New Plans

AT FIRST GLANCE, the news that the Food and Drug Administration had decided to reject over-the-counter sales of the emergency contraceptive Plan B seemed dramatic. As we pointed out earlier this year, the science around this drug is not controversial. In several international studies, the drug has been shown to be safe and effective if taken within 72 hours of intercourse -- hence the request of its manufacturer, Barr Laboratories, to make it available over the counter. The FDA's own scientific advisory panel unanimously approved the request, and such a move would be popular. Most of the time, Plan B acts like a birth control pill, preventing ovulation and therefore conception: The greater use of Plan B therefore means fewer abortions.

But because Plan B may also prevent fertilized eggs from being implanted in a uterus, it has attracted negative political attention. Some of the drug's political opponents, those who equate a fertilized egg with a fetus, have called it an "abortion pill" and have lobbied the FDA hard to restrict it. Both state and national legislators have spoken out against the drug, partly on those grounds and partly out of concern for its impact on underage sex, leading many to fear that the FDA would make a political rather than a scientific decision.

In fact, though the FDA has banned the drug from over-the-counter use, it left open a window for future approval. "We weren't closing the door," said Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research. Indeed, if the FDA ruling is taken at face value, the only thing required of Barr is that it either conduct more studies of the drug's impact on younger women or come up with a plan to ensure that the drug is available only by prescription to girls younger than 16: According to Dr. Galson, the FDA was bothered by the paucity of data describing the impact of the drug on girls ages 14 to 16 and the absence of data on girls younger than that, some of whom might presumably try to buy the drug. The company says it is "months, rather than years" away from providing precisely such information.

The FDA is within its rights to remain cautious about a controversial drug. But if the agency wants to preserve its reputation for making decisions based on sound science, it will stick to this proposal and grant Barr the license to sell the drug as soon as the information or a suitable plan becomes available. At this point, the FDA should be given the benefit of the doubt -- but not indefinitely.