It's not unusual for me to hear from a colleague or client out of the blue. It's not even unusual that they're calling with "one quick question" they want me to answer "off the top of my head". I was prepared for something routine when I picked up an old friend's message yesterday. I was suprised, however, when what they really wanted to know was this: Does FDA actually put IVD executives in jail?
Oh boy.
My former client (let's call him/her "Sam") wasn't worried about going to jail personally. Sam actually had almost the opposite problem. Sam felt that fear of jail was driving his/her employer to persue needlessly conservative policies and engage in counterproductive over-analysis. Sam wasn't looking to skirt the law, but wanted to know if the threat of jail was truly as large a risk as his/her employer seems to believe it is.
I don't know how many professional education events I've attended where the speaker invokes images of federal marshalls busting down the front door in order to make the point that legal compliance is strongly recommended. Granted, compliance is very important. It's also well worth making the point that there can be serious consequences to flaunting federal law, including jail time. But do we really need every IVD CEO picturing themselves in an orange jumpsuit just to make this rather obvious point?
I don't think so. As lucrative as the medical device business can be, it's nowhere near easy enough to be of much interest to the criminally inclined. People who are truly willing to break federal laws to turn a buck can choose from any number of dodgy pursuits where the manufacturing issues are far simpler and the up-front costs are far lower.
Truth be told, there's not a lot of doors being kicked in or jail time being handed down to IVD executives of established companies. I've been in this business about 15 years and I've yet to work anywhere that got tear-gassed.
The enforcement actions (PDF) FDA highlights in its annual reports suggest that enforcement is focused on truly fraudulent and dangerous acts. If you're not dumping hormones into vats of milk or mixing veternary drugs with human drugs or committing other acts of flagrant adulteration, it's unlikely that an orange jumpsuit is in your future.
Although lack of compliance presents obvious risks, there is also risk to over doing it. Although process is important it is equally critical to bring new technology and ideas to market. No matter how carefully development is performed, some hazards will remain. These risks need to be weighed carefully against the benefit of new diagnostics becoming available.
Tags: Enforcement, FDA, Policy
