After weeks of the government’s shutdown, the US Food and Drug Administration (FDA) has announced that more workers will be returning to work without pay.
A large majority of these workers are inspectors or work to support inspectors.
Scott Gottlieb reports:
“We wouldn’t have conducted inspections during the 2 weeks around Christmas and New Years, so this is really the first week where there might have been ‘some’ inspections postponed while we put in place mechanisms to continue high risk food surveillance inspections during shutdown… I’m getting the total number of inspections, out of the 8,400 we do each year, that were postponed this week. It may be a few dozen but not much more. So reporting we ‘stopped’ really means reporting we didn’t do 20+/8,400 on time,” Gottlieb tweeted.
Around 400 staff members are returning and of these, about 100 will focus on high-risk medical device manufacturing facilities, about 70 will concentrate on the inspection of high-risk drug manufacturing facilities, and about 90 will deal with high-risk biologic manufacturing site inspections. The remaining staffers are to report on food inspections.
In addition to inspections, more activities are to be carried out after careful investigation and close deliberation with senior FDA leaders and public health experts. These activities include:
- Expanded inspection efforts beyond those needed due to a specific problem, focused on the highest-risk products and facilities of foreign and domestic food, drugs and medical devices;
- Surveillance sampling of imported high-risk foods, drugs, and devices, and the operational coordination and laboratory guidance for those inspections and evaluations;
- Increased monitoring and evaluation of adverse events and malfunction reports of medical devices to include more types of medical devices;
- More projects related to the surveillance and response for recalls, notably those of Class 1 and Class 2 medical devices, as needed to analyze and classify threats to patient safety.
Furthermore, the FDA also announced that funds will be moved around to attempt to better surveil pharmaceuticals rather than to work on drug applications.
Since the shutdown, one company, Aimmune Therapeutics, has announced in an SEC filing that the FDA will not be reviewing its biologics license application. More dismissals are expected to ensue the longer the shutdown and the lapse in funding continue. However, some drug reviews will continue only for the next five weeks, at which point funds for these reviews will run out.
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