Congressional Action Needed To Protect Device Supply Chain, FDA’s Woodcock Says
The US FDA needs enhanced authorities as well as increased funding to track and prevent device shortages, acting commissioner Janet Woodcock argues.
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US President Joe Biden’s proposed budget for fiscal 2022 allocates $133.7bn for HHS, a 23% increase for the department from fiscal 2021; the administration is also asking for $6.5bn for the FDA, an 8% increase from the agency’s current budget.
A $2.2tn coronavirus stimulus package signed into law by President Trump on 27 March will distribute billions of dollars to federal agencies – including the FDA, the CDC and the FEMA – to hasten approvals of new diagnostics, medical ventilators, respirators and other medtech supplies, conduct more testing of potential COVID-19 patients, and quickly distribute medical supplies where needed most.
The resolution of a May 2020 warning letter to a breast implant manufacturer accounted for the only device-related close-out latter issued this month.