The biopharmaceutical industry can bring new medicines to market in a faster, safer, and less expensive way than current government and industry policy allows. Recognizing this reality, the U.S. Food and Drug Administration (FDA) has taken a dramatic step to streamline drug development by incorporating new technologies. The FDA's Critical Path Initiative, announced in March 2004, has recommended evaluation of new ways to use genetic tools, faster computers, new imaging techniques, and electronic medical records in the drug evaluation process. This ongoing project, while still in its infancy, holds the potential to break down barriers between regulators and industry and to expedite the often complicated journeys of lifesaving medical innovations from researchers to regulators to patients.
In support of the Critical Path Initiative, the Center for Medical Progress at the Manhattan Institute convened 25 experts from industry, government, and the scientific community in a task force on the 21st century FDA. In spirited and wide-ranging discussions, participants considered how advances in genomics and other disciplines might be used to optimize the drug approval process. This working paper distills the problems, principles, and proposals that surfaced during that dialogue.
In our discussions, a general consensus emerged that FDA, scientific researchers, and pharmaceutical companies can collaborate to:
- Integrate biomarker validation into every stage of the regulatory review for drug, diagnostic, and biologic applications.
- Improve clinical trials by creating one standard for collecting and using data from electronic medical records.
- Utilize validated biomarker-based studies to assess the safety and effectiveness of specific drugs for specific subpopulations at specific doses.
- Articulate the importance of congressional appropriations sufficient to implement the FDA’s Critical Path activities, as well as providing the $5.9 million earmarked for Critical Path purposes in the FDA’s 2007 budget proposed by President George W. Bush.
This working paper is intended not as the final word on the Critical Path but as a springboard to continuing discussion and debate. Although this paper focuses on drug development, participants in the task force's discussions recognize that the FDA has vital responsibilities in other areas, such as bioterrorism and food safety. Nevertheless, the authors of this report believe that the Critical Path Initiative should be a priority within the FDA and within government. By steering us toward a drug approval process that is driven more by science and restricted less by regulation — by unleashing the powers of American enterprise and pathbreaking science — the Critical Path Initiative can improve health and save lives.