BIO President Lauds Critical Path Initiative to Streamline Drug Development

WASHINGTON, D.C. (March 17, 2006) -- Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), lauded the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) today on the release of FDA’s Critical Path Opportunities White Paper and List as an important step in building momentum for the Critical Path Initiative.

“FDA is taking a significant step toward working with us to transform the vision of personalized medicine into a reality. Today’s report cited substantial opportunities for better diagnoses, more efficient drug development, and safer and more effective therapies, such as the identification and qualification of new safety and efficacy biomarkers.  These advances will play an essential role in helping industry, regulators and other stakeholders deliver on the promise of personalized medicine,” Greenwood said.  “For people living with unmet medical needs, overcoming road blocks to getting new products developed, approved, and utilized can be matter of life or death.”

The Critical Path Initiative is the result of the FDA’s investigation into the downward trend in applications for drugs, biologics and medical devices. The first report of the series, released in March 2004, studied the slowdown in innovative medical therapies reaching patients. In fact, today the failure rate of new products in late stage development is higher than 15 years ago.  This is a trend that must be reversed.

“Biotechnology companies are leaders in modernizing the product development sciences that turn biomedical discoveries into breakthrough products. These companies are also advancing research that will enable better healthcare through personalized medicine. In this report, the FDA is acknowledging that personalized medicine will revolutionize healthcare in the future,” Greenwood said.

In January 2006, BIO and a coalition of 21 patient groups sent a letter to HHS Secretary Mike Leavitt in support of the Critical Path Initiative.  BIO also supports the President’s request for $5.94 million in the FY 2007 budget for Critical Path, and urges Congress to ensure that Critical Path programs receive the priority and appropriations needed for success.  It is important that where opportunities are identified and new tools are developed, these replace, not add to existing tools.  To view our letter, visit

“BIO looks forward to working with FDA, patients and other stakeholders to take advantage of these opportunities to foster greater access to innovative therapies,” Greenwood concluded.  “We thank Health and Human Services Secretary Mike Leavitt and Acting FDA Commissioner Andy von Eschenbach for making the Critical Path Initiative a high priority.”

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.