it is not a big secret that FDA managers have been forbidden for asking for more resources or requesting additional regulatory authority. There was an interesting comment in Dickinsons from a senior manager in ORA who was "advised" by HHS/OMB not to ask for resources.

But--I think the closing note in the NEJM piece was important. Even if Congress appropriates the funds and gives the authority, that doesn't mean the goofballs running the agency will use the money and authority appropriately.

There is no question that the FDA has been muzzled for the entire period of Bush's two presidencies, a pattern noted in other regulatory agencies as well. Just ask Representative Henry Waxman, or Senator Charles Grassley, or Dr. David Graham about it. Take a gander at when the FDA gets around to requiring a black box warning: It is always a coupleof years after other Westernized countries. Tamiflu, just recommended for a warning, is a perfect example. Another was Zyprexa - two years after the UK and Japan.

The recently enacted "reform" was stripped like an ear of corn of its most critical safety features. Congress could barely get into their offices, having to fight their way through the throng of Pharma lobbiests. Who knows how much Bush's boys had to do with it but since they love Pharma, I'm sure that they had their say as well.

It is a hopeless agency. I wonder if it can be redeemed with a new administration.

Can someone explain to me why Waxman, Grassley, et. al. supported FDAAA? Art of compromise? Getting at least something?

I have argued that this "something" is worse than nothing in that it will delay anything resembling genuine reform. I would love to have my mind changed.

It would seem they ran out of time on negotiations and there are things in there that were in the spirit of what reformers have wanted. Reformers want increased ability to compel Phase IV trials, increased focus on postmarket surveillance, increased disclosure of trial results... etc...

but don't count on any real reform as long as the executive branch owns and runs FDA and the opponents of reform run the executive branch. Improvements are going to be incremental and the pressure will continue.

Also...it should be noted that just because HHS and OMB have attempted to muzzle senior managers and have populated management positions with stiffs doesn't mean that Congress doesn't already know what is going on and what needs to be done.

Several important people have left the agency over the last few years and they are certainly not prohibited from talking to Congress. A good case could be made for the ex-employees knowing more about the state of FDA and what needs to be done than do those fronting for the agency now. Actually, in reading the piece by Bill Schultz, it struck me how clearheaded it was and how the agency used to be run by smart articulate people with a sense for how things worked... and that no one currently fronting for the agency could have written something like this.