Is the Critical Path Initiative in Critical Condition? Is the Advancing Regulatory Science Initiative Replacing the Critical Path?

MedEmerg
Does anyone remember the FDA's Critical Path Initiative (CPI)?  Anyone?  Does the FDA even remember the CPI?  

The CPI was launched six years ago in 2004 as the "FDA's national strategy for transforming the way that FDA-regulated products are developed, evaluated, manufactured and used."  That is according to the home page for the CPI.  According to the last available annual report from 2008, the CPI "has become the main engine driving FDA's push to develop 21st century tools and methods for monitoring food, medicines and treatment approaches."  The entire effort was in response to a 2004 report that challenged the existing paradigm for drug research and approval put out by Health and Human Services called "Introduction or Stagnation:  Challenge and Opportunity on the Critical Path to New Medical Products" which served as a call to action.  

The CPI was the result.  As Dr. Janet Woodcock put it in a 2008 article on the CPI, "FDA's mission is to protect and promote the health of the public.  With respect to drugs, biological products, and medical devices, this translates into ensuring reasonable product safety while also facilitating the translation of scientific innovation into commercial products.  The ongoing tension between these two objectives results in assertions that FDA requirements are stifling innovation, and simultaneously that FDA standards are too low.  The thesis of the Critical Path Initiative is that scientific advances in the development process are the best way to resolve these conflicts to the satisfaction of most parties and to benefit the public."

How is it doing?  Since the CPI began, science is moving relentlessly forward.  Nanotechnology is being explored, the genome has been mapped and patients are awaiting a range of breakthroughs based on emerging research such as personalized medicine and even the possible creation of a new pancreas.   

Which leads to the question, what is CPI doing?  That would lead one to the Web site for information.  But if you click on the Past Events section of the home page, there are only 18 events listed.  There were none in 2004 and 2005 and only begin in 2006.  Most were workshops, a few Part 15 meetings and some testimony.  The most recent was January 11, 2010 and was entitled "2nd Annual Sentinel Initiative Workshop."  The next most recent event listed was in June, 2009.  

If you click on the "Upcoming Events on CPI", it gets a little more depressing.  There are three items listed.  The first says "FDA Awards Contract to Harvard Pilgrim to Develop Sentinel System Pilot" and when you click on it, you get "Page Not Found".  The second upcoming event is entitled "Structured Product Labeling Release Four Training Sessions".  When you click on it, there is a page that describes four training sessions, which are apparently Web conferences as well as face to face sessions to discuss aspects of the FDA's acceptance of electronic submissions, which occurred in June, 2009.  No dates, times or places are given for the sessions.  The final upcoming event is "CPI Funding Opportunities" which takes one to a document that is a Request for Applications.  Under the "Key Dates" section, September, 2009 is listed as the expiration date.  There are no other activities listed in the Upcoming Events. 

Is this the "main engine" driving FDA's approach to the 21st Century?  I don't know about you, but I don't feel very good about that.  If there is more to it than that, it is not being well communicated.

Which is the point.  The CPI may in fact be doing wonderful things from a science and research perspective.  I'm not a scientist.  But if that is the case, the communications around that effort are certainly lacking.

There have been signs for some time that the CPI was not getting the funding it needed and not performing as robustly as envisioned, as evidenced by a 2007 article in the Journal of the National Cancer Institute "FDA Starts Moving on Critical Path, but Initiative Running Out of Steam" that simultaneously outlines the promise for the initiative, but also the lack of funding and the initiative is reportedly funded this year at about $16 million.  

And yet, in the FY 2011 budget, there is a new initiative for which funding is sought.  It is called the Advancing Regulatory Science Initiative and the funding for it is $25 million.  What's the mission? According to the FDA, the effort "will allow FDA to strengthen its core scientific capacity.  This investment will allow FDA to identify improved pathways to product development and approval for new technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease." (emphasis added).  

Huh? Well, that certainly sounds familiar.  I thought CPI was advancing regulatory science.  How then is the CPI different from the Advancing Science Initiative?  And how will the latter differ from the former in terms of a robust approach to advancing science.  Do we need both?

The point is this – call it what you will, Critical Path or Advancing Science, an initiative that is not supported by a sound communications strategy is probably not bound for success, and certainly not be a winner in a competitive budget environment.  That has certainly been the case with the CPI, whatever its scientific success (0r lack there0f).  

Which leads back to the first question – Is the critical path in critical condition?    Do we need two initiatives aimed at the FDA's ability to regulate new products and advancements in science?  Do we need to begin a second one, when the first is underfunded to begin a second?  And if the CPI is moving us forward, shouldn't the CPI Web site be reflecting that activity and success?  

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