With the ongoing government shutdown, the FDA is likely to have increasing trouble meeting its commitments, according to medical device industry analysts at GlobalData. That spells trouble for companies such that are scheduled for FDA panel meetings in coming weeks, and it could "spook" investors, GlobalData warned.
The FDA’s Circulatory System Devices Panel is scheduled to meet this week to discuss expanded indication for a fleet of Medtronic (NYSE:MDT) cardiac implants and to consider CardioMEMs’ Champion HF patient monitoring system. That meeting is still on the docket, according to the FDA’s website, but others have been taken off the books.
Already sacrificed is the October 7 public workshop run by the FDA’s Center for Biologics Evaluation & Research, the FDA said. No additional details or postponement dates were provided.
The federal watchdog agency lost about 45% of its staff to furloughs, amounting to some 40,500 workers, according to a memo from the Dept. of Health & Human Services. The agency is also no longer able accept new applications for medical devices or drugs, as it’s not able to collect the user fees companies usually pay for review of new products, according to an FDA memo.
"FDA would continue limited activities related to its user fee funded programs including the activities in the Center for Tobacco Products," according to the notice. "FDA would also continue select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues."
That leaves routine facility inspections, import monitoring, notification programs and other duties by the wayside, but certain medical device and drug responsibilities remain funded by user fees that the FDA collected prior to the shutdown.
"Only ‘life-and-death’ work is expected to persist, although the DHHS has noted that the FDA will attempt to continue limited activities related to user fee-funded programs, such as medical device approvals," according to medtech analyst Robert Littlefield of GlobalData. "GlobalData expects the shutdown to appreciably limit agency panel discussions as well as result in the indefinite postponement of meetings, which could muddle commercial launches and spook device company investors."
It’s also likely that the FDA’s guidance-release efforts would be hampered, perhaps even halted entirely, until things get running again on Capitol Hill, Littlefield wrote.
Leave a Reply
You must be logged in to post a comment.