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Whatever Happened to the Critical Path?


By John Russell

April 12, 2007 | Is the Critical Path Initiative dead? OK, that’s a bit rhetorical (and heretical, as I certainly hope it’s not). But a year ago, with great fanfare, FDA trumpeted release of the CPI’s “Opportunities Report and List” which presented 76 specific scientific opportunities that, if undertaken, “would help modernize the Critical Path sciences.”

Since then, at least the media outreach around the Critical Path Initiative has been, well, non-existent.

I’ve always thought the Critical Path Initiative was a good idea and argued in this space for supporting it (Best of the Best, Sir, Bio-IT World, April 2004; Lobbying for Critical Path Funding, Bio-IT World, April 2006). Last summer I suggested to my boss that a larger multi-article report on the Critical Path Initiative progress would be a great read and a good idea. He agreed, the topic went briefly onto the editorial calendar, but the pervasive public silence around CPI project muted our own enthusiasm and the proposed special report became a good-to-do instead of critical-to-do project.

One fears the same has happened at FDA.

The Critical Path Initiative was first unveiled with great enthusiasm in March 2004 — Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products — by FDA commissioner Mark McClellan who was about to move from FDA to become CMS administrator. It’s not clear how much work he did framing the initiative, but McClellan certainly put his stamp of approval on it. The CPI staked out important objectives.

Here’s an excerpt from the report’s opening section: “In FDA’s view, the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences.... A new product development toolkit — containing powerful new scientific and technical methods such as animal or computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques — is urgently needed to improve predictability and efficiency along the critical path from laboratory concept to commercial product.”

Innovation? Stagnation?
Constructing such a toolkit is clearly not an overnight exercise,  and a variety of issues — lack of better funding, the FDA commissioner shuffle (McClellan, Lester Crawford, and now Andrew von Eschenbach), and shifting FDA priorities (internal reform spurred by Vioxx and other controversies) — have drained attention and momentum from the Critical Path.

(FYI, Crawford, whose scant two-month tenure as approved commissioner was cut short  by financial controversy, was recently sentenced to three years’ supervised probation and fines of roughly $90,000 for lying about stocks he owned in companies regulated by FDA. He also must conduct 50 hours of community service and pay for the costs of his supervised probation.)

It’s not that nothing has been done. FDA says 40 CPI opportunity projects are moving forward, and the agency spreads the word by regularly updating its ‘Critical Path Opportunities Initiated During 2006’ document online. Many are quite important, but some seem less ambitious and perhaps not representative of the paradigm-changing vision required to build the kind comprehensive toolkit as described above.

Maybe that’s unavoidable. Science progresses at its own rate and medical science is necessarily more cautious than other branches. But it feels like the lack of money and mindshare are turning the CPI into just another umbrella project. Without a committed voice of stature constantly rallying the project onward, the Critical Path Initiative has lost any sense of urgency.

Maybe that’s good. Maybe it’s not. Maybe it’s just a PR problem. Now seems like a good time for FDA to re-assert the CPI’s scope, even if doing so means sober reassessment for near-term goals. This project was begun with enormous fanfare. Letting it dwindle now would be a shame.

Write to me with your ideas about the Critical Path Initiative’s value and future at john_russell@bio-itworld.com.

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