Stability testing

John S. Haystead

During the last few weeks, I’ve spent a lot of time out of the office. That’s partly why this editorial is once again the last thing to be handed over to my increasingly restless managing editor. Even so, however, I have no doubt that it was time well spent.

During my travels, I had the chance to speak with, and hear directly from, a great many industry professionals–from many different organizations, job levels, areas of expertise, and geographic locations–about the current state of, and future prospects for, the health and vitality of the industry. And, what I came away with, almost universally, was the distinct impression that we’re in the midst of a “strong and building positive momentum.”

That’s the good news. The bad news is, I’m not able to describe it as an “enthusiastic Groundswell.” It’s closer to “cautious optimism.” That’s why I’m not at all surprised by the industry’s wary response to the recent announcement of FDA Commissioner McClellan’s imminent departure.

Clearly, many of the initiatives helping to generate the current industry momentum can be attributed to Dr. McClellan’s policies, or at least to an environment where new ideas and initiatives could be fostered and nurtured. And now, people justifiably want to know if this philosophy will continue.

So far, FDA says it will. And, that’s very good to hear. In fact, it’s the “hearing” that’s important, because the last thing the industry needs right now is for its hard-won momentum to be stalled over uncertainty.

Uncertainty will stymie not only innovation generated from within the pharmaceutical industry itself, but also discourage investment by other technology sectors (such as information technology) in pharmaceutical-centric product development–outside investment that will be critical to building the next-generation capabilities and systems the industry needs to rapidly advance.

As we move forward, I encourage FDA to continue to reinforce its “21st Century” message by all available means, such as through conferences, publications, directly to industry through its inspectors and inspection teams, and particularly through its working and advisory groups. Pharmaceutical professionals are well aware that it takes time to draft and fully define important policy initiatives and procedures, but, in the meantime, FDA can provide tremendous benefit by simply letting the industry know that the title of its “work-in-progress” is not being changed–and that the ship remains on a steady and stable course.

John S. Haystead, Editor in Chief

COPYRIGHT 2004 Advanstar Communications, Inc.

COPYRIGHT 2004 Gale Group

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