BIO and 21 Patient Groups Issue Letter Supporting FDA’s Critical Path Initiative

WASHINGTON, D.C. (January 13, 2006) – The Biotechnology Industry Organization (BIO) and a coalition of 21 patient groups have sent a letter to Health and Human Services Secretary Mike Leavitt in support of the Food and Drug Administration’s Critical Path Initiative.

“Critical Path is an initiative that holds great promise for improving the health of all Americans by accelerating the development of innovative safe and effective treatments, and by helping usher in the era of personalized medicine: getting the right medicine to the right patient, at the right time and in the right dosage,” Jim Greenwood, BIO’s president and CEO, said in a statement to Leavitt.

The Critical Path Initiative grew out the FDA’s investigation into the downward trend in applications for drugs, biologics and medical devices. The FDA concluded that reversing the decrease in applications would require modernization of the medical product development process – the Critical Path – to make product development more predictable and less costly.

“Under the auspices of the Critical Path, the FDA and stakeholders will work together to develop the tools necessary to usher in the new era of personalized medicine, such as new validated safety and efficacy biomarkers and new ways to measure variation in patient response,” Greenwood said. “For people with devastating diseases and disabilities, road blocks to getting new products developed and approved can be matter of life or death.”

BIO and the coalition also urge Leavitt to ensure that Critical Path programs receive the priority and resources needed for success.

The FDA is expected to release the second Critical Path report and a Critical Path Opportunities White Paper soon.

Greenwood thanked Leavitt, HHS deputy secretary Alex Azar and acting FDA commissioner Andy von Eschenbach for making the Critical Path Initiative a high priority.

The view the BIO’s cover letter, visit; and visit to view the secretary’s letter.

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.