Giving all due respect to the many ways one can interpret Barack Obama's election on Tuesday, I can't help but wonder a bit how he may change the playing field in FDA-regulated industries.
Regulatory professionals don't typically like to offer opinions about unknowables like future events. Then again, there is every reason to expect that some profound changes may take place over the next few years. Failure to speculate at some level is an unwillingness to begin making plans.
So... with the caveat that my crystal ball is perhaps no better than anyone else's, I hope you'll indulge me in a bit of wild-eyed speculation. I can't stress enough that what follows here is conjecture, opinion, and supposition. It should be taken with the largest grain of salt you can find.
It seems sensible to assume that the low-hanging fruit will be the first picked. The FDA of the last six or eight years has, at times, seemed strangely unmotivated to enforce some clear violations of rules. In a little-publicized policy change in November 2001, all warning and untitled letters were required to undergo review by the Office of the General Council. This was heralded as a measure to ensure consistency, but it wasn't difficult to construe the change as an effort to slow enforcement.
Whatever the actual intentions were, the perception that it had the effect of curbing enforcement quickly took hold. There were published accounts in 2002 estimating that the turnaround time on letters ran as long as 210 days. The total number of letters released has dropped off for several years running and some observers have interpreted these changes as an enforcement shift.
Some companies have become convinced that skirting the law is now a lower-risk affair than it used to be. These last few years, they may have been right. I'm going to go out on a bit of a limb here, but the arrival of a more regulation-friendly administration may change the risks of non-compliance significantly.
I would be very surprised if the incoming administration doesn't make a point of enforcing existing laws more dilligently. It may already be happening as we pass into a lame duck administration. I've heard whispers that a shift toward stricter enforcement explains FDA's actions with LabCorp.
At MyRAQA, we make a point of steering our clients to stay on the right side of the law. Holding to the higher standard is good business and good citizenship. Regulated products tend to stay on the market for more than just one or two administrations, so a compliance-based strategy is the best long-term bet. But it's safe to say that not everyone makes that choice. Some companies decide to place a bet on the non-enforcement of a regulatory gray area. That play might prove a lot more risky in the foreseeable future.
Here's the bottom line: companies whose business model depends on non-enforcement or broad interpretations of existing law should consider themselves put on notice.
I have already received phone calls from people who want to know what an Obama administration means for them and I'll share the first piece of advice they get for free: give some serious thought to re-assessing the risks of non-compliance. Companies and executives whose only experience with FDA has been the FDA of the last six or eight years may be in for a surprise.
Next week, I'll dig a bit deeper and speculate as to what Obama's pharmacogenomics bill augers for the structure of FDA.
Tags: Enforcement, FDA, Obama Administration, Policy
