With only about two or three months left of medical device user fees, AdvaMed has drafted a new legislative proposal aimed at continued US Food and Drug Administration (FDA) reviews.
AdvaMed CEO Scott Whittaker and head of regulatory affairs Janet Trunzo discussed the legislative proposal during a conference call with reporters on Thursday. The industry group began discussing the proposal with members of Congress earlier this week, Whittaker said.
The proposal seeks to address the inevitable backlog of premarket submissions to FDA’s Center for Devices and Radiological Health (CDRH) because of a government shutdown by ensuring the work on applications continues, and that patient access to medical technologies is safeguarded. The proposal comes as the US faces the longest government shutdown in history.
Whittaker noted that CDRH has historically received about 300 applications for devices in just one month. These include 290 510(k) submissions, five premarket approval applications and five de novo classification requests on average. But “the longer the shutdown goes on, the more and more the backlog will build up and for us, that is a real concern,” Whittaker added. This is because FDA cannot accept user fees in a shutdown so any new submissions “just sit there.”
As a result of the lapse in appropriations, several from FDA
and industry have estimated that CDRH will run out of Medical Device User Fee Amendment
user fees within two months. The best case scenario for these funds is three months, Whittaker argued.
The industry group’s proposal is two-fold. The first component of the proposal relates to allowing the agency to “continue processing new device applications and their associated user fees during a lapse in appropriations,” whereas the second calls for enabling the agency to “tap into” an existing pool of unused user fees for continued user fee-related work. “These fees accumulate each year and at the end of FY 2017 amounted to $7.5 million,” AdvaMed said.
Howard Sklamberg, a partner at Akin Gump Strauss Hauer & Feld, discussed some additional details around FDA’s budget during a live webinar hosted by the Food and Drug Law Institute on Thursday.
Based on his past experience as an FDA compliance director during the government shutdown in 2013, Sklamberg argued that user fee funds “are quite fluid” compared to appropriations in place and the “lines are somewhat difficult to draw” so FDA “is probably prioritizing the work that it can do” regarding user fee programs. FDA is going to have a lot of submissions to deal with after the shutdown is over and this is going to impact how backlogged devices will be evaluated over time, Sklamberg said.