There's a buzz in my inbox this week, about the FDA preemption issue, mainly because, as we draw nearer to the court's decision on Wyeth v. Levine people are beginning to ask what this all means and how it will affect the biomedical industry. According to some, FDA preemption of state product liability actions will change how everything is done down the pipeline, from new product submissions to manufacturing and labelling. That makes perfect sense, but the question is...is that such a bad thing? Those in favour believe it will offer added protection to the consumer (patients), but Congress is opposed and will try to curb the Supreme Court's decision to uphold preemption (if it does) by introducing the Medical Device Safety Act (H.R. 6381).