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Women who are worried about getting pregnant will soon be able to buy emergency contraception without a prescription.
The U.S. Food and Drug Administration approved the drug, called Plan B, for over-the-counter use on Thursday, although women still will have to ask a pharmacy for it and the change is not expected to occur until the end of the year. The move came after three years of controversy over manufacturer Barr Labs' application.
Karrie Galloway, director of Planned Parenthood Utah, lauded the FDA's decision but was wary of the restrictions, such as a ban on sales to women under 18 without a prescription.
"I'm thrilled that after three years the FDA has finally accepted that it's medically safe for women," Galloway said. "Unfortunately, this ruling has a number of caveats. Women under 18 don't have access to it over the counter. And many pharmacists put their own judgment on whether a woman is worthy of medication that is sexually related."
Galloway also pointed out that women in rural areas will have more trouble obtaining Plan B because their pharmacies often have limited hours.
In urban areas, residents can go to Walgreen's, which carries the drug and has some stores open 24 hours a day. Walgreen's will make it available over the counter as soon as it is allowed, corporate spokeswoman Carol Hively said.
Wal-Mart is waiting for more details about Thursday's approval, company spokesman Kevin Gardner said.
"Once we have those details, we will consider carrying the product for [over-the-counter] sale," Gardner said via e-mail.
Wal-Mart began selling prescription Plan B in March - after years of refusing to - in response to at least one state's mandate. Earlier this year, Massachusetts' pharmacy board required stores statewide to carry the drug after several women complained about having their prescriptions refused.
Albertsons also will wait for additional information from the manufacturer before deciding how to proceed, according to a company statement.
The debate over the effectiveness and moral implications of Plan B, available by prescription since 1999, has raged for years. But the arguments had recently shifted to whether pharmacists could raise their moral objections to the medication as a reason for refusing to fill Plan B prescriptions.
Utah's Division of Occupational and Professional Licensing's Pharmacy Board said it has received complaints about Utah pharmacists confiscating prescriptions for Plan B.
At Walgreen's, pharmacists who object to selling the drug on moral grounds will be required to call their store manager so that another employee can assist the customer.
"We can't force our pharmacists to violate their moral or religious beliefs," Hively said. "But now that it will be available nonprescription, it doesn't have to be a pharmacist who sells it."
Pharmacy technicians or even store managers will be able to make the sale.
"Our intention is to sell it to every customer and not send them away without it," she said.
Plan B consists of two progestin pills taken 12 hours apart. Depending on when it is taken, it works by preventing ovulation, fertilization or implantation of a fertilized egg in the uterus wall. It can be used up to 72 hours after intercourse, but its effectiveness fades with time.
Joseph Stanford, a family physician with the University of Utah Hospital & Clinics, was one of four members of the FDA advisory panel who voted against allowing over-the-counter sales of Plan B. A specialist in natural birth control, he said possible health effects from repeated use of Plan B are unknown.
It contains a high dose of a synthetic progestin hormone found in traditional birth control pills, which can cause blood clots in certain people, especially smokers.
Stanford, who no longer is on the panel, also questions whether wider availability will diminish personal responsibility and increase the incidence of sexually transmitted diseases.
"What I'm concerned about is its general affect on sexual behavior," he said. "Some people might alternate their behavior to be less responsible because they think they have a backup."
Conservative groups blasted the FDA.
"Unfortunately, the responsibility for the deaths of an untold number of preborn children rests on the shoulders of our federal government," Judie Brown, president of the American Life League, said in a statement.
Activists have called for over-the-counter sales of Plan B to ease the burden on women who have been raped, had a contraception failure or had unprotected sex. Each year, millions of women face the prospect of an unwanted pregnancy; there are about 3,500 abortions in Utah annually, according to state statistics.
"Our experience at the Rape Recovery Center is few victims report their assaults to law enforcement officers," said Heather Stringfellow, of the Rape Recovery Center in Salt Lake City. "Certainly, having emergency contraceptives available without a prescription that someone could buy quickly is key. It's better; it's a step in the right direction. But I think some of the restrictions are prohibitive."
Explaining Plan B
A summary of the morning-after pill, Plan B, manufactured by Barr Pharmaceuticals Inc.
How is it used? If taken within 72 hours of unprotected sex, it can lower the risk of pregnancy by up to 89 percent.
What is it? A high dose of a drug found in many regular birth-control pills.
How does it work? It is not an abortion pill. It prevents ovulation or fertilization of an egg; it also may prevent the egg from implanting into the uterus, though recent research suggests that's unlikely. It has no effect on women who are already pregnant.
Who can buy it? Under the new FDA approval, women age 18 and older will be able to buy it by the end of the year without a prescription. Those 17 and younger would still need a prescription.
How available will it be in Utah? Walgreen's has committed to selling nonprescription Plan B as soon as it is available. Wal-Mart is awaiting additional details on the FDA approval before deciding whether to offer the drug over the counter.
What do supporters and critics say? Advocates say it can cut in half the 3 million unplanned pregnancies that occur every year in the United States. Opponents fear wider access to the pill could promote promiscuity.
- Associated Press and Tribune reporting.
What's next:
* The Food and Drug Administration's lengthy delay in deciding on Barr Pharmaceuticals' application ensnared President Bush's nominee to head the regulatory agency, Andrew von Eschenbach. On Thursday, two senators said they would lift their block on his nomination, making it likely he will win confirmation as FDA chief, perhaps next month.
* Manufacturer Barr Pharmaceuticals, lawmakers and other advocates said they will still press the government to let minors purchase the pills over the counter.
* Barr Pharmaceuticals expects the pills to be available to adult women over the counter by the end of the year.