Senators Lamar Alexander and Richard Burr (R-N.C.) on Thursday released a report on the challenges to getting safe treatments, devices and cures to patients more quickly and effectively, examining what is working, and what isn’t, at the Food and Drug Administration and the National Institutes of Health.
The senators are soliciting feedback on their report as Chairman Alexander and Ranking Member Patty Murray (D-Wa.) begin a major initiative in the Senate health committee —including a bipartisan working group and a series of hearings—to examine the time and cost currently involved with the drug and medical device discovery and development process, and how to better align public policies to support medical innovation.
Senator Alexander said, “America is home to the sharpest scientists and boldest researchers who are every day finding cutting-edge cures, treatments and devices to help make sick people well or make life easier for the disabled.
The challenge is that our process for developing and reviewing these products is out of date and unable to match the pace of discovery, so American patients are waiting too long for relief. With the release of this report, we begin our work in the Senate health committee to modernize that review process and make Americans healthier.”
Senator Burr said, “For decades, our nation has led the world in medical innovation, but the challenges of maintaining this edge have never been greater,” said Burr. “Our report asks a simple but critical question – how can we do it better? We are in an exciting era of medicine that holds tremendous potential to improve treatments and outcomes for patients. But to realize this potential, we must ensure that our nation’s discovery and development processes are working as well as possible. I am committed to working with my colleagues to ensure that the work of North Carolina’s researchers and innovators is reaching America’s patients in as timely a manner as possible, so that patients across our nation are able to benefit from cutting-edge medical products.”
In the executive summary, the senators wrote: “This report aims to examine the current process of drug and device development and identify the inefficiencies that stand in the way of a modern development and review process. We take a close and honest look at what is, and is not, working well at the NIH and FDA. We want to know what successes we can replicate, and what failures must be learned from and fixed.
“Our goal is simple and ambitious – to work in a bipartisan way with members of the HELP Committee to align public policies to support accelerating medical innovation and patient access to medicines and medical technologies. Science has never held greater potential to improve the quality of life and outcomes for America’s patients. In order to fully realize this exciting potential, we must identify, candidly assess, and confront existing factors that may be stifling efforts to innovate.
The senators requested feedback on the report by Feb. 23. Ideas should be sent to Innovation@help.senate.gov. These comments will be shared all members of the Senate HELP Committee.
Click here to read the report: http://www.help.senate.gov/imo/media/Innovation_for_Healthier_Americans.pdf