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Advancing America’s Health. Advancing Medical Breakthroughs.

Posted on: 03/17/2004

Advancing America’s Health. Advancing Medical Breakthroughs.

March 16, 2004
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"Critical Path" Paper Calls for Academic Researchers, Product Developers, and Patient Groups To Work With FDA To Help Identify Opportunities to Modernize Tools for Speeding Approvable, Innovative Products To Improve Public Health

FDA today issued a major report identifying both the problems and potential solutions to the daunting task of ensuring that the unprecedented breakthroughs in medical science are demonstrated to be safe and effective for patients as quickly and inexpensively as possible. Entitled "Innovation or Stagnation? -- Challenge and Opportunity on the Critical Path to New Medical Products," the report carefully examines the "Critical Path" of medical product development -- the crucial steps that determine whether and how quickly a medical discovery becomes a reliable medical treatment for patients.

The report examines the development path for all types of medical products – drugs, biologics and medical devices – to identify what problems exist and what steps need to be taken to bring the critical path into the 21 st Century. The report particularly focuses on the unique opportunities for FDA to collaborate with academic researchers, product developers, patient groups, and other stakeholders to make the critical path much faster, predictable, and less costly.

"Today, as never before, we face a tremendous potential for new medicines to prevent and cure diseases, but fewer new products are actually reaching the FDA," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "With so much promising technology in development in the clinical labs, ranging from engineered tissues to new kinds of biologicals and genomics-based treatments, we need to turn the process of bringing these technologies to patients from a costly and time-consuming art form to a well-understood science. FDA intends to launch a new effort with our public and private partners in improving the public health to turn the critical path of product development into a fast, certain, and more affordable process, to improve access to better treatments for all Americans. Our researchers have a unique vantage point on scientific challenges that cause delays and failures in product testing and manufacture. This thoughtful report outlines how critically important it is that the agency work with academics and industry to identify ways the medical product development process can be improved to keep pace with basic science innovation."

The report requested by Dr. McClellan and Deputy Commissioner Lester Crawford, D.V.M., was prepared under the direction of Janet Woodcock, M.D., Director, Cross Center Initiatives Taskforce, with the involvement of CDRH Director Dr. David Feigal, CBER Director Dr. Jesse Goodman, and Acting CDER Director Dr. Steven Galson, as well as key FDA staff. It carefully examines the current state of the critical path between medical innovation and medical product development and found disturbing trends indicating systemic problems.

The report notes that despite notable advances in innovative fields of biomedical research as genomics, proteomics and nanotechnology, there has been a downward trend in recent years in the number of innovative medical product applications to FDA and its counterpart agencies throughout the world. While the number of new product applications and approvals was modestly higher in 2003, the fact remains that most of these new scientific fields are not yet having a fundamental impact on patient care. Although these and other problems are attributable to a variety of factors, FDA's report focuses on one important cause – that new science is not being adequately harnessed to guide the technology development process in the same way that it is accelerating the discovery process.

The report applauds the important advances triggered by recent investments in basic and translational research, and concludes that a third type of research, targeting the process of creating safe and effective products from new scientific discoveries, is urgently needed to complete the path from discovery to patient. In FDA's view, the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences.

To meet this challenge, FDA calls for a new focus on modernizing the tools that applied biomedical researchers and product developers use to assess the safety and effectiveness of potential new products, and the manufacturing tools necessary for high-quality mass production of cutting-edge therapies. The report describes the need for the FDA, together with academia, patient groups, industry, and other government agencies, to embark on an aggressive, collaborative research effort to create a new generation of performance standards and predictive tools that will provide better answers about the safety and effectiveness of investigational products, faster and with more certainty. Key to this effort will be the collaborative development of a Critical Path Opportunities List, which will identify those areas of product development that could most benefit from innovative approaches and emerging technological advances, to fundamentally change and modernize the critical path for medical product testing and manufacture in the 21st Century.

FDA also intends to make internal changes and implement new collaborations to realize these priority opportunities. This action promises not only to bring medical breakthroughs to patients more quickly, but to do so in ways that ensure greater understanding about how to maximize patient benefits and minimize their risks. Moreover, the efficiencies gained through these innovations could bring significant economies that could provide both more affordable medical products and a much greater payoff from greater predictability and speed for investment in medical research and development.

The report notes that FDA is uniquely suited to take a major role in this effort because of its experience overseeing medical product development, assessment and manufacturing/marketing; its vast clinical and animal databases; and its close interactions with all the major players in the critical path process. This initiative is not a fundamental departure for FDA, but rather builds on the agency's proven "best practices" for expediting the availability of promising medical technologies. Examples of such efforts include:

Developing new animal models for speeding the assessment of safety and effectiveness of next generation medicines against anthrax, smallpox and other bioterrorist threats. Developing a four company-sponsored 40,000 patient study of the comparative accuracy of digital and conventional mammography – a study no one company could develop or mount, but which is of vital importance to millions of women. Working with the U.S. Centers for Disease Control and prevention, industry and America's blood banks, FDA rapidly developed and made available the target viral assays required for the manufacture of blood screening tests for West Nile Virus. Using the unique incentives of the Orphan Drug Act and FDA's knowledge of the drug development process to collaborate with industry, government and patient groups to produce more than 250 approvals of Orphan Drugs over the last 21 years. These products, in the aggregate, treat more than 12 million patients in the US. The next steps in this initiative include a series of workshops and meetings, to start development of the National Critical Path Opportunities list and to identify the key priorities. In addition to working with stakeholder groups, the agency also plans to realign its internal project emphasis, whenever possible to promote these goals.

"FDA is fully committed to moving this process forward. Bringing the stakeholders together is vital for identifying ways to overcome the obstacles to new product development in the interest of the public health, " said FDA Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D., "Our April Science Board meeting with stakeholders will be devoted to this topic, and that will be just the first step as we move this important initiative forward."


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