lance. The implementation of the confidentiality agreement was planned to take place in several stages and is described in the implementation plan finalized in September 2004 (FDA and EMEA, 2004).

FDA announced that the agency would partner with the Agency for Healthcare Research and Quality (AHRQ) to launch an effort aimed at increasing research collaboration and to foster communication between the two agencies in December 2005 (FDA News, 2006b). FDA leaders stated that the collaboration will increase their understanding of health outcomes of prescription drugs, which will lead to better information to provide to the public. One component of the collaboration was assignment of a member of senior CDER leadership to a 12-month detail at AHRQ’s Center for Outcomes and Evidence as senior adviser in pharmaceutical outcomes research (FDA News, 2006b).


In March 2004, FDA released the report entitled Innovation or Stagnation?—Challenge and Opportunity on the Critical Path to New Medical Products (the Critical Path Initiative) (FDA, 2004). The report discussed the lack of innovative technologies and science in recent years to help to make drug development less expensive and more efficient. The goal of the CPI is to make safe and effective treatments available to the public quicker by using scientific innovations. The three dimensions outlined in the CPI report are safety assessment, evaluation of medical utility, and product industrialization.

FDA called for assistance from the public, academic researchers, funding agencies, and industry to help to reach that goal because it does not believe that it can get there alone. A major objective of the CPI is to encourage new and increased collaborations among a broad array of experts to develop innovative tools.

To reach its goal, FDA has partnered with the World Health Organization, the Bill and Melinda Gates Foundation, biotechnology research firms, AAMC, and others. After receiving feedback from those and other stakeholders, FDA released the Critical Path Opportunities Report in March 2006 to identify the initiative’s six kinds of priority-targeted research. One related to safety is the use of biomarkers to predict the performance of a product during development and thus reduce uncertainties about safety or effectiveness. If the biomarkers can be identified, validated, and shown to improve health outcomes, FDA believes that these priorities “will increase efficiency, predictability, and productivity of new medical products” (FDA, 2004, 2006b).

The main element related to drug safety in the CPI is improving tools for assessing safety to detect drug safety issues as early as possible. Today,

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