Compliance In Focus

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.

Recently the FDA released an announcement outlining plans to further modernize the 510(k) clearance pathway. This briefing falls in line with the latest efforts by the FDA to promote and improve safety and effectiveness in an efficient manner. The current 510(k) framework, which has been in existence since the 1976 Medical Device Amendments will undergo some much-needed updates in the near future to adapt to the ever-evolving medical device landscape. The FDA has already taken steps this past year to begin the transformation process, including the release of a draft guidance regarding the abbreviated 510(k) program. Additionally, the agency recently shared a “performance report” describing various measures implemented in the last 10 years to improve the 510(k) pathway, with a spotlight on recent efforts. These actions taken by the FDA include: