From the Editor: Just Where Does the Buck Stop?

If senior management is held directly accountable for cGMP problems, could we see a very different approach to manufacturing?

By Agnes Shanley, Editor in Chief

As most students of U.S. history know, the late President Harry Truman had a sign on his desk, one side of which read “The buck stops here.”* (The other side reportedly said, “I’m from Missouri, show me,” no less relevant to pharma, but I digress).

With this statement, said to have been coined by an Oklahoma prison warden, the CEO of the U.S. government assumed accountability for anything and everything that happened during his watch. 

At drug companies today, CEO’s are held accountable for many things. Stock price down? Shareholders angry? Take it to the CEO. Clinical trial results or marketing practices ethically challenged? The CEO has your ear.

But how many pharmaceutical company CEO’s know, or care, about cGMP’s or manufacturing? For many of them, manufacturing is still a “black box”: “I don’t care who does it, just get it done, however and wherever and at lowest cost.”

It has surprised me, seven years after joining this magazine, to see that manufacturing—a lynchpin to better R&D, supply chain management, drug quality and even drug discovery—continues to be the industry’s stepchild. Those leading the move to change and improve manufacturing either lose interest or are downsized in cuts that look at overall capacity utilization rather than team contributions to cultural change and improvement.

My own vested interests and emotional attachment to the topic aside, is that approach sustainable? Do managers in any other industry treat manufacturing and its expert practitioners so lightly?

The Park Doctrine, and FDA’s push for accountability, may yet drive a top management focus on quality.

Our survey on process control and automation suggests that little has changed in the way industry approaches manufacturing. Many companies reject more modern approaches such as process analytical technologies and Quality by Design, as well as tools as fundamental as statistical process control (SPC), which, if it’s being used at all, is being applied in a univariate way to a complex and multivariate world. As consultant Ken Leiper puts it, “It’s not Deming, it’s damning.”

Years after the Wall Street Journal’s two-story blender article and former FDA commish McClellan’s “soap flakes and potato chips” quote, after the zealous articulation of “The Desired State,” after studies revealing that manufacturing wastes over $50 billion per year, every year, and capacity utilization remains at 30%, how far have we come?

Not very far. Because if we had, there would be far greater attention, from the top level, to manufacturing, and cGMP’s. 

At most, if not all, pharma companies today, these are seen as someone else’s problem.  But whose? The head of Quality’s? The chief compliance officer’s? The chief risk officer’s? The head of regulatory affairs’? 

It’s only when the 483 or consent decree come, or when the media calls, that we see decisive actions taken. “Off with their heads! Fire those incompetents!” But who set up the system that rewarded them for working as they did, or ignored its evolution?

The mainstream media is picking up on pharma’s management disconnect in a way that makes the WSJ’s seminal article seem almost irrelevant. After receiving one call from a newswire reporter in July, I heard from an associate producer of the “60 Minutes” TV show, aptly named Hornblower, who was planning a story on drug manufacturing issues.

Yes, folks. Not the glamorous world of sales and marketing, discovery or R&D, or the colorful world of global counterfeit intrigue, but boring old, standard issue manufacturing and quality issues concerning the raw materials, active ingredients and finished drugs that are being sold to the public. 

Whether or not that program materializes, it is clear that people want to know. Are their drugs safe? Why all the recalls?

If you do not know where the cGMP buck stops at your company, you may be about to find out, the hard way, from FDA.

The Park Doctrine makes managers accountable for manufacturing violations even if they’re kept in the dark about them, but have the authority to prevent or correct them.

In August, reporters cited a letter from FDA Commissioner Hamburg to Senator Charles Grassley, mentioning the possibility of prosecuting pharmaceutical executives, using misdemeanors to hold them accountable. 

This was not in that letter, but felonies could also be possible, in cases involving data integrity, and situations where that integrity were in question and patients died. 

So, ask not where the buck stops for GMP’s, and for smart manufacturing and drug development. It stops with you, and ultimately, with your CEO.

*“Buck” refers not to the almighty dollar, but the “markers” used in poker, which used to be knives made from buck antlers.

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