Panel Gives Morning-After Pill Nod

Women may soon have an easier way to help prevent pregnancy after unprotected sex now that government advisers have recommended that morning-after birth control should be sold without a doctor's prescription.

"It's extraordinarily safe," said Dr. Alastair Wood of Vanderbilt University, an adviser to the Food and Drug Administration.

In fact, he said, women probably should keep emergency contraception in their medicine cabinet just in case it's ever needed. "We don't tell people to buy a fire extinguisher after the fire started."

The panel on Tuesday voted in favor of over-the-counter sales of emergency contraception amid concerns from anti-abortion critics and worries from others that easier access to morning-after pills may increase unsafe sex, particularly among teenagers.

"We're very disturbed by Plan B's promoters' emphasis on access but not on women's safety," said Wendy Wright of Concerned Women for America, a conservative Christian group. "There have been no studies done on the long-term affects of women after taking Plan B."

But proponents argued there was no evidence that emergency contraception lulls women into complacency about regular birth control or disease. They said wider use of the morning-after pill could cut in half the nation's 3 million unintended pregnancies each year and in turn prevent hundreds of thousands of abortions.

"The name 'Plan B' was chosen in order to communicate to women this is plan B. Plan A is abstinence, family planning and routine forms of birth control," said Dr. Carole Ben-Maimon, president of Barr Laboratories, the manufacturer.

"There is a public health imperative to increase access to emergency contraception," said Dr. Vivian Dickerson, president-elect of the American College of Obstetricians and Gynecologists.

While the FDA usually accepts its advisors' recommendations, given the controversy surrounding contraception and abortion, approval is no certainty, reports CBS News Early Show Medical Correspondent Dr. Emily Senay. A decision is expected in late February.

Asked whether political considerations would be taken into account, FDA Commissioner Mark McClellan said, "We have a lot of information coming in. It's very much a science-based process."

The morning-after pill is simply a higher dose of regular hormonal contraception, and is sold by prescription under the brand names Plan B and Preven. Plan B's manufacturer wants to sell the drug without a prescription, putting it on pharmacy shelves next to the aspirin and cough medicine.

Taken within 72 hours of intercourse, the pills cut the chances of getting pregnant by up to 89 percent. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays, contraceptive advocates and the nation's largest gynecologists group told the FDA on Tuesday.

Morning-after pills prevent ovulation or fertilization, and possibly interfere with implantation of a fertilized egg into the uterus, the medical definition of pregnancy.

If a woman already is pregnant, they have no effect. Consequently, emergency contraception hasn't proved nearly as controversial as RU-486, the abortion pill.

It does have critics who oppose any interference with a fertilized egg, and who argued Tuesday during a daylong hearing that broader access could increase sexually transmitted diseases, especially in teens.

"Without medical advice, use of Plan B by teens will be disastrous," said Dr. John Bruchalski of the Catholic Medical Association.

Some of FDA's advisers did want teen access to nonprescription Plan B restricted, arguing there wasn't enough study of the drug in minors.

But the FDA responded that there are no age restrictions on prescription Plan B and that it couldn't enforce any on an over-the-counter version. Other advisers said teens in particular should avoid pregnancy.

The FDA asked its scientific advisers whether women could use the drug properly without professional advice. They could, the panel decided, voting 23-4 to recommend over-the-counter sales.

The key, they cautioned, would be clearer wording on the package so that women understand:

• The drug must be used as soon as possible after unprotected sex. Although it's effective for 72 hours, and possibly a little longer, it works best in the first 24 hours.
• Like other hormonal contraceptives, it does not protect against sexually transmitted diseases.
• It is a backup contraceptive, and should not be used instead of routine birth control.

Barr Laboratories promised a massive consumer education campaign, including a 24-hour hotline for advice on using the drug.

To improve access, California, Washington, Alaska, Hawaii and New Mexico already allow women to buy the morning-after pill directly from certain pharmacists without a prescription.

The FDA should not require pharmacists to dispense Plan B, most advisers agreed.