Shutdown and Impacts on U.S. FDA Averted For Now
It was not quite the 11th hour, but close to it.
A compromise was reached on a short-term stopgap bill to continue funding the U.S. government. Unfortunately, this only buys a little time, providing funding through the 17th of November 2023. We are monitoring the situation in Washington, DC, and will continue to take the necessary steps to minimize impacts on our clients, their submissions, and other business before the FDA. We encourage you to reach out to us with any questions.
We are also assessing the recently announced rule proposed by the FDA regarding LDTs. We’ll have more to share regarding the potential impact on IVD manufacturers and LDT providers soon. Our Regulatory team looks forward to your questions and providing further insight on this crucial topic.
Key Points Regarding a Shutdown:
Adapted from our earlier letters to clients
During a government shutdown, the U.S. FDA operates under a contingency staffing plan issued by the Department of Health and Human Services.
Despite outlining a number of activities that can continue, it is not known how limitations imposed by a government shutdown would affect operations, review timelines, and the responsiveness of the FDA.
The plan states how “user fee work specifically supports the review and approval of new medical products, the review of requests to conduct important clinical research, the issuance of guidance, and other necessary activities to help patients have access to new therapies and important generic and biosimilar treatment options.”
Assessing the potential impact of any lapse in funding on the U.S. FDA depends greatly on the duration of the shutdown.
510(k)s and other premarket submissions currently under review (if user fees were paid) are not expected to be impacted.
In contrast, review timelines for Q-submissions (Pre-submissions, Breakthrough Device Designation, etc.) that have been submitted are expected to be impacted.
Additionally, new applications for marketing authorization with outstanding user fee payments are not likely to be accepted for submission during a government shutdown.
At a glance —
The impending government shutdown and potential impacts on the U.S. Food and Drug Administration (FDA) have been averted by a short-term stopgap bill.
The short-term measure is expected to provide funding through November 17, 2023.
FDA recently announced a new proposed rule regarding Lab Developed Tests or LDTs. Check back for more regarding the rule’s potential impact on IVD manufacturers and LDT providers.
How does a shutdown affect staffing at the FDA?
If a government shutdown is initiated, the FDA will immediately need to furlough approximately 20% of its staff until it receives more appropriations to fund the Agency. This reduction in staff will impact the efficiency of FDA review teams and their ability to complete reviews per performance goal timelines. However, the true impact on FDA availability and how this will translate to reductions in efficiency is unknown at this time.
Will the FDA continue to review submissions during a shutdown?
As described in the FY24 HHS contingency plan, activities likely to continue include user fee related work such as review and approval of new drugs and devices with carryover user fee funding. However, no new user fee payments are accepted during a shutdown. Therefore, marketing applications with outstanding user fee payments will not be accepted for submission during a government shutdown.
Additionally, work on emergency use authorizations (EUAs) related to COVID-19 would continue with the COVID-19 supplemental funding.
Finally, all vital FDA activities related to imminent threats to the safety of human life will also continue.
Continue to maintain a Readied Stance.
Our team at MDC Associates has worked with the FDA for over 35 years, corresponding on behalf of our clients and maintaining positive, productive relationships.
We’ve navigated previous shutdowns with the agency and our clients to mitigate challenges like this when they happen.
During prior shutdowns (2018-2019) some online systems and services of the FDA experienced interruptions as agency personnel were not always available to respond to online inquiries. With more submissions moving to electronic platforms, this could have a greater impact today than it did four years ago.
It’s important to be prepared should a funding solution not be passed before November 17, 2023.
We continue to actively monitor developments to keep clients prepared ahead of any likely impact on the FDA.
Are you working on a submission to the FDA?
Help is standing by.
Let’s carve out a detailed, sensible plan that propels your product’s journey to market. And then let’s execute it —together!