, 12 tweets, 2 min read Read on Twitter
THREAD - SHUTDOWN UPDATE: The lapse in funding represents one of the most significant operational challenges in FDA’s recent history. But as an agency, we’re committed to fulfilling our consumer protection mandate, to the best of our abilities, under our current configuration.
We analyzed activities with close input from senior career leaders & public health experts. Our plans always included activities to address immediate threats to human life & safety. But as lapse continues we’re evaluating additional activities we need to except to prevent threats
FDA determined after careful analysis and in close consultation with senior career leaders and public health experts that the following activities should be considered excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life:
The additional activities may be considered excepted work during a shutdown. Given the prolonged shutdown and compounding risk as time accrues; FDA is working to operationalize additional activities that exceed what we’ve done in past shutdown situations. Activities include:
Expanded inspection activities beyond “for-cause” inspections to also include foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest risk products and facilities;
Expanded monitoring and analysis by the Coordinated Outbreak and Response Evaluation (CORE) Network to include additional food safety and foodborne illness outbreak surveillance, detection, and response activities;
Surveillance sampling of imported high-risk foods, drugs, and devices, and the logistical coordination and laboratory support for allowable inspections and evaluation;
Expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices;
Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life;
These actions are being taken in close consultation with, and based on direct feedback from, senior career leadership of FDA, our program officers, and our range of experts. Our mission is focused squarely on securing consumer safety and protecting Americans during these times.
It is not business as usual at FDA. Many key functions aren't getting done. But we're focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission critical functions
In the coming days, we’ll update on some additional activities that the #FDA plans to continue undertaking, especially activities related to veterinary health issues that have a direct impact on human life and safety.
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