Ignorance is No Excuse

I have lived in Washington State for most of my life (with brief stints on the east coast, but that’s for another blog another day).  One of the unique aspects of living in the Pacific Northwest is our proximity to Canada. In my lifetime, I have made numerous trips across the border that sits just a few hours north of where I live.  Today, I am only a 90-minute drive to the Peace Arch crossing – less time than some people spend on their commute to work.  This proximity has led to a feeling of complacency when it comes to thinking of our northern neighbors as a Completely. Separate. Country.  We tend to think of Canada as another state with easy access, though a somewhat longer line at the border.  I was reminded recently that this is, in fact, very much not the case.

I have clients in Vancouver, British Columbia, just a 2-hour or so drive from my house.  But, to get there I must cross the Canadian border.  Having a passport card, I have expeditiously made my way up to visit these clients on a few occasions in the last few months. So, it was a complete surprise when I attempted to cross the border last week to attend a meeting, that I was asked to pull aside for further review.  Let me be very clear, it doesn’t matter that this was Canadian border patrol, our friendly neighbors to the north that pulled me over (isn’t Canada just another state next door?).  I was alarmed and very nervous, and sincerely baffled at what I had done wrong. I was questioned. They searched my car. They made me wait.  

When I was finally brought up to be told my fate, I found out the problem – I did not have a work permit.  What?  I work in the U.S.  Yes, they said, you do. But you are a consultant and your brain is your work, therefore you need a permit to meet with clients in Canada.  I had no idea, I said.  He said, “You should have known.”

He was right.  Ignorance of the requirement that I have a work permit to engage with clients in Canada was no excuse. I violated the law.  International law!!  He could have barred me from Canada for a year (a realistic and frightening enforcement action).  But because I was honest (always a good policy!) he simply turned me around and sent me home.  

What does this have to do with regulation of medical products in the U.S.?  The experience got me thinking about how ignorance is not an excuse, not just at international borders, but also in regulatory affairs.  I had become complacent about Canada being a different country and didn’t bother to consider whether I was compliant with its laws when visiting clients there. Similarly, medical product sponsors can become complacent about compliance with FDA regulation.  In some cases, I’ve encountered small companies that claimed to be completely unaware of FDA’s quality system requirements.  The lesson here is that ignorance of FDA’s regulations, particularly changes to those regulations, is not an excuse for non-compliance.  The burden of compliance is on manufacturers of medical products to understand FDA’s requirements and implement and maintain compliant quality systems and processes.  Given the number of quality system violations regulatory reported in Form 483 findings and Warning Letters, it seems a good time for a reminder of this expectation.

I am thankful to not be barred from Canada.  My work permit application is in process, and I hope to be freely crossing the U.S.-Canada border again soon.  If you are a medical product sponsor, may I suggest a check on those quality systems?  Even though our intentions may be good, ignorance of applicable regulatory requirements is no excuse to violate the law.

Need help with your quality system compliance? Contact me!