RMB,TTE, If a drug is approved for use by FDA, there is no restriction on how it is prescribed. FDA has no control over the practice of medicine. This is why Hatch Waxman is a failed amendment. Laws requiring generic substitution force a pharmacy switch to the generic, in violation of the branded companies patents. The issue is not about approval of an indication, but patents that cover the indication. This creates a legal problem. In theory Hatch Waxman solved the problem of "evergreening". The reality is that it moved the scale in the opposite direction. It did not achieve a balance. It creates a new imbalance. The SC has an opportunity to correct this poorly implemented legislation.
Sleven,
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