round after round of testing a promising new drug, at this time you have spent at least 200 million dollars on this drug (conservatively speaking). You are getting close to approval. Then the FDA decides to pull the plug. On a technicality. A paper work error. All of the money is flushed down the drain. If you aren't bankrupt, you get to start from square one. That is what happened to a client my firm had. So, when you say you don't have to prove anything to get approved, that simply is 100% wrong. The opposite is true. You have to prove everything. 10x's over. If anything, I believe we should streamline the approval process. This is also part of why drugs are so expensive.