Industry Challenges FDA's User Fee Markup
This article was originally published in The Gray Sheet
During the first round of user fee negotiations, industry questioned FDA's estimated cost of $750 million needed to continue the device user fee program between 2018 and 2022. Lobby groups for the device industry continue to emphasize user fees should supplement congressional appropriations to pay for FDA's review of devices.
You may also be interested in...
The US FDA and industry stakeholders are set to finally start monthly user fee negotiations online by February. The process has already been significantly delayed due to the pandemic and recent holidays.
The agency and industry agreed to create working groups allowing subject-matter experts to delve deeper into technical details on some of the key proposals raised thus far in user-fee reauthorization talks. Areas of focus include de novo reviews, pre-submissions and personnel recruitment challenges.
As the number of de novo applications and pre-submission consultations keep growing, FDA is proposing to institute provide new funding for these programs, among a range of additional proposals laid out in a recent closed-door negotiation. The agency's plan aligns somewhat with an industry proposal, according to meeting minutes, but there is also a lot to negotiate.