Aduhelm Approval Raises Concerns About US FDA Leadership, Senate Finance Chair Suggests
Executive Summary
Ron Wyden points to expectations Biogen’s drug will impose a heavy cost burden on Medicare as he questions FDA’s decision to approve aducanumab. He also expresses interest in a government-sponsored technology assessment program that could help establish the value of drugs.
You may also be interested in...
‘Embarrassing About-Face’: FDA’s Aduhelm Labeling Change Does Little To Improve Frustration Over Alzheimer’s Approval
US FDA’s update to Biogen’s Aduhelm label was the right move, drug policy experts say, but that doesn’t mean the agency should expect a round of applause. Instead, they expect it will only heighten the controversy and tension over the unexpected June accelerated approval of the pricey new Alzheimer’s disease drug and could further erode trust in the agency. The updated indication, which emphasizes initiating treatment in patients with mild disease, still gives plenty of wiggle room for wider prescribing.
Like Sands Through The Hourglass, So Are Janet Woodcock’s Days As Acting FDA Commissioner
Janet Woodcock has been a no-nonsense acting commissioner, but there’s plenty of drama in the nomination process as opposition and support for her to become permanent head of the US FDA continues to mount while the wait for President Biden’s nominee drags on.
Like Sands Through The Hourglass, So Are The Days Of Woodcock’s Acting FDA Commissionership
Janet Woodcock has been a no-nonsense acting commissioner, but there’s plenty of drama in the nomination process as opposition and support for her to become permanent head of the US FDA continues to mount while the wait for President Biden’s nominee drags on.