committees made their joint recommendation 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.