Compliance Gone Wild (OrthoSpineNews)
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 find themselves working to prove that they are NOT violating off-label marketing, anti-Kickback, of 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 myriad 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 business leaders risk peril when they challenge or overrule compliance suggestions o...
