Oftentimes pharma has a split personality. One personality loathes firefighting, and the other needs a burning platform to justify doing anything that requires spending money.

Go figure.

This becomes evident in our industry when some companies can’t part with a pittance of their billion-dollar profits to establish or ensure that an effective and sustainable quality management system (QMS) is in place—along with suitable facilities and sufficient staff levels. It’s really obvious when they’re at the heart of a devastating drug shortage problem.

The burning platform appears in the form of regulatory enforcement actions, disgorgement and penalty fines, consumer stakeholder lawsuits, loss of goodwill from patient advocate groups, and a drop in stock price. A burning platform you want? A burning platform you get.

But what about the patient?

The patient deserves better. No company can claim to put the patient first without confidently knowing that a QMS is in place, it’s effective, and providing the data-driven evidence that you are operating in a state of control.

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