FDA Approves Plan B Contraceptive Pill Without Prescription

JEFFREY BROWN:

The Plan B contraceptive is designed to be taken within 72 hours after unprotected sex, thus its popular name, the morning-after pill.

The pills, manufactured by Barr Pharmaceuticals, are a concentrated dose of the hormone used in regular birth-control pills and have been shown to lower the risk of pregnancy by up to 89 percent. Plan B was approved for prescription use in 1999, but a push to make it more widely available has been highly contentious, including within the Food and Drug Administration itself.

Top officials there overruled an opinion by staff scientists that non-prescription sales of Plan B would be safe for all ages. Later, several Democratic senators refused to move ahead with the confirmation of the Bush administration's nomination of Andrew von Eschenbach as new FDA chief.

Things changed last month when von Eschenbach, on the eve of a hearing, said the FDA would consider over-the-counter sales of Plan B. And today, the agency gave formal approval, but with important limits.

Here to tell us about it is Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. He's played a key role throughout the decision-making process. Welcome to you.

DR. STEVEN GALSON, FDA's Center for Drug Evaluation and Research: Good to be here.

JEFFREY BROWN:

Why, after all this contentious delay and this fight, have you now approved Plan B?

DR. STEVEN GALSON:

The Food, Drug and Cosmetic Act requires us to make a certain assessment of the strength of the scientific information before approving a switch of a drug from a prescription status to the over-the-counter status.

We have to demonstrate — the companies have to demonstrate and we have to judge whether the drug can be taken by someone without the intervention of a physician, whether they can follow the instructions and take it the way that it's supposed to be taken and it ends up being safe and effective.

JEFFREY BROWN:

Now, the key distinction you have drawn is this age?

DR. STEVEN GALSON:

That's right.

JEFFREY BROWN:

Why approve it only for those 18 and over?

DR. STEVEN GALSON:

Right. We were concerned that, when we saw the information that came into us having to do with the tests on the drug about whether people could use it correctly without prescription, that there wasn't enough data demonstrating that young people could follow those instructions. I think that the pediatric and adolescent age group is a separate entity.

They require separate, different, perhaps, types of information to show that adolescents can take the drug without the intervention of a physician as opposed to adults. They behave differently, and it seemed intuitive to me.