Compliance vs. Integrity: When What Feels “Right” is Wrong

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Post By: Catherine (Cate) St. John, VP, FDA Regulatory and Compliance Counsel, Kadmon Corporation, LLC

As someone who has responsibility for compliance at a small company in a heavily regulated industry, I’m acutely aware of the bad reputation that comes along with “compliance.” “Compliance” is not popular. No one brags about how compliant they are.  Compliancy doesn’t get anyone promoted. No one ever got a date by bragging about their score on a compliance training quiz. To be “compliant” is boring, just a necessary check on the list. Or, sometimes, employees perceive compliance as a scary minefield that can trap an innocent, well-intentioned employee through its byzantine rules.

So where does that leave someone with “compliance” in their title? No one is excited about compliance, but if we get it wrong there are dire consequences. For a small pharmaceutical company, that could mean the cost and expense of protracted investigations or litigation, heavy fines and/or lots of bad PR. In extreme cases, it also means jail time. The company protects itself by checking off the seven pillars from the U.S. Sentencing Guidelines, but I’ve always considered this a floor, not a ceiling. (In other words, it would be hard to have a compliant company without the seven pillars of compliance, but having the pillars doesn’t in any way guarantee that you have an ethical culture). While we attempt to reinforce compliance wherever we can, how can we ensure that our employees are compliant when no one is looking?

In order to address this dilemma, compliance needs some re-branding. Instead of focusing on having a “compliant” organization, we must begin to couch traditional compliance topics instead in terms of personal integrity – so the “culture of compliance” becomes a “culture of integrity”. If “compliance” can be re-framed as “integrity”, a change in nomenclature could result in actual real change in perception and acceptance. “Compliance” is something that’s forced on you, a boring training.  Integrity is essential to your personal reputation and sense of self. Integrity dictates what you do when no one is looking.

The trick here is that, at least in the pharmaceutical industry, there are some “compliance” issues that may not be intuitive, and there can even be disconnect between what is compliant and what appears consistent with personal ethics and integrity. For instance, it is illegal for a pharmaceutical company to promote its drugs for uses that it does not have FDA approval for – referred to as “off label” promotion. However, many doctors, particularly in oncology, use drugs as they see clinically appropriate, regardless of the FDA’s indication of approved use.

Imagine a sales representative meeting with an oncologist. The oncologist describes a patient dying of colon cancer. The oncologist has used all of the standard of care treatments to no avail. The sales representative knows that there is data on Drug X for colon cancer, but it is currently only FDA approved for pancreatic cancers. The sales representative may consider it her ethical duty, an act of integrity, to tell this doctor that Drug X could help this dying patient. This “act of integrity” is also illegal.

My job is to educate our employees so that they understand where their intuition on what is right or wrong might lead them astray in terms of compliance with the law, and to reframe what integrity is in this situation. I’ve also found it helpful to explain why the rules are what they are. For instance, in the example above, I would explain that the FDA goes through an involved process to determine whether a drug is safe and effective for a specific purpose. While we may have some preliminary data that indicates it will work in colon cancer, it has not yet undergone the vetting process necessary to determine it will work and will not cause some unknown side effects. While doctors are legally authorized to make these clinical determinations for their patients, that is based on their training and their assessment of the benefit and risk profile of a particular patient. As a pharmaceutical company, we do not have the tools to make this type of assessment, and we will always have an inherent conflict of interest because a sale of the drug, whether on or off label, results in profit for the company. In that way, I hope to integrate what is “compliant” into our employee’s personal integrity, so that it is not forced on them from above but coming from within.

1 COMMENT

  1. Good point being made. Healthcare, in particular, is heavily regulated. Of all the government settlements with healthcare entities, it is highly likely not all were nefarious actors, but some probably thought they were doing the right thing for patient care or the for the good of the staff (or other what seemed to be reasonable reasons), but ran afoul of regulatory requirements nonetheless. Thanks for this piece!

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