From the Editor: Is the “Desired State” Really Desired?

Research suggests that a dysfunctional relationship between regulator and regulated is delaying pharma’s progress.

By Agnes Shanley, Editor in Chief

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Every day, in the U.S., we are inundated with the lingo of pop psychology, and stories of 12-step programs, interventions and therapies. This national obsession has become a joke to the rest of the world, and, on an individual level, we may be sick and tired of it all.

At the same time, however, there is something to it. One of psychology’s biggest recent breakthroughs has been reaching an understanding of how addiction and other negative behavior patterns affect relationships, and how these patterns are perpetuated and transferred.

Those within “dysfunctional” situations deny that any problems exist. In the worst cases, they may show passive aggression and send mixed messages, and even sabotage one another.

Unless conditions are recognized and changed, over time it becomes increasingly difficult for them to work together, to do anything positive. Psychologists estimate that at least 20% of the U.S. population lives under these crippling conditions at home.

But, one wonders, can similarly destructive patterns play out on a much larger stage, within companies and within industries? Does the secretive and siloed nature of the pharmaceutical industry, and many regulatory agencies, perpetuate negative practices?

Have decades of negative interactions between FDA and industry created “grooves” upon which both regulator and regulated move, but which don’t lead them any closer to professed mutual goals?

I wondered this as I read a December 2009 report by a major consulting company, which had been commissioned to analyze one of the world’s leading regulatory agencies, and the progress of Quality by Design (QbD), the subject of this month’s cover story ("Can You See the Real QbD?") and one key initiative on pharma’s road to the “desired state,” as articulated by ICH. 

You probably already recognize the report, and much of the information within it has already been circulated and reported on at length.  
Some of it hasn’t, though, and may surprise you. (For a copy of the report, which I received from an anonymous source with no ties to either the regulatory office or the consulting group involved, or our magazine, please visit PharmaQbD.com). 

Within companies, the consultant found, there is lack of cross-functional alignment, both intramural and intermural, lack of belief in the business case, insufficient data management, and lack of standardized systems. QbD is often viewed as benefiting manufacturing and operations, but as being paid for by R&D. As a result, in highly siloed companies, efforts can be torpedoed.

Within the regulatory agency that the consultant studied, the report found inconsistencies in the level of support for the initiative, lack of tangible guidance for industry, lack of sufficient knowledge and preparation, and interactions that failed to inspire confidence and trust. “We are treated with suspicion,” said one industry professional interviewed by the consultants.

The result is the same type of standoff that often blocks positive communication within families and relationships. One interviewee perhaps put it best, “Today the best CMC strategy is to not show all your cards.”

Others complained heatedly of the way regulatory benefits have been promised. “We started this because we were promised regulatory benefits, now we can’t even talk about them. It’s like [the regulator] has amnesia.”

The consultant asks that such incentives as a faster review process, or more flexible change processes, be considered, and proposes that a Quality by Design approach might even be mandated, in some cases, for generic pharmaceuticals—particularly the more complex controlled and modified release drugs. Today, the consulting company says, too many generics manufacturers are operating with a focus exclusively on being the “first to file,” which can lead to safety and quality compromises.

The consultant also suggests that the regulatory agency adopt standard ways of reviewing QbD applications across all divisions and offices, with one clear, broad definition set that can be standardized based on whether the drug is generic, name-brand small molecule, or biologic.

The regulatory agency paid the consulting group to analyze these issues. Whether they might have found a less expensive “shrink” is beside the point. They have recognized the fact that a problem exists and thus taken the first step to recovery.

This year we’ve seen some positive developments—for instance, the alignment of U.S. and European regulatory agencies in QbD review and even the dissemination of more information from actual case studies.

Of all the findings in the study, perhaps the most interesting were the fact that QbD, correctly implemented, adds only minimally to cost and drug development time, shattering two major myths.

Perhaps both regulator and regulated need to forget their past history and simply analyze quality as it is handled in other industries, as this month’s cover story suggests.  Otherwise, they’ll continue to see only part of the picture, and to travel along the same unproductive grooves.

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