While Federal Investigators have the Brinks trucks lined up delivering penalty revenues in the billions, today’s pharmaceutical and medical device companies are forced to take extreme actions to safeguard themselves from scrutiny. No longer is it enough to do things in a compliant manner, in this environment companies carry the burden of proving that they are NOT violating off-label marketing, anti-Kickback, or FCPA guidelines. Proving a negative is almost impossible, so in efforts to thwart personnel from violating these laws, companies are implementing and empowering Compliance teams like never before.
With the impossible task of proving the negative squarely on their shoulders, Compliance leaders are forced to do the next best thing, which is prove that everything has been done to prevent the negative. This takes the form of instituting a myriad of policies to document SOPs, extensive training, oversight, and disciplinary actions. With so much at stake (think hungry Brinks trucks standing by) Compliance teams naturally implement every conceivable measure and the corporate business leaders risk peril when they challenge or overrule compliance suggestions or directives.
In many companies the compliance team is not familiar with how products get designed, built, sold, shipped, etc. Instead, their knowledge is based on what must be avoided. Since ensuring that employees are NOT doing things is far more challenging than the opposite, teams must look harder at everything, and implement check points, inspections, or oversight into every process. While important, these mean extra work, more time, and delays to the business at hand.
Remember those drivers-ed training cars equipped with a brake pedal for the passenger seat? We now have Compliance teams perpetually riding shotgun with foot poised above this proverbial brake. They are checking our speed against the posted limit, asking not where we are going but why, and requesting documentation that the chosen route is best, safest, and shortest. So will this ever change?
This can change, yes. However until every driver effortlessly follows the rules of the road, that brake pedal will stay there, right at the feet of the Compliance team. Once compliant practices are fully understood and accepted by all personnel, and the new processes become as second nature as those required to requested a check or approve an expense report, two things will happen. First, Compliance will naturally revert to intermittent checks instead of system-wide involvement. Also, as more people in the organization understand the rules as well as the Compliance team, business leaders will be equipped to push back on excessively restrictive Compliance decisions. Remember that Compliance is tasked with proving the negative, so it’s natural to build in a margin of safety which often translates into potentially unnecessary hurdles to accomplishing key objectives. Leaders who understand the laws and guidelines can differentiate between the absolute requirements and this safety margin, and will be empowered to push back.
I remember in drivers-ed there was an odd intersection where I had the right of way, yet I would always slow down anyway. The driving instructor would slide his foot behind his brake pedal and pull back to prevent me from braking at all. It never occurred to me that I might be able to put my foot behind the brake pedal on my side and do this back to him later on down the road….