11 March 2015
On March 10, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee held its first hearing on its “Innovation for Healthier Americans” initiative. Dr. Francis Collins, Executive Director of the National Institutes of Health (NIH) and Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration (FDA) were the witnesses at the hearing. This Senate effort to accelerate the development of new cures and treatments for patients is a similar, parallel effort to the U.S. House Energy & Commerce Committee’s 21st Century Cures Initiative. Both of these Congressional endeavors share a common goal with President Obama’s Precision Medicine Initiative, which involves increasing funding for multiple federal agencies in order to improve health information technology interoperability, while expanding and optimizing treatments for cancer in a variety of ways.
AstraZeneca supports the Senate HELP Committee’s Innovation for Healthier Americans Initiative. We provided initial recommendations to the Committee, encouraging them to focus on exploring potential enhancements to the qualification pathway for certain drug development tools, such as biomarkers. We also encouraged the exploration of ways to get the FDA to more readily embrace modern clinical trial designs and methodologies. We are encouraged that the Senate HELP Committee and the House Energy & Commerce Committee are interested in tackling this important issue and we stand ready to work with both Committees in support of their efforts to advance medical innovation during this Congressional session.
As articulated by Sen. Lamar Alexander (R-TN,) the Chair of the Committee at the hearing, the goal of this bi-partisan effort is the identification of what the Congress, along with the President, can do to reduce the cost and the amount of time it takes to discover a medicine and deliver it to patients.
While much of the discussion at the hearing centered on the need for adequate and consistent funding for the NIH and the basic science it conducts, there was also discussion of the important role that biomarkers can play in advancing personalized therapies for patients. Both Dr. Collins and Dr. Hamburg indicated their appreciation for having the opportunity to discuss what more can be done to drive innovation in our nation, with Commissioner Hamburg stating that she “wants the FDA to be a gateway, not a barrier, to getting safe and effective medicines to patients.”