Sen. Burr’s Parting Gifts For US FDA Include ‘Platform’ Pathway
The year-end package of US FDA reforms reflects the impact of one now-retired US Senator: North Carolina’s Richard Burr’s objections helped take out a number of ‘anti-innovation’ provisions – while still securing inclusion of a ‘Platform Technologies’ pathway that might otherwise not have been enacted.
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President Biden has selected a new director for the US Centers for Disease Control and Prevention, and the pick – former CMS official Mandy Cohen – is likely to be the last who is not subject to confirmation in the Senate. That is an important nuance in the current political climate for drug pricing policies.
The omnibus spending bill included dozens of reform provisions related to the US FDA. One seemingly minor change to FDA’s inspection authorities could end up being a big help to the challenges ahead in catching up after the COVID-19 pandemic.