Plan B to be sold on demand

FDA approves sales of morning-after pill without prescription

August 25, 2006|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON -- The Food and Drug Administration announced yesterday that the Plan B morning-after pill can now be purchased without a prescription by women 18 and older. The decision ends a bitter three-year political fight, but doctors say it is not likely to change the behavior of women in the ways that conservatives and liberals had argued.

Women will have to show proof of age in order to buy the emergency contraception, which will be kept behind counters in pharmacies and health clinics, but they won't need a prescription any longer. Over-the-counter sales should begin by the end of the year, the drug's maker said.

By limiting the sales to adults, the acting FDA commissioner, Dr. Andrew C. von Eschenbach, said in a memorandum that the agency had found a way to ease access to the morning-after pill while protecting the health of teenage girls.

The resolution clears the way for von Eschenbach's confirmation as permanent FDA commissioner. Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington called the approval a long overdue but positive step and said they were lifting the hold they had placed on the nomination because the agency had repeatedly delayed making a decision.

Conservative opponents complained that the FDA had buckled to political pressure. They have argued that easier access to the pill would increase promiscuity. Liberals, who had countered by arguing that it would reduce unintended pregnancies, welcomed the decision but said the age restriction was unwarranted.

Doctors and researchers said they don't expect the decision to result in the worst-case scenarios of either side. Drawing from their own experiences with patients and from studies, they expect sexually active women who use birth control to stick with their current contraception method and most of those who don't to continue avoiding protection.

"I can't see them taking emergency contraception every time" they have unprotected sex, said Dr. Edward E. Wallach, a Baltimore gynecologist and Johns Hopkins University professor. Women who want to avoid pregnancy, he said, will likely take preventive steps.

How it works

The morning-after pill is actually two birth control pills, each taken orally. The first must be taken within 72 hours of unprotected sex and the second 12 hours later. According to the FDA, the pills work by stopping the release of an egg from the ovary, can prevent the union of sperm and egg and can prevent implantation of the egg.

Supporters of over-the-counter sales say the FDA approval will increase access to the pill by making it available on weekends or at other times when it might be difficult to reach a doctor for a prescription. Men will also be able to buy the drug for adult women, an FDA official said. The supporters predicted that the number of prescriptions, currently 1.5 million a year, would rise as awareness grows.

Sales could double

Annual sales of Plan B, projected at $38 million this year, should double, said Robert Uhl, a financial analyst at Friedman, Billings, Ramsey & Co. in Arlington, Va.

Still, that wouldn't mean that most of the nearly 43 million American women between 15 and 44 will buy Plan B. Almost 11 percent, or 4.5 million, don't use any method of birth control or contraception at all, according to the National Center for Health Statistics.

What's more, merely buying the pill doesn't mean that women always use it when they should, said James Trussell, the director of Princeton's Office of Population Research. He served on the advisory committee that recommended, on a 23-4 vote, that FDA approve over-the-counter sales.

Plan B, technically called levonorgestrel, has been available by prescription since 1999, and nine states have allowed pharmacists to dispense the drug without a prescription.

Trussell said studies of women with access to Plan B showed that it neither led them to have more sex nor meant that they used the pills as frequently as they should have.

"You're talking about a cork in the ocean here," Trussell said. "There's so much unprotected sex it would take a vast increase in use to make a difference."

Free publicity

The political controversy has given Plan B "a lot of free publicity. Many women who didn't know such a thing existed learned about it," Uhl said.

During the past three years, while over-the-counter sales were under FDA consideration, prescriptions jumped 130 percent, according to Barr Pharmaceuticals. However, the company doesn't expect Plan B to be anything more than one part of its array of 29 contraceptive products, according to a spokeswoman.

Gynecologists doubt their patients will abandon current birth control just because the government made an alternative more accessible.

"Most women are responsible and want to use protection prophylactically, in advance," said Dr. Nathan G. Berger, chairman of the gynecology department at Union Memorial Hospital in Baltimore.

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