Government Shutdown and FDA: Should Pharma Care or Not?
[Posted on: Thursday, January 25, 2018] Last weekend, the US government was shut down for two and half days and there is talk that another shutdown may happen in 3 weeks. Since such events are becoming more common than they ought to be, it is important for the FDA regulated industry to understand the impact of the government shutdown on FDA’s functions and any preparation to deal with these. FDA is a special Agency. First, it regulates critical functions such as management of public safety, therapeutic products and food supply much of which are exempt from shutdown meaning that much of FDA activities continue despite the shutdown. During a government shutdown, FDA continues to respond to medical emergencies, manages recalls of high-risk food and medical products, continues criminal and certain civil investigations, screens the food and medical product imports at US customs, and addresses any other critical public health issues that may arise during the shutdown period. Surveillance for safety concerns with medical devices and other medical products also continues. Second, FDA generates about half of its budget from user fees for the various services provided to the industry. These activities are not dependent on the government funding and hence continue during the shutdown. About 58% of the FDA personnel still report to work during the shutdown. So, the review of marketing approval applications and clinical trial applications continues. However, FDA is not allowed to collect new fees so new applications cannot be submitted. All FDA meetings such as pre-submission meetings with the industry and Advisory Committee Meetings scheduled during the shutdown period are rescheduled indefinitely till the government reopens and are delayed significantly. FDA personnel are not able to attend conferences and other public meetings. Any documents, responses, comments to applications are postponed. A big portion of FDA tasks are performed by contractors who are not allowed to work during the shutdown so the workload falls on the remaining FDA employees causing delays due to limited resources. The moment the government reopens, all activities resume and reschedule notices are sent, documents released, and relevant parties informed of the new dates. Since the last shutdown happened mostly over the weekend, the actual loss of work was probably only for about half a day. So, for all practical intents and purposes presumably the impact of this last shutdown was minimal at most. As would be obvious from the above, even prolonged shutdowns have limited impact on the FDA-regulated industry since most of the critical activities and fee-funded activities continue. So, should the FDA-regulated industry ignore the government shutdown? If you have a meeting scheduled with the FDA, are waiting for some critical documents or plan to make regulatory submissions, then sure you will be unhappy with the delays caused by the shutdown. But most other companies will likely keep working as usual.
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