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FDA | FDA Centennial
January 2007 — The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured.
The Initiative was launched in March 2004, with the release of an important report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products [http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf]. The report diagnosed the scientific reasons for the recent decrease in the number of innovative medical products submitted for approval—puzzling in light of recent advances in biomedical sciences and disappointing from a public health perspective. The report noted with concern the rising difficulty and unpredictability of medical product development and called for a concerted effort to modernize the scientific tools (e.g., in vitro tests, computer models, qualified biomarkers, and innovative study designs) and harness the potential of bioinformation used to evaluate and predict safety, effectiveness, and manufacturability of candidate medical products. The report also called for a national effort to identify specific critical path activities that, if carried out, would help modernize the critical path sciences. The goal of this effort is to reap the expected public health benefits from promises of biomedical advances of the 21st century.
In March 2006, HHS Secretary Leavitt and then Acting FDA Commissioner Andrew von Eschenbach announced the release of FDA’s Critical Path Opportunities List [http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_list.pdf]. The List, which was developed with extensive public input, describes the areas of greatest opportunity for improvement in the product development sciences and provides 76 concrete examples of how new scientific discoveries—in fields such as genomics and proteomics, imaging, and bioinformatics—could be applied during medical product development to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products.
The Critical Path Initiative is not limited to the sciences that support human medical product development. Scientific advances hold the potential to improve the tools FDA uses to evaluate the safety and efficacy of human and veterinary products as well as the safety and nutrition of food and food ingredients (e.g., new rapid tests for biological and chemical contamination of animal-derived foods, technologies for detecting and mitigating the microbial contamination of food, analysis technologies for assessing the safety and nutritive value of foods and food ingredients). Complex new technologies are bringing new challenges to veterinary medicine (e.g. genetically engineered plants and animals; cloning). These technologies require sophisticated cross-disciplinary scientific evaluation. In addition, although fewer traditional antimicrobials are being developed, infectious diseases continue to rank among the highest incidence of diseases in animals. There will be a need for evaluating the safety and effectiveness of new technologies aimed at reducing various pathogens. For example, a therapeutic intervention for the reduction of E. coli O157:H7 in cattle immediately prior to slaughter would, in conjunction with other risk management interventions during the slaughter and processing of beef, reduce the exposure of humans to E. coli O157:H7, which is a direct opportunity for a public health benefit.
In another area, new bioinformatics approaches could greatly enhance the interoperability of information tracking systems in the healthcare environment for all regulated products (e.g., adverse events reporting).
FDA is building on its unique position to work 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 [http://www.fda.gov/oc/initiatives/criticalpath/opportunities06.html]. 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."