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FDA weighs easier access to next-day birth control

Emergency contraceptive pills, now sold only with a doctor's prescription, could soon be available on supermarket and drug store shelves along with aspirin and cough syrup.

Advisers to the Food and Drug Administration will meet today to consider an application from the major US maker of the "morning-after pill" to sell the drug, called Plan B, without a doctor's oversight. FDA staff, in a report released yesterday, supported the move to over-the-counter sales, suggesting that there is little potential for misuse and that women would benefit from earlier access to the drug. Women must take the pill within 72 hours of unprotected intercourse to have a high likelihood of preventing pregnancy.

The petition from Barr Laboratories, which contends the drug is safe and simple to use, is drawing support from dozens of medical and women's organizations. They say it could prevent as many as 1.5 million unintended pregnancies a year and as many as 700,000 abortions.

But the move to sell the drug off the shelf is adamantly opposed by others, including the US Conference of Catholic Bishops, which says the pills cause abortion and should not be available without prescription, particularly to teenagers.

Two FDA advisory committees, meeting jointly today, will sort through the arguments and make a recommendation to the FDA commissioner. The FDA typically follows its panels' guidance, but is not bound by it, and may take months to make a final decision.

In Massachusetts, where there are an estimated 70,000 unintended pregnancies every year, advocates say women face significant barriers to obtaining the drug that would be eased if it were available over the counter. Half of all hospital emergency rooms refused to provide the morning-after pill to women who asked for it, according to a survey conducted last year by National Abortion and Reproductive Rights Action League Pro-Choice Massachusetts. A quarter of all emergency rooms did not provide the drug to rape victims, the survey found.

Women able to obtain valid prescriptions have gotten moral lectures from pharmacists when they tried to purchase the drug, added officials at the Planned Parenthood League of Massachusetts. Others were turned away because pharmacies did not keep it in stock. As many as 42 percent of women in Massachusetts may live in areas where it is difficult to get the prescription filled, they said.

"Emergency contraception has tremendous potential to reduce unintended pregnancy," said Melissa Kogut, executive director of NARAL Massachusetts. "But time is of the essence. Women are more likely to use it if they can get it -- without a doctor's visit -- at their local drug store."

But Wendy Wright, senior policy director for Concerned Women for America, a group that also opposes abortion, says "having this available through pharmacists is bad enough. If it's available on the shelf, it's going to be used repeatedly and not only in emergency situations. Women will suffer very serious complications from taking this."

The drug is already sold without a prescription in 33 countries, according to Barr Laboratories, although in many it must still be obtained from a pharmacist. It is available over the counter in Israel, Norway, and Sweden. In the United States, five states have changed their laws to allow pharmacists to dispense Plan B without a prescription: Washington, California, Alaska, New Mexico, and Hawaii. Last year, Planned Parenthood proposed legislation in Massachusetts to allow pharmacists to dispense it without a doctor's order and to require hospital emergency rooms to provide it to rape victims, but the bill is stalled in the Legislature.

Prescriptions can be written for a single round of two pills, or for multiple doses. Plan B has been marketed in the United States since 1999 by Women's Capital Corp., which is in the process of selling it to Barr. The pill, which the FDA estimates was used by 1.2 million American women between July 2002 and July 2003, contains progestin and works by preventing ovulation, preventing fertilization, and preventing implantation of a fertilized egg. It has no effect after an egg is firmly implanted in the uterine wall.

But the ability of the drug to hamper implantation is at the heart of the Catholic bishops' opposition. They believe life begins when an egg is fertilized, and oppose use of the drug as part of their overall opposition to abortion. "Many women don't realize this could end the life of a new embryo," said Cathy Cleaver Ruse, a spokeswoman for the bishops. "In addition, we don't believe that minor girls should have over-the-counter access to drugs that will cause abortion."

In addition, the bishops say that the United Kingdom and New Zealand have issued warnings that the drug presents a risk of ectopic pregnancy, a potentially fatal condition in which the fertilized egg becomes lodged in the fallopian tube instead of the uterus.

But after reviewing side effects reported directly to the FDA, as well as studies, submitted by Barr, from the United States and other countries, the FDA staff found no increased risk of ectopic pregnancy. That problem occurs in about 2 percent of pregnancies in the United States and in about 1.5 percent of cases in which women used Plan B. The FDA medical officer who reviewed safety data on Plan B wrote that it has "an acceptable margin of safety with a low misuse and abuse potential." The drug's main side effect is nausea, which affects about 23 percent of those who take it.

Barr's head of research, Carole Ben-Maimon, said company studies modeling over-the-counter use and reports from abroad showed, in addition, "there's no evidence of an increase in promiscuity or sexually transmitted diseases."

Making the drug available over the counter has been endorsed by the American College of Obstetricians and Gynecologists, which for now has urged its members to provide sexually active women with prescriptions they can keep at home in case they need them.

Women seeking to avoid a pregnancy must take the first of two Plan B pills as soon as possible after unprotected sex, and the second 12 hours later. Plan B cuts the risk of pregnancy by 95 percent if taken within 24 hours, but that drops to 89 percent at 72 hours, according to the company's research.

Alice Dembner can be reached at Dembner@globe.com.

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