FDA Critical Path Initiative: Crossing the Red Tape Sea

The FDA’s “Critical Path” initiative is focused on reforming the regulatory path to medical product development, making it more predictable, shorter, effective, and affordable. The agency’s March 2004 report, Innovation/Stagnation:  Challenge and Opportunity on the Critical Path to New Medical Products, “…outlines three phases in drug development—ensuring safety, demonstrating efficacy, and manufacturing effective treatments—that may require reform. Tools for testing safety have changed little in the last few years, the report says. Trials to determine efficacy are a source of ‘innumerable failures,’ and problems in designing, characterizing, and scaling up products ‘routinely derail’ or delay development programs and keep needed treatments from patients.”

The FDA invited industry, patient groups, academic researchers, and other stakeholders to help identify and prioritize the most pressing problems in the drug development process and the areas that provide the greatest opportunities for rapid improvement and public health benefits. Based on this input, the FDA developed a national Critical Path Opportunities List identifying the most important challenges, is focusing scientific research on these challenges, and is collaborating with all stakeholders to improve the process for getting new and better treatments to patients by streamlining the critical path from laboratory concept to commercial product. This involves:

• Introducing new processes, techniques and technologies, and best practices to design better clinical trials. This will reduce development costs, increase opportunities for smaller bio-techs currently daunted by the expense, and improve the likelihood of success.

• Letting treatment sponsors know what information is required of them at each stage of development along the critical path.

• Creating a new generation of performance standards and a product development “toolkit” containing powerful animal or computer-based  predictive models and biomarkers, and new clinical evaluation techniques to better assess safety and effectiveness.

• Ensuring new tools move forward new scientific innovations, building on knowledge delivered by recent advances in science (e.g. bioinformatics, genomics, imaging technologies, and materials science).

• Building a knowledge base not just on ideas from biomedical research, but on reliable insights into the pathway to patients.

• “It’s in everybody's interest to reduce the cost of drug development and to increase the likelihood of success.” said Alastair J.J. Wood, assistant vice chancellor for research at Vanderbilt University.

  To read about FDA's Critical Path Initiative