The Critical Path Initiative: A Good Idea at a Bad Time?

August 1, 2005

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2005, Volume 0, Issue 0

FDA's Critical Path Initiative is an excellent idea, but is the time right?

FDA's Critical Path Initiative is an excellent idea, but is the time right? The Critical Path Initiative has at its core the objective of modernizing techniques for drug development, not discovery, resulting in a streamlined pathway to the marketplace for new drugs. Some would say the time is always right for good ideas that intend to bring relief to patients who are suffering. I would generally agree with this premise, but for the Critical Path Initiative to succeed, FDA would need to cooperate with industry and academia in ways not heretofore seen.

Brian D. Bollwage, JD

The present political atmosphere

Janet Woodcock has stated the need "To embark on an aggressive, collaborative research effort to create a new generation of performance standards and predictive tools," with the hoped-for result being faster access to new life-saving and health-promoting products. Can this be accomplished in the present political atmosphere? Will the necessary collaboration between government, research and industry be able to achieve the innovations needed to bring new products to the public in a more effective and less costly manner? Have recent safety-based drug withdrawals and the attendant Congressional oversight and public scrutiny hamstrung the FDA's ability to innovate and take aggressive action? Has recent politicization affected the Agency's ability to make decisions based on scientific and medical concerns, or has political pressure impacted on the drug approval process? Has the failure to appoint a permanent Commissioner weakened the Agency's sense of direction and its ability to accomplish its mission? The mere existence of these and other questions suggest that there are fairly significant obstacles, which need to be overcome in order to give the Critical Path Initiative its best chance to succeed.

Innovation and constructive criticism

Under the best of circumstances, the Critical Path Initiative would require scientific and regulatory creativity and risk-taking to redesign the drug development paradigm in a meaningful way. As an FDA watcher for more than 25 years, I do not recall a time when FDA seemed to be under attack from so many different directions. Recent criticisms of FDA's performance in the area of safety-based drug withdrawal and labeling changes have never seemed so pronounced. Even FDA's proposed improvements for monitoring safety of drugs have come under attack.

Supporting innovation

Whether real or imagined, diverse political scrutiny and pressure (for example that associated with the review and approval of the morning after pill) must have a stifling effect on the Agency's ability and willingness to take aggressive action. Innovation is often born from turmoil, so some would argue that the time is ripe for the Initiative, but to succeed, innovation must be supported and brought forth in an atmosphere of constructive criticism. The Agency clearly does not enjoy this type of atmosphere today. But what can be done? Should the Agency lay back and wait for a more placid political atmosphere to pursue change, or should the Agency forge ahead with its plans to revamp drug development processes and tools?

Sharing a solution

In my view, no time is better to suggest solutions than the present. Will FDA be criticized from one corner or another for every action or proposal to change? Yes, they will. But these critics need to be brought into the process and made part of the solution rather than permitted to exist as gadflies that merely wax critical for political or other advantage. FDA has a history of success unmatched by any other health products agency in the world. Their attempt to create a new tomorrow should be applauded and supported.

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