Living with the Shutdown: What’s Still On at FDA and What’s on Hold.
​[Thursday, January 10, 2019 ]

With the US government partial shutdown completing its 20th day, it is important for the regulated industry to understand that despite the event, many activities at the FDA continue as normal (as much as one can define “normal”). First, the things that don’t change. Pharmacovigilance activities continue as normal. Companies are still expected to report all serious adverse events, and the FDA staff involved with their review still responds. Import alerts and product recall activities are not impacted as are the activities related to inspection of imported products at the ports of entry. The ongoing marketing approval application review process also continues as normal because it is fully funded by the user fees. There have not been any delays reported in the approval decisions since the shutdown began; a review of FDA’s product approval pages indicate no reduction in the number of product approvals. The clinical trial activities for ongoing clinical trials also do not go on hold. Clinical trials under IND and IDEs continue as planned with safety reports submitted to and reviewed by FDA as normal. Also, submissions to the electronic submission gateway (ESG) are not impacted. Although the ESG is managed by several contractors, much of the ESG is automated hence one can still submit documents to the ESG. The FDA inspection activities are also, by all reports, ongoing as planned. FDA inspectors may still show up at your facility to conduct an audit, however, the frequency of surveillance inspections is expected to slow down, with the FDA focusing its resources on for-cause and safety related inspections. The industry is still expected to stay compliant to all applicable regulations; any non-compliance activities during the shutdown are expected to be pursued with similar vigor. Of course, there are some activities are either suspended or slowed. New applications submitted to the FDA are either delayed or not accepted for review. IND and IDE applications that do not require a fee can be submitted to the ESG, but their review may be delayed. FDA will not be able to accept any new regulatory submissions that require a fee payment, so new market approval applications (NDA, ANDA, BLA, BsLA, 510k and PMA) cannot be submitted. Similarly, FDA is unable to process user fees for other activities such as establishment registration. Since the shutdown happened in late Dec, any establishment registration fees paid in the last few days of the year, could not be processed. However, the facilities are allowed to continue operations with the expectation that user fees will be accepted immediately upon the opening of the government. Companies can still submit their fees to the pay.gov website but will not receive the PCN needed for proceed further with their online registration. However, FDA announced today that it will run out of the user fee funds in 1-3 months which may trigger major austerity emergency measures. FDA employees are working without a pay check these days which could create additional hardships to continue operations. The longest shutdown was for 21 days in 1995 and FDA was very different almost 25 years ago. No one knows what could happen if the shutdown goes on a longer than a month. So far industry is not affected majorly. Hopefully the shutdown will be over, before that changes.