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by Mark S. Senak
Eye On FDA



Yesterday the FDA issued a news release that was entitled the "Critical Path Opportunities for Generic Drugs" that raises more than a few interesting points.

First, it has been a long time since we've heard much about the FDA's Critical Path Initiative. So long, in fact, I would venture to say that most people could not tell you what the Critical Path Initiative (CPI) even is about. The generics report referenced above opens with the sentence "FDA’s recent critical path initiative has focused on the challenges involved in the development of new innovator drugs, devices, and biologics" for those of you who may have forgotten what the initiative is about. Emphasis on the word recent is my own.

I don't know about your definition of "recent" but on the FDA's Critical Path Web page, there are documents going back to early 2004. That is like referring to my recent birthday of three years ago.

Second, the CPI is the kind of thing that, if presented well, could serve to help rehab the agency's suffering image. But when an entity begins an initiative like the Critical Path, it is essential to define it in the minds of your audience and then provide milestones to review progress, which the FDA has done from time to time, but which tend to read like a checklist rather than a statement about the goal of the initiative and how progress has been made. The reports, also, are not of value to make the thing real for people if people don't know what the initiative really is in the first place. To that end, you would want to cultivate outside third parties - as well as create experts in the media on the critical path and to devise key methods for keeping it in the news. You would have the program engage with other partners who can also keep the initiative top of mind.

Ironically, the logo for the CPI is

Unfortunately, it would appear that efforts to promote the initiative fall below the line, not above it. Promotion has to expand beyond an occasional press release, it needs to become part of the culture. That is a process, not an event.


Source: EyeOnFDA.com

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