FDA Commissioner Mark McClellan said the FDA would make a final decision on the morning-after pill in “a matter of months.” The agency usually follows advisers’ recommendations.
Asked whether political considerations would be taken into account, McClellan said, “We have a lot of information coming in. It’s very much a science-based process.”
The nation’s largest gynecologists group has pushed for the change in the drug’s status, saying it would greatly increase women’s ability to get the pills in time to prevent pregnancy. Although the morning-after pill is highly effective for 72 hours — cutting a woman’s chance of getting pregnant by up to 89 percent — it works best in the first 24 hours.
If used widely in the United States, emergency contraception could cut the number of unintended pregnancies — currently 3 million each year — in half and prevent hundreds of thousands of abortions, its supporters told FDA’s scientific advisers.
“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.
Reviews by the FDA’s staff found Plan B’s safety risks were “very limited” and posed no clear danger to a fetus if a woman was already pregnant, FDA reviewer Dan Davis said.
Those opposed to making the pill available over the counter argued that women and teenage girls use it in place of regular contraceptives. If it caused women to stop using condoms, they would increase their risk of getting sexually transmitted diseases, some opponents said.
“Over-the-counter availability of the morning-after pill will lead to increased promiscuity and its attendant physical and psychological damage,” Robert Carroll, a retired physician from Pittsburgh, told the panel.
After hearing testimony from both sides of the issue, the FDA’s advisers voted 23-4 in favor of allowing the Plan B morning-after pill to be sold over the counter.
A key consideration, the advisers cautioned, would be clear wording on the package so that women would understand that it should be used as early as possible, it does not protect against sexually transmitted diseases and should not be used instead of routine birth control.
Plan B manufacturer Barr Laboratories promised a massive consumer education campaign, including a 24-hour hot line for advice on using the drug.
FDA’s advisers were presented with a study of 585 women that found more than 90 percent correctly took the first dose of Plan B in time after reading the box. A second dose is supposed to be taken 12 hours later, and 73 percent took that dose on schedule. Most of the other women were a few hours off, although several of FDA’s advisers said that should not lessen the effectiveness.