FDA's Critical Path Initiative

Transforming the way FDA-regulated products are developed, evaluated, manufactured, and used

 

The Critical Path Initiative (CPI) is FDA's national strategy for driving innovation to modernize the sciences through which FDA-regulated products are developed, evaluated, manufactured, and used.

Launch

The Initiative was launched in March 2004, with the release of FDA's landmark report Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. The publication diagnosed the reasons for the widening gap between scientific discoveries that have unlocked the potential to prevent and cure some of today's biggest killers, such as diabetes, cancer and Alzheimer's, and their translation into innovative medical treatments. 

Sounding the alarm on the increasing difficulty and unpredictability of medical product development, the report concluded that collective action was needed to modernize scientific and technical tools--and harness information technology to evaluate and predict the safety, effectiveness, and manufacturability of medical products. The report called for a nationwide effort to identify specific activities all along the critical path of medical product development and use, which, if undertaken,would help modernize the critical path sciences. 

In March 2006, HHS Secretary Leavitt and FDA's Commissioner announced the release of FDA’s Critical Path Opportunities List. The List, which was developed with broad contribution from the public, described areas in which the product development sciences had the greatest need for improvement. 

It listed 76 tangible examples of areas where new scientific discoveries—in fields like genomics, imaging, and bioinformatics (the analysis of biological information using computers and statistical techniques)--could be applied during development to improve the accuracy of the tests that predict the safety and efficacy of potential medical products.

Following the report's release, FDA launched a major drive to facilitate collaborations with all stakeholders to tackle identified issues. During 2006 and 2007, numerous innovative projects were undertaken as part of CPI.

CPI's Widening Scope

The impact of 21st century challenges

Globalization, rapidly evolving technologies, and emerging areas of science are having an increasing impact on all FDA-regulated products. For this reason, CPI has gradually expanded its scope, leveraging the knowledge we've gained from new scientific fields to enhance the tools FDA uses to evaluate veterinary products, food, and food ingredients (e.g. new rapid tests to determine biological and chemical contamination of animal-derived foods). Complex new technologies, such as genetically engineered plants and animals, and cloning, are bringing new challenges to veterinary medicine that require sophisticated, cross-disciplinary scientific evaluation.

Moving to a fully integrated electronic infrastructure

New bioinformatics approaches are making it possible for us to put in place the cutting-edge information systems that are critical to supporting medical innovation and public health safety. CPI's 2008 Annual Report highlights the work FDA and its collaborators have done to move toward a flexible, fully integrated electronic infrastructure that is capable of receiving and managing crucial product data in real time! These projects are streamlining the information tracking systems for all FDA-regulated products, including reporting of adverse events and tracking human and animal food contamination.

CPI -- FDA's National Strategy for Driving Innovation

The Critical Path Initiative has become the main engine behind FDA's drive to create 21st century tools and methods for monitoring food, medicines, and treatment approaches. In the short time since its inception, the Initiative has seen the number of its projects grow from 40 in 2006 to 95 in 2009. FDA is building on its unique position to collaborate  with other federal agencies, patient groups, academic researchers, industry, and other stakeholders to identify areas ripe for improvement and to coordinate, develop, and/or disseminate solutions to scientific hurdles that are impairing the efficiency of developing and evaluating FDA regulated products.

As existing resources allow, we are continuing to initiate partnerships to address some of these priority scientific hurdles. We have posted descriptions of some of our Critical Path activities on this Web site (see the Critical Path Follow-up list), and we will be adding new activities as they begin to take shape [Critical Path Opportunities Initiated During 2006]. It is these kinds of activities that are moving the critical path sciences into the 21st century.

FDA will continue to provide leadership and coordination to this important effort. The Critical Path Initiative is one of the Agency’s top priorities. "The Critical Path Initiative is the vehicle that will take us into the 21st century," said Dr. Von Eschenbach, Commissioner of FDA. "It is fostering strong, sustained scientific advances that will enhance the health and well-being of all Americans."