By Jacqueline Kirby, Vice President, US Government Affairs
9 February 2015
Congress recently moved biomedical innovation in the United States forward in a significant way, as the House Energy and Commerce Committee unveiled its draft 21st Century Cures Initiative legislation and the Senate HELP Committee released its “Innovation for Healthier Americans” report.
We at AstraZeneca support the 21st Century Cures Initiative as we noted last August. We believe it is an important step toward encouraging the discovery of cures and treatments for some of the most debilitating diseases and conditions while helping to ensure that the United States remains at the forefront of biomedical research.
The 21st Century Cures Initiative is designed to “take a comprehensive look at what steps we can take to accelerate the pace of cures in America.” The House E&C Committee examined “the full arc of this process – from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase,” as noted in the mission statement.
Upon initial review, we are pleased to see that the draft of legislation addresses many of the topics we included in our written recommendations to the Committee, including biomarkers, antibiotic drug development and reimbursement, utilizing real world evidence for regulatory decision-making, modernizing clinical trials (through encouraging broader use of Bayesian statistics and adaptive trial designs), and FDA review and evaluation of combination products.
AstraZeneca likewise applauds the Senate HELP Committee’s release of the “Innovation for Healthier Americans” report. “’Innovation for Healthier Americans’ is an important call to action, soliciting input and participation from the full universe of stakeholders interested and/or involved in medical innovation in America,” former FDA Commissioner Dr. Andrew von Eschenbach wrote in introducing the report. The report aims to examine the current drug development process, identifying inefficiencies in this process that stand in the way of bringing new medicines to patients and soliciting stakeholder feedback.
AstraZeneca is committed to working closely with members of Congress on the 21st Century Cures Initiative and on the related Senate FDA reform effort in the months ahead to ensure the United States remains a leader in biomedical research.