CAMI Applauds FDA’s Biomedical Innovation Report

WASHINGTON, DC (October 11, 2011)– The Council for American Medical Innovation today commended Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration, on the release of the new report, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients,” which outlines immediate first steps the FDA will take to further promote biomedical innovation. 

"These first steps present a solid set of initiatives that will help the FDA achieve the important goal of facilitating greater biomedical innovation while protecting the health of Americans and the safety of the medical devices and medicines they use,” said Former House Majority Leader Dick Gephardt, co-chair of CAMI. “The FDA plays a critical role in medical innovation in this country, and we applaud Commissioner Hamburg for launching such a significant effort to improve the FDA’s performance as a driver of innovation.”

The report launching the FDA’s new Innovation Initiative recognizes the importance of a breadth of efforts, such as development of personalized medicine, a rapid drug development pathway, workforce training and improving clarity and consistency in the medical device review process, to the Agency’s ability to foster innovation. These initiatives are consistent with CAMI’s policy recommendations and CAMI supports them. The Council also believes that there are additional steps the Commissioner should take that will only serve to strengthen these initiatives.

Specifically, CAMI urges the FDA to develop a framework for engagement on improved benefit-risk analysis during the approval process to encourage innovation and expedite the delivery of safe, new treatments and devices to the patients who need them most. Additionally, the Council salutes proposals in the report to improve collaboration in areas of regulatory science, but believes that these must include greater patient input in order to be successful.

“Innovation is the best way to add value to our nation’s health care system – it adds value to the health of our citizens and the health of our nation,” said Governor Mike Leavitt, co-chair of CAMI. “The FDA can be a positive force in driving biomedical innovation, and this report underscores the Agency’s commitment to that effort. We congratulate Commissioner Hamburg and her team on this report, and look forward to working with them on this important effort.”

For more information on the Council for American Medical Innovation and to view the report, visit www.americanmedicalinnovation.org.

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Media Contact:  Teresa Schofield, 202-347-7516, teresa.schofield@americanmedicalinnovation.org