2001P-0075 - Switch Status of Emergency Contraceptives from Rx to OTC
FDA Comment Number : EC793
Submitter : Ms. Arlene Cayer Date & Time: 06/10/2004 05:06:02
Organization : Northwest Community Hospital
Drug Industry
Category :
Issue Areas/Comments
The following is a comment made by Dr. Galson on Frontline last year:

What does 'FDA approved' mean? Does it mean that a drug is safe and effective, and that we shouldn't be concerned about taking it?

What it means when a drug is approved is that the risks are outweighed by the benefits for the indication and under the conditions that are in the label. That just means if the drug is used in the right patients, in the right way, at the right dose, and there aren't drugs that are contraindicated taken with it, that the benefits outweigh the risks. There's a lot that can go wrong that doesn't fit under that definition. But the benefits outweigh the risks for the indication and under the conditions of use that we specify when we approve drugs, and the public should feel very comfortable with the review process.

So we should feel comfortable with that phrase 'FDA approved,' that it really means something?

Absolutely. A tremendous amount of expertise has been built up here. We apply the most up-to-date scientific knowledge and tools to the data that we get from responsive companies. The public should feel very comfortable. But they also need to keep in mind that one, the system isn't foolproof, and two, there's no such thing as a totally safe drug. All drugs have risks, even over-the-counter drugs that are taken very commonly, like acetaminophen and aspirin. A lot of people don't understand that, and they need to [understand] that all drugs, over-the-counter [and] prescription], have risks.

I am disappointed with the recent decision rejecting approval for OTC status for Plan B post-coital contraception. Given the recent history of revisions regarding breast cancer and condoms, it looks like politics has overriden science at the FDA.