Sunday, July 31, 2011
“Quality, Cost and Speed—pick two.” This was a truism often quoted throughout my career.
Sacrifice Quality with low Cost and high Speed.
Sacrifice Cost with high Quality and high Speed.
Sacrifice Speed with high Quality and low Cost.
But does there always have to be a loser? Unfortunately, it seems to work out that way in practice.
A report dated July 27, 2011, came out from a special committee of J&J board members in response to investor lawsuits. It reported “an adversarial relationship” between quality and production; and “an emphasis on production volume” over compliance.
The committee concluded that the consumer division at J&J “should have paid more attention” to quality issues and “exercised more management oversight.”
But, here’s the real kick-in-the-pants.
This J&J blue-ribbon committee of their board was quick to take themselves off the hook by saying (I am paraphrasing):
· Nobody on the J&J Board told McNeil that quality should be sacrificed.
Nobody in his or her right mind ever gives a direct order to ignore quality. Pressure comes in much more subtle form in our industry today under the guise of “restructuring”, “Lean”, and “quick business acquisition integration” programs that are directed totally at cost reduction. These are company programs that line management is rewarded to deliver.
Someone needs to ask the J&J board of directors, “Which consulting firm gave that advice, and who at J&J approved the 35% corporate quality and compliance staff cuts in 2007?”
· Nobody told the J&J Board there was a problem.
Rarely is the person appreciated who tells the “emperor he’s naked.” They are characterized as troublemakers and non-team players. They are the ones who are obstacles to getting “drugs to our patients.” Fear of unemployment fosters a “don’t make waves” cultural environment that is endemic.
Here’s where the quality assurance function must rise to the occasion to make objective data become the indisputable target, not the messenger. That is—unless they also have drunk the Kool-Aid.
· The J&J board acted aggressively when they found out about the problem.
Isn’t this always the case? The Sarbanes-Oxley Act of 2002 was to have ushered in an era of corporate responsibility where company boards were to proactively and independently keep an eye on the legal and regulatory matters that affect the stockholders. Somewhere along the line the practice became limited to financial reporting—not compliance to CGMP.
However, all FDA Consent Decrees of Permanent injunction are accompanied by stockholder lawsuits. So you would think CGMP compliance would be on their fiduciary radar also.
So, what about Quality, Cost and Speed?
No doubt about it. These dimensions are truly interdependent.
However, great companies should be able to have honest and frank discussions about daily decisions along these three dimensions. There should be an advocate for each—quality, cost, speed—with an equal voice that is encouraged, respected, and rewarded. This is where balance is found.
Troubles begin when—for whatever reason—any one of these voices is stifled, or when any one of these voices becomes more powerful than the others.
The QA Pharm
Saturday, July 16, 2011
Responses to FD483’s and Warning Letters are usually fully of commitments. They involve “what” will be done to correct compliance problems, and “when” it will be done. FDA has even started to ask “how” they will be done, meaning—Do you have the resources to do the work?
If these questions are not fully addressed in the FD483, then FDA asks again in the subsequent Warning Letter in the part where they acknowledge receipt of the firm’s FD483 response—and the inadequacy of it.
It is very formulaic and very predictable.
So, my first point is that there is no excuse for an inadequate response to an FD483 or a Warning Letter.
There are plenty of Warning Letters on the FDA website that provide examples of poor responses and what the FDA thinks about them. There’s no excuse for not knowing how to respond. (Also see The QA Pharm, October 10, 2010.)
Reasons for poor responses are:
· Arrogance (What problem? Let me explain why we have no problem.)
· Bad advice from house counsel (Dance around the edges, but never admit having a problem.)
· Minimalism (Commit as little as possible and don’t look for other problems.)
· Being far removed from the problem (Responses are so bad that it makes your technical insiders embarrassed.)
· No root cause (Doing lots of stuff, but very little directed toward the real problem.)
· Poor writing skills. (Difficult to follow the story line, because you have no idea what you want to say.)
My second point is never, ever miss a commitment date.
If anyone were to ask the leadership of any company under FDA enforcement action whether FDA commitments should be taken seriously, the response would be a resounding “Of course.”
Yet actions say differently.
It continues to amaze me how many companies miss commitment dates. And even more amazing—the senior management had no clue they had missed them. This is totally unconscionable and an indicator why the company has compliance trouble in the first place.
Reasons for missing commitment dates are:
· No system to track responses and commitments
· Responses and commitments are buried with hundreds of other TrackWise records, most of which are also overdue
· Overly project managed until there is more planning than action
· Lack of visibility as a standing agenda item in the management boardroom
· No accountability at any level for results
· Agency responses are kept a secret, or not sufficiently distributed to employees
· Those responsible for doing the work had no idea that a commitment was made
The best way to think about the seriousness of a commitment to the FDA is to remember that the FDA already suspects a noncompliant firm to be untrustworthy—or at best they are neutral about their credibility. To not deliver on a commitment date just confirms their suspicion and puts the relationship between the firm and FDA on shaky ground.
Not providing an adequate response simply indicates being out of the mainstream of pharmaceutical industry know-how. And missing commitment
dates is nothing less that breaking a promise.
How would you feel if you were not taken seriously?
The QA Pharm
Sunday, July 3, 2011
The answer depends on who you listen to: the FDA or the EVP at CSL Biotherapies.
According to the FDA Warning Letter issued on June 15, 2011, the issues are among the most significant as any we have seen in recent years following the company withdrawal of the vaccine after reports of seizures with use in children.
Any observer and student of FDA enforcement recognizes the serious combination of observations:
- No documentation of adverse events
- Lack of production and process controls
- Inadequate investigations into batch or component failures
- Failure to reject components that did not meet specifications
- Inappropriate laboratory methods
The list is lengthy. The list is significant. The list is serious.
And the Warning Letter is topped off with the universal conclusion that we have seen with McNeil, BMS, Ningbo Smart and others reported in this blog—“Your Quality Unit is not fulfilling its responsibilities.”
When the FDA doubts the Quality Unit—it doubts everything.
So what about the flu supply from one of the world’s largest flu vaccine manufacturers? Are they too big to fail? Will they be permitted to supply the U.S.?
Don’t count on it.
Remember the 2003 production problems at Chiron’s Liverpool flu vaccine manufacturing plant? Remember the shortage? Remember the politics and congressional hearings?
So what’s different this time? Let’s hope a lot.
For starters, the Warning Letter was issued within a record two and a half months of the inspection. Also, the FDA requested a meeting with the CEO and other senior management, which is the equivalent of saying, “We’re in this mess together.”
So, how does the EVP at CSL view their issues?
Mr. Jeff Davies, CSL’s EVP was interviewed on “PM with Mark Colvin” on June 22, 2011.
Mark Colvin asked Mr. Davies why he thought that CSL failed to satisfy the FDA. Mr. Davies replied, “I think they’re just concerned how we documented that process.”
It’s going to be a very interesting meeting with the FDA if CSL’s going in position is that it’s all a matter of paperwork.
Let’s hope for the global flu vaccine supply that it isn’t.
The QA Pharm