By now you've surely heard that the E&C vote on the FDA reform package was 39-0 and full House passage looks good.
But ...
The House version has some very dangerous language vis-a-vis advisory committee conflict of interest waivers. The House bill would only permit the FDA to grant one COI waiver per committee.
One? Why not two? Or three? What's the difference? After all, each adcomm member needs to be dealt with as a discreet case, yes?
We can't allow FDA adcomms to be made up of the second best and the almost brightest. Not ever.
Hopefully this can be resolved in conference -- and in the best interest of the public health.
But ...
The House version has some very dangerous language vis-a-vis advisory committee conflict of interest waivers. The House bill would only permit the FDA to grant one COI waiver per committee.
One? Why not two? Or three? What's the difference? After all, each adcomm member needs to be dealt with as a discreet case, yes?
We can't allow FDA adcomms to be made up of the second best and the almost brightest. Not ever.
Hopefully this can be resolved in conference -- and in the best interest of the public health.
