Unfortunately, it's been approved for over 20 years now. They've always known about the birth defects, even when I was in the clinical trials they knew. The odd thing is, birth defects are preventable and are not a side effect to the patient taking the drug but a danger to the patients baby should they become preganant while on the drug or for years afterward. There was no mention of the skeletal deformities it can cause or the depression. In fact it wasn't until a State Senators son who was depressed and on Accutane had committed suicide that this big outrage started. Funny how nothing gets done about it until it effects someone in a position of power. Worst of all, depression from accutane is curable, unlike the birth defects and bone deformities. Does that make you feel like a second class citizen or what?