First, a correction that you will not see in the Gray Lady:
The Times writes that PDUFA fees â€œhelp finance the approval process â€¦â€
True, but not accurate. PDUFA fees finance the review process. A trivial, rhetorical difference? Certainly not.
So whatâ€™s the big deal where the money comes from? Two big reasons:
(1) Reality. Does anybody even remotely familiar with the funding history of the FDA really believe that Congress is going to fund the agency at anywhere near appropriate levels? Indeed, if history is any guide, the reverse would occur.
(2) Alacrity. With PDUFA fees come PDUFA dates. Is our short-term memory so bad that we have already forgotten the shameful days of the â€œdrug-lag?â€ Yes, folks â€“ it was real.
And to add to their revisionist view of pharmaceutical regulation, the New York Times agrees with many of the agencyâ€™s critics that, if only the FDA worked harder, they could replace â€œconflictedâ€ advisory committee members with ones equally talented and more pure.
Ladies and Gentlemen â€“ mediocrity is not an option.
When legislators try to rewrite history we suffer the inevitable consequences.