As we await the new version of the Kennedy/Enzi (nee, Enzi/Kennedy) bill and the debate over its half-brother PDUFA IV, it’s important to reflect on what “victory†looks like.
Consider REMS. On the face of it, certainly bad, but is it a go-to-the-mat issue? Many say “no.†Drugwonks says “yes.†Yes, because unopposed it allows the train to begin its journey in the wrong direction – and that means permitting momentum that will, in short order, lead to more dangerous policy ideas that will become even more difficult to derail. When it comes to bad ideas, there’s no time like the present to stop them in their tracks.
Consider advisory committee conflict of interest issues. A live-or-die proposition? Many say, “yawn.†Drugwonks says “yikes.†If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is, a significant disservice.
Kennedy/Enzi (or the inimitable Dan Troy refers to it, “Kenziâ€) is chockablock with unintended consequences that would significantly set back real FDA reform. Accepting Kenzi as a “least/worst†alternative (especially when the other option is the Dodd/Grassley abomination) represents not savvy political calculation but paralytic cowardice.
Who will step forward with the confidence and the credentials to lead the charge towards a more robust legislative endpoint?
Calling Dr. von Eschenbach ...
Consider REMS. On the face of it, certainly bad, but is it a go-to-the-mat issue? Many say “no.†Drugwonks says “yes.†Yes, because unopposed it allows the train to begin its journey in the wrong direction – and that means permitting momentum that will, in short order, lead to more dangerous policy ideas that will become even more difficult to derail. When it comes to bad ideas, there’s no time like the present to stop them in their tracks.
Consider advisory committee conflict of interest issues. A live-or-die proposition? Many say, “yawn.†Drugwonks says “yikes.†If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is, a significant disservice.
Kennedy/Enzi (or the inimitable Dan Troy refers to it, “Kenziâ€) is chockablock with unintended consequences that would significantly set back real FDA reform. Accepting Kenzi as a “least/worst†alternative (especially when the other option is the Dodd/Grassley abomination) represents not savvy political calculation but paralytic cowardice.
Who will step forward with the confidence and the credentials to lead the charge towards a more robust legislative endpoint?
Calling Dr. von Eschenbach ...
