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Black, White, Shades of Gray

Civil and criminal investigations are becoming a more prominent feature in the world of FDA-regulated industries. People who never gave any thought to this….suddenly find themselves needing to understand how investigations work.

Being FDA-regulated means “always worrying that you will have to say you’re sorry.” But it matters whether you are apologizing to FDA or trying to apologize to investigators.

If you did something that the agency considers “wrong,” then the best response is to admit it forthrightly and act quickly to undo your mistake. FDA program staff or inspection/enforcement staffs are more likely to work with you to resolve the situation if they feel you have been cooperative, honest and contrite.

While a good approach for most situations, it may not suffice if you are under investigation by FDA’s Office of Criminal Investigations, the HHS Inspector General, the Department of Justice, US Attorneys, State Attorneys General or any of several committees of Congress.

Investigators have a different way of thinking, something I learned while a Senate staffer in the early 1980’s.

In general, investigative staff saw the world in black and white. There were good guys and bad guys.

The investigators’ objective was to expose wrong-doers and make sure they never had the opportunity to do wrong again. It rarely occurred to the investigators that intent, extraneous events or misunderstandings might provide reasons to temper their judgments. Dealing with such nuances was not part of their job nor did they try to understand the wrong-doer or why the problem occurred.

As a legislative staffer, my world was painted in shades of gray. No good guys, no bad guys….just other legislative staffers with whom I needed to work in order to achieve my chairman’s legislative objectives. I could not have done my job if I held absolute views about people or policy. I was in the business of nuances.

I suspect that most individuals in FDA-regulated industries are like me. The constant search for bad guys is not part of their jobs or temperament. They have no special insight or experience in dealing with investigators who view the world in such sharp contrasts of good and bad.

It is never a positive experience to be sitting across the table from an investigator. All options are likely to be bad ones, including public humiliation, civil liability and criminal prosecution. Exoneration is a remote possibility, even if you fervently believe you have done nothing wrong.

An FDA-regulated company can limit their exposure to such situations. This requires systems that review and monitor company actions at a very granular level. It requires a level of transparency that makes most companies nervous. It requires prompt action to dismiss any employees who violate company rules and any supervisors who looked the other way. No exceptions can be made, even if it includes someone from the executive suites.

Companies that follow this path are less likely to become the target of an investigation. A company under investigation that can document strict programs–prospectively initiated and rigorously enforced—will usually do much better than one promising “never to do it again.” A pre-existing company commitment to tough enforcement may be the only way to get an investigator to consider your alleged wrongdoing in shades of gray, rather than black and white.


My earlier columns related to this topic are:

The Beatings Will Continue… November 1st, 2009

….until the biopharmaceutical and medical device industries clean up their act.Read the rest of this entry »

Off-Label Promotion and Whistleblowing September 9th, 2009

Whistleblowing and off-label promotion of drugs and devices have become hot topics because of the September 2 Pfizer settlement with the federal government. While none of my views are specific to Pfizer, the company’s settlement provides an opportunity to comment on off-label promotion….and to encourage bio-pharma and medical device companies to engage in deeper soul-searching. Read the rest of this entry »

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