Giovanni...yes, and I've read somewhere that the FDA must recall 2,500+ (maybe this is a little high) drugs every year due to risks of injury. One may ask .... how does this happen? IMO, this happens because of PDUFA. The FDA receives $$$ (PDUFA fees) from every drug that is approved and sold on the market. This is a conflict of interest, and provides the FDA with an incentive to approve drugs that should have never been approved. These fees also result (IMO) in the FDA being biased towards the BPharmas that will generate the highest PFUFA fees....leaving the little biotech (ex: RVVTF, RLFFD, etc) out of the equation.
PDUFA fees came about so as to provide the FDA with $ resources to help expedite the approval of drugs (a good thing for consumers). But instead it's just provided a vehicle for corruption.
Congress should end PDUFA fees, thereby remove the incentive for corruption. IMO RVVTF is too small to generate a enough PDUFA fees to get the attention of the FDA. JMHO
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