Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put it mildly, concerning label enforcement.
With that slightly weasel-like caveat, it’s worth noting three events in 2013 that will almost certainly impact 2014:
1) CDRH’s Office of Compliance Reorganization: With the addition of a Division of International Compliance Operations, watch for the FDA to shift focus and some budget funds to increased inspection and audits of foreign device manufacturers, and increased crackdowns on promotional claims (see below). Steve Silverman, Office of Compliance Director, is making the public relations rounds of late with events at trade shows and the like. He’s stressing that the new “look” OC will better harmonize and broaden enforcement efforts. We’ll keep an eye on this and report back.
2) Device Off Label Enforcement: If the old expression “the past is prologue” holds true, device makers would be well advised to take a good hard look at any public claims they, or a surrogate such as a doctor at a trade show, make about the wonderful things its gizmo can or will do for patients. Between May 1, 2012, and April 30, 2013, CDRH averaged two letters per month hitting medical device makers for making claims outside their 510(l) clearance and making claims requiring additional data they didn’t provide, among other issues. Early anecdotal evidence suggests this trend of more focus and more warning letters will continue to climb in 2014. Again, we’ll keep an eye out.
3) UDI Finally: FDA issued the long-awaited Unique Device Identification (UDI) Final Rule in September concerning label enforcement. Its driving force and 27 year FDA veteran Jay Crowley, has since left the agency for a consulting gig. It remains to been seen what impact, if any, his departure will have on an issue that’s vexed industry and the agency for many moons. I can’t think Crowley leaving is any kind of net plus in terms of helping to fine-tune the rule. Time will tell. Then we’ll tell you.
I didn’t even factor in the possibility of more budget shenanigans in Washington, D.C. I’m a naive romantic, and I’m not going to go there until I have to.
Happy new year!
