Assuming that Kenzi is passed without amendments that make medicines less safe -- meaning importation or follow-on biologics -- the current bill will give FDA tons of money for new tools to monitor drug risks post market.
That should put the pressure on the agency and its overlords in Congress to allow medicines with targeted risk benefit profiles on the market right? (We know who is running the show absent real leadership at the FDA.) After all if we put REMS in place because all risks are unknown during and after a clinical trial, the same can and is true about benefits, nes pa? And who is to say whether the collective benefits are less important than the collective risks? Shouldn't patients in a subpopulation make that decision or do FDAers, the media, Hill staffers, etc in their infinite wisdom know in advance for everyone who will benefit and who will be harmed with such precision that they should be entrusted with making decisions for everyone else. Or are these REMS tools just for show?
That should put the pressure on the agency and its overlords in Congress to allow medicines with targeted risk benefit profiles on the market right? (We know who is running the show absent real leadership at the FDA.) After all if we put REMS in place because all risks are unknown during and after a clinical trial, the same can and is true about benefits, nes pa? And who is to say whether the collective benefits are less important than the collective risks? Shouldn't patients in a subpopulation make that decision or do FDAers, the media, Hill staffers, etc in their infinite wisdom know in advance for everyone who will benefit and who will be harmed with such precision that they should be entrusted with making decisions for everyone else. Or are these REMS tools just for show?
