Reasons for the Critical Path Institute

 

Citing the need for applied research that bridges the gap between basic scientific research and the product development process, the Food and Drug Administration (FDA) created The Critical Path Initiative.

A wake-up call: In a 2004 white paper now known as the Critical Path Initiative, the FDA called attention to an alarming decline in the number of innovative medical products being submitted for FDA approval.1 Reproduced from this report, Figure 1 shows that over a ten-year period of time investment in NIH research and pharmaceutical research and development increased by 250%. Yet, as shown in Figure 2, over this same period the number of innovative new products submitted for FDA review steadily declined.

10Years

Thus, fewer applications led to fewer product approvals. In fact, only 16 new medications received FDA approval last year, the lowest number in over two decades.2
Moreover, this comes at a time when the FDA's review time is shorter than ever before. In contrast to the situation in the 1980's, when FDA review times were long and averaged 40 months, today's decline in industry productivity is not due to sluggish regulation but due to a fundamental decline in new applications.
To partially explain this decline, the critical path white paper cited increasing failure rates and outmoded methods to test product efficacy during development - "often, developers are forced to use the tools of the last century to evaluate this century's advances." The FDA white paper concluded with an urgent call to action for collaborations between the regulators, industry and academia to improve the methods and processes employed in medical product development.

  • A Call to Action: To bridge the gap between basic scientific research and the medical product development, the FDA created The Critical Path Initiative with a goal to develop improved testing methods and processes to evaluate the safety and effectiveness of new medical products. In 2006, the FDA published the "Critical Path Opportunities Report and List," an analysis that identified 76 projects; if completed, these projects should dramatically improve medical product development.
  • Arizona Responds: The Governor of Arizona convened leaders from the University of Arizona, and SRI, International (a non-profit research institute in Palo Alto, CA) to meet with leaders from the FDA. From this meeting came a plan to create a new non-profit organization dedicated solely to support the FDA's Critical Path Initiative; in 2005, with a planning grant from the State of Arizona, Critical Path Institute (C-Path) was founded as a 501(c)(3) corporation based in Tucson, AZ with plans for additional offices in Rockville, MD.
    Critical Path Institute serves the public health as an independent agent marked by neutrality that is only possible because it does not accept funding from industry collaborators. Its operations are fully funded by the state and local governments in Arizona and private charitable foundations. C-Path operates under a Memorandum of Understanding with the FDA. C-Path has demonstrated its ability to bring together scientists from the FDA and the industry to identify new methods and tools that will enable the "faster, safer, smarter" development of new drugs, diagnostics and medical devices. Drs. Woosley and Cossman have published a review of the FDA's Critical Path Initiative and Dr. Janet Woodcock, Deputy Director of the FDA, and Dr. Woosley have published a progress report on the initiative and the role of C-Path. 3,4
  • Faster, Safer, Smarter: Some analysts have concluded that the decline in pharmaceutical productivity was inevitable because the "low hanging fruits" of medical advances have already been harvested; modern science requires that more money and time be spent to develop new products. However, recent history refutes this theory and proves that drug development can be safely accelerated if the environment is right for collaboration.

In the 1980's, when the average time required to successfully develop a drug candidate was greater than ten years and review times at the FDA for new products averaged 40 months, drugs for HIV/AIDs were developed in only 3.3 years (range 1.4-5) and review times averaged only 4.3 months (range 1.4-7.6).5 This was accomplished without compromising drug safety - i.e., none of the AIDS drugs have been removed from the market and all remain in use today. The rapid and safe development of these drugs was possible because the FDA and the industry, under tremendous pressure from patients and Congress, worked closely together to share and agree upon scientific advances that could speed these drugs into practice. A biomarker for HIV ("CD4 count" and later "viral load") was chosen as a way to identify appropriate subjects for clinical trials and as a measure of favorable response to new drugs.5 Drugs that were found to raise CD4 counts in blood tests were approved by the FDA with the stipulation that the pharmaceutical sponsors were required to show that the drugs also extended life - which they have.

1. Food and Drug Administration. Innovation or Stagnation: Challenges and Opportunity on the Critical Path to New Medical Products; http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html. 2004.
Internet Communication
2. Aaron Smith. The FDA'a higher bar on new drugs. CNN Money . 2-5-2008.
Electronic Citation
3. Woodcock J, Woosley R. The FDA critical path initiative and its influence on new drug development. Annu Rev Med 2008; 59:1-12.
4. Woosley RL, Cossman J. Drug development and the FDA's Critical Path Initiative. Clin Pharmacol Ther 2007; 81(1):129-133.
5. Feigal DW, Jr. Development of HIV/AIDS drugs in the US. Woosley R, editor. 2-2-2008. Personal Communication