As the partial government shutdown drags on, the backlog of unreviewed FDA submissions continues to grow. On Thursday, AdvaMed unveiled a proposal to help chip away at the submissions.
The proposal calls for FDA to continue processing new applications and the associated user fees under the Medical Device User Fee Act (MDUFA). Because of the shutdown, FDA cannot accept these user fees to process new applications.
AdvaMed gave some scope of the problem noting that there are roughly about 300 device applications that are submitted to FDA in a month. Roughly 295 of those are 510(k)s and the remaining 10 are split in half between de novo and PMA applications. The group noted the submission backlog could get out of hand pretty quickly if the issue continues to drag on.
“Right now, Centers for Device and Radiological Health (CDRH), as I understand, it is using existing user-fee carry over balances to support staff and review submissions,” Scott Whitaker, president and CEO of AdvaMed, said during a call with media. “But those submissions they are reviewing are only the submissions that would have been sent in or received by FDA prior to the shutdown. None of the new applications … that have come into FDA in the past month are being reviewed now.”
AdvaMed’s measure is also asking legislators to authorize FDA to tap into its pool of “unearned” user fees to fund device review activities during a lapse in appropriations.
Every year, a number of companies essentially “pre-pay” application or facility registration fees to the agency, and for whatever reason, never submit an application or register a facility. While FDA eventually tries to return these fees or “save” them to pay a company’s future fees, these “unearned” fees often just sit in the agency’s account, not dedicated to any specific task. AdvaMed said these at the end of FY 2017 the fees amounted to $7.5 million.
As it stands now the carryover balances from the device user fee would run out in about another two or three months. Whitaker noted that three months is the “best case” scenario.
AdvaMed said it began having conversations with Congress earlier this week about the proposal. The agency remained tight-lipped about the specific legislators that had seen the proposal and their reactions.
“We’re not assuming this helps resolve the government shutdown in any form and we’re not getting specific intelligence from anyone who says there is a specific vehicle moving in the next week,” Whitaker said. “But what we are trying to do is anticipate what appears to be a protracted government shutdown … and anticipate the possibility that Congress resolves smaller issues where there’s unity. If that situation arises we want to make sure that we’re in the que for that conversation.”
FDA has also been hit across the board and has even stopped most of its food inspections. The agency said it will resume some inspections, but that would require workers to come in without pay. In the meantime, the country as well as the medtech industry is holding its breath for the matter to be resolved. Whitaker said there is a great sense of uncertainty in the medtech industry right now.
“There’s a long and protracted process that companies go through to get a product queued up for FDA, and they’ve gone through that process,” Whitaker, told MD+DI during the call. “It’s difficult for [medical device companies] when they have hit a wall and face the uncertainty of when a user-fee program that we’ve all agreed to isn’t operational. It complicates a company’s operations significantly not to mention the impact it has on the patients or health systems who might be waiting for a new product.”