ARTICLE SUMMARY:
A FDA user fee pause is averted as part of Congress’ action to avoid a government shutdown this week, but additional agency reforms will need to wait until December at the earliest. Meanwhile, a lawmaker makes a last-ditch attempt to get the Cures 2.0 bill, and potentially streamlined Medicare coverage for medtech, out of the gutter.
Congress has made a routine of passing eleventh-hour, short-term funding bills to avoid government shutdowns, a model it is following to a T this week as lawmakers inch closer to passing a continuing resolution that would fund federal agencies through mid-December before money runs out on September 30.
FDA user programs, set to expire on Friday, have avoided this type of emergency legislating in the past, but not this time around. Luckily, five-year user fee reauthorizations were able to hitch a ride on the continuing resolution this week, but device firms and other stakeholders will have to wait until December to find out if any additional legislative reforms are coming to FDA. Also: some fighting words on Cures 2.0. Here’s a quick roundup of the recent developments on Capitol Hill.
