Federal judge throws out third-party Payor claim claiming preemption

The FDA is not competent to monitor the safety of drugs in the marketplace. The GAO wrote a clear and concise report reaching this and other conclusions in 2006. If FDA has inadequate resources and authority to ensure safety of drugs in the marketplace, because they cannot truly appreciate the evolving risks, then how can the FDA possibly be the final arbiter of an appropriate label? Not possible.
The preamble assumes the FDA actually knows what should be on product labels. The reality according to the GAO is much different.
FDA, by the way, agreed with the conclusions of the GAO, calling them reasonable. But FDA has had no comment, far as I know, about the GAO's recommendations for improving the system.