FDA may give Pharmaceutical companies some discretion in labeling.

Implications: How will the legal community react to the FDA giving Pharmaceutical companies some latitude in labeling? Even with Strict FDA Guidelines on discretionary changes in labeling will this open the floodgates for consumer & legal issues? Will even some latitude in Pharmaceutical labeling be the rope to hang some companies?  

Analysis: Giving pharmaceutical companies a blessing by the FDA to make certain unilateral changes to labeling may come back to haunt the FDA.  Companies may then attempt to use this as a defense that big brother said it was acceptable so we should not be held responsible.  On the other hand cutting out the red tape on certain rudimentary changes may be a more cost effective & efficient way to handle this process.  Would it result in lower overhead which would be passed along to the consumer in savings or at least less continual price increases, one doubts it! The other issue is how this would possibly affect preemption, FDA essentially usurping state laws, which Plaintiff's lawyers definitely do not like. One should thoroughly understand preemption to be in the best situation to opine one way or the other as preemption has some interesting concepts & interpretations. http://www.law.umkc.edu/faculty/projects/ftrials/conlaw/preemption.htm