FDA to consider morning-after pill

2 panels plan hearing on over-the-counter sale of the prescription drug

December 12, 2003|By NEW YORK TIMES NEWS SERVICE

Two panels for the Food and Drug Administration will consider early next week whether to allow the so-called morning-after pill, now a prescription drug taken after intercourse to prevent pregnancy, to be sold over the counter.

But unlike other more ordinary hearings for drugs such as allergy medications to be shifted from prescriptions to widespread availability, this hearing has become entangled in the thorny politics of abortion, raising questions of when a pregnancy begins and who decides.

If approved, the drug will be the first emergency contraceptive sold over the counter. Known as "Plan B" - when "Plan A," meaning contraception, doesn't work or is skipped - the drug would not only be sold in drugstores, but could be as readily available as aspirin, on the shelves of supermarkets, convenience stores or gas stations.

The drug, essentially two high-dose birth control pills, can prevent up to 89 percent of unwanted pregnancies if taken within 72 hours of unprotected intercourse; but the sooner it is taken, the more effective it is.

It remains uncertain how the two committees will vote at the end of their joint hearing on Tuesday, or whether the FDA will take their advice. The Bush administration opposes abortion and is far more conservative on birth control issues than the Clinton administration, which in 2001 approved mifepristone, or RU-486, a pill that induces abortion in the first few weeks of a pregnancy.

And while the agency's panels include abortion opponents, such as Dr. Joseph B. Stanford of the University of Utah, who opposes hormonal contraception, they also include one of the staunchest advocates for emergency contraception, Dr. James Trussell of Princeton.

On each side of the issue, letter-writing campaigns to the agency as well as e-mail campaigns to rally support have intensified leading up to the hearing. The agency is allotting individuals and groups just a few minutes each to speak.

Proponents say over-the-counter approval would make the pills easy to obtain. Many women still do not know about them, and those who do usually do not have a prescription available if they need the drug.

Opponents say that making the pills available over the counter would be an invitation to medical nightmares, with some people, particularly teen-agers, using them repeatedly, though the safety of repeated use has not been well studied.

Also, they say, women opposed to abortion who believe that pregnancy begins at fertilization might not realize they may be preventing a fertilized egg from implanting.

Among the groups in favor of selling the pills without prescriptions are the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.

Opponents include the U.S. Conference of Catholic Bishops and 44 members of Congress, including the House majority leader, Tom DeLay of Texas, who asked the FDA's advisory committee members to vote no on the over-the-counter application.

One of the largest groups opposing abortion, the National Right to Life Committee, has not taken a position.

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