Thursday, December 20, 2007

FDA to require contraceptives to contain new warnings

According to a press release issued today, the FDA is requiring a new warning on all over the counter stand-alone vaginal contraceptive and spermicidal products. This warning is to inform the public that the spermicide nonoxynol 9 doesn't prevent the spread of sexually transmitted diseases, including HIV.

While this, on the one hand, makes sense - the clinical studies in Africa and Thailand that the press release refers to did show that nonoxynol 9 can irritate mucus membranes, actually increasing the risk for a variety of infections. But on the other hand, do people actually commonly believe, again as the press release suggests, that nonoxynol 9 is an effective barrier against STDs? They very clearly are a contraception, but doesn't our STD education - or even separate HIV education - explain the concept of bodily fluids transmitting infection?

So I admit that while I am neutral on the new packaging (I don't have a lot of faith that people read the directions and warnings in any great detail), I'm sort of baffled with its justification.
-Kelly

1 comment:

J.E. Cochran said...

My personal issue with adding warnings to most bottles is the fact that, as Kelly pointed out, most people dont read warnings since there are too many of them.
The courts have recognized the prevailing system of over-warning and questions whether this over-warning in fact causes people to glaze over the issues.

The larger problem is what to do if you are the company: You will be sued if you dont warn. (even if the issue is obvious.) You will be sued if you do warn. (For over-warning) Most businesses lurk in legal limbo where most of them are not even sure if their actions are entirely appropriate.