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.
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FDA commissioner should be announced by mid-November and will likely continue to prioritize food and supplement safety, propelled by contaminants found in baby food, say two attorneys with Alston & Bird. A regulatory pathway for cannabidiol also is expected to be a priority once a commissioner is named.
After three panel members resign over agency’s approval of Biogen’s Alzheimer’s disease drug, the ‘billion-dollar question’ is why FDA provided so little information to justify use of beta amyloid as a surrogate endpoint, one panelist asserts, especially since the agency expressly disavowed the pathway during the advisory committee meeting.
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.