Those who read this column should know what my guiding principles are. The way I express them may anger some friends, or win over some enemies. But, like everyone working in this industry today, I do care deeply about the quality of pharmaceuticals on the market. Collectively, we have vast knowledge of our processes.
Recently, though, I was asked a very simple and very timely question. Considering recent events, it was not much of a surprise, yet I had no idea how to respond, or whom to turn to for a reasonable explanation.
The question was, “Why has the number of pharmaceutical product recalls increased recently?”
How would you answer it?
Now, I refuse to believe that any pharmaceutical manufacturer would intentionally make adulterated or sub-quality product. I do not believe that any company’s quality system has been modified so drastically to cause this increase in product recalls. I don’t believe that manufacturing processes have changed, intentionally or even accidentally, or that manufacturing professionals have stopped following procedures on a grand scale.
FDA has not changed the way it operates. So what is different?
Visionaries from within the industry continue to warn us of what will happen if we do not change the way we approach drug development and manufacturing. What is preventing necessary change?
Pharma is suffering from acute homeostasis, which, in turn, has resulted in state of equilibrium, in which tension or the drive for change has been reduced or totally eliminated. The silo mentality that continues to exist within this industry is both a sign, and a driver, of this equilibrium, and has led to an almost adversarial relationship among key functions that need to work in concert: R&D, manufacturing and quality control.
Consider some of the change projects that your own companies may have initiated recently. They are all designed to foster change, but in reality, how many really aim to return the system to equilibrium? How many embrace true crossfunctionality, and open, universal access to information and resources?
If any of you have watched the classic Disney children’s film, The Lion King, you may recall the scene in which the wise baboon Rafiki raps the lion, Simba, on the head, noting that one can either run away, or learn, from the pain of the past.
What will pharma learn from this painful period of acute drug shortages, QC problems and product recalls? Will all this pain, cost and negative publicity be enough to bring about change?
Surely just wishing for a different system is not enough. Hard work is needed, both systematically and tactically, but it will require a unified effort, rather than a random set of projects or actions. What is required is nothing less than a fundamental change of culture from tribal and siloed, to open and universal.
Change agents will be needed, and they’ll require support from senior and middle management through the rank and file workforce. Alliances need to be forged, maintained and nourished through open and honest interaction and the development of a collective vision.
This culture must embrace diversity of thought. Different functions must recognize, as Deming did, that work processes cross the boundaries of multiple sub-systems.
Identifying the change that we desire is a vital necessity. Recognizing the forces resistant to this change, and those supporting it, is also vital.
Having achieved these goals, everything we do must aim to weaken negative forces and strengthen those that support change. There are those who may feel that the forces resisting change are too strong to overcome, whether they come from within their own organizations or from regulators. They subscribe to a static culture.
Change has already been documented in other industries, spurred by thinkers such as Deming and Juran. Such change is not beyond pharma’s reach.
Do you think that our industry is in desperate need of revitalization? Do you believe that you could be a change agent, or do you at least believe that change is possible?
Are you willing to take action within your organization, or even, simply to engage in a dialogue on this forum? If so, please write me at [email protected].