When a pharma CEO said “We'll be adding 250 new people to our Quality Assurance and Control organisation to address concerns identified by the FDA” he was 'bandaging Snowden's leg' – a syndrome (described in Heller' “Catch 22”) in which zealous attention is focused on a peripheral problem while life leaks away from an un-noticed, central trauma. In the book, Snowden dies. And the prognosis is not much better for a corporation which makes compliance its objective instead of getting down to the real needs of the business.

 

Make no mistake, compliance matters.  Regulators enjoy rising public confidence, much of it fuelled by well publicised pharma failures.  If you don't hit the mark, the consequences can be swift and severe.  In the USA, the FDA can come in and take control.  They'll make you comply, but what about a lasting solution to the problems?

 

If desperately chasing compliance is not the answer, then how do you stay compliant and raise business performance?  Perhaps the place to start is by answering the question 'Why aren't we compliant anyway?'