The recent partial government shutdown, which is now the longest in US history, has various stakeholders in the medical device and pharmaceutical industries concerned with the potential impact on the world of clinical research. The FDA is one of the federal agencies most affected, as the budget for fiscal year 2019 is on hold until the shutdown ends and Congress can appropriate funds. FDA Commissioner Scott Gottlieb recently tweeted that “The lapse in funding represents one of the most significant operational challenges in FDA’s recent history…It’s not business as usual at FDA. Many key functions aren’t getting done”. Approximately 40% of FDA employees have been furloughed since December 22nd due to the shutdown. The reduced staff at the FDA has been allowed to continue performing specific duties associated with the regulation of clinical research using funding generated from carry-over user fee balances that were paid in 2018. As part of the review process for new medical device registration applications, the FDA charges what is known as Medical Device User Fees . Each type of FDA submission has an accompanying fee that must be paid by medical device companies in order for an application to be reviewed, such as $10,953 for a 510(k), $11,275 for an Annual Report, or $322,147 for a Premarket Approval Application (PMA). Similarly, under the Prescription Drug User Fee Act (PDUFA), user fees are charged for the review and approval of new pharmaceuticals, such as $2,588,478 for a new drug application when clinical data is required. While the FDA has been able to continue to carry out existing reviews that were funded during fiscal year 2018, this cannot serve as a long term solution as these funds are finite. The FDA Commissioner has already cautioned that agency funds from PDUFA user fees may run dry within a month’s time and medical device user fees may be close behind with only two-three months of funding remaining. Below are additional impacts related to the shutdown.
No FDA acceptance of new applications or user fees. As long as the government shutdown is underway, the FDA is not legally authorized to accept any new medical device registration applications or human drug applications. The user fees that are collected in association with these submissions cannot be processed during a lapse period, and thus these submissions cannot be accepted until the agency is fully operational and funding appropriations are authorized. Applications meeting the criteria for the 510(k) and PMA processes that were submitted and received before December 22nd will continue the review process, but the FDA cannot accept any new submissions or user fees for fiscal year 2019 until the shutdown ends. Additionally, the FDA has halted reviews of Investigational New Drug (IND) applications and Biologics License Application (BLA) applications that are not funded by user fees. Depending on the length of the shutdown, this will undoubtedly result in a backlog of applications that will need to be processed, further delaying the lengthy process of bringing novel medical products to market.
Ceasing support for certain routine regulatory activities. The FDA has reported that it will be unable to support “some routine regulatory and compliance activities” and will also pause some “routine establishment inspections, cosmetics and nutrition work and many ongoing research activities”. The specifics of what this will entail have yet to unfold, but some potential consequences may include delays in FDA correspondence or in scheduling of FDA inspections. This could also impact arranged activities such as meetings between the FDA regulatory authorities and key stakeholders and will likely reduce overall access to agency infrastructure.
Delay in release of guidance documents. Over the past year, the FDA has been at the forefront of promoting the release of several medical device guidance documents planned for 2019. This includes topics such as the Breakthrough Devices Program, The Least Burdensome Provisions: Concepts and Principles, the Humanitarian Device Exemption Program, and the Special 510(k) Program to name a few. In addition multiple draft guidance documents are slated to be released in 2019 for public review and comment. Even when the FDA is fully operational, staff are often diverted from guidance development to more pressing activities, so the shutdown could cause postponements in both the release of guidances and processing public feedback on draft guidances. The shutdown could then further impact the FDA’s efforts in increasing transparency in order to get safe and effective medical devices to market more efficiently.
Possible delays in FDA approval decisions. As part of the user fee program that accompanies new drug and device applications, the FDA agrees to either approve or deny each application by a certain date. Some upcoming decision dates for new drugs are set to occur shortly after the FDA is projected to run out of funds.
The FDA has not currently released plans for when the money runs dry and whether this might affect decision timelines. The FDA is in the process of evaluating the current state of remaining funds and plans to release an update in the coming weeks. In the meantime, stakeholders in the medical device and pharmaceutical industry are left waiting for answers. One thing is certain, when the release of cutting-edge medical devices and novel drugs on the market is postponed; it is the patients in need of these treatments that suffer most.
What other long-term effects do you think the government shutdown could have on clinical research? And have you experienced effects of the shutdown on your clinical research?Closed Ranks via photopin (license)