Weekly Column by Lamar Alexander: Getting Medical Devices and Treatments from the Lab to the Patients That Need Them the Most

Posted on March 13, 2015

     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. 

     However, the challenges of maintaining this edge have never been greater. Our process for developing and reviewing these products is out of date and unable to match the pace of discovery, leaving American patients waiting too long for relief. 

     This year, the Senate health committee, which I chair, began work to modernize that development process to help make Americans healthier. This week, we held the first hearing on our bipartisan initiative to look at how we get drugs, devices and treatments from the discovery process through the regulatory process into our medicine cabinets and doctors’ offices, and to discuss ways Congress can help improve this process.

     This work will touch the life of almost every single American, from a very ill patient who has run out of treatment options and is counting on the most cutting-edge drug, to an active child with asthma who’s hoping to run faster and farther with the aid of a new drug. 

     In late January, Senator Richard Burr and I released a report titled “Innovation for Healthier Americans” that examined the process we have in place today for drug and device development. 

     The report has five main themes:

1. It costs too much to bring medical products through the pipeline to patients.

2. As science and technology advance, the discovery and development process takes too long for medical products to make their way to patients.

3. The Food and Drug Administration’s (FDA) responsibilities have grown to include many activities unrelated to the core function of regulating medical products to advance the public health.

4. The disparity in scientific knowledge at FDA and the fast pace of biomedical innovation are slowing, and in some cases, stifling innovation in American medicine.

5. A working FDA is essential to continuing biomedical innovation in the United States and maintaining America’s global leadership in medical innovation.

     In the words of Andrew Eschenbach, MD, the former Commissioner of the FDA and Director of the National Cancer Institute: “We stand on the cusp of a revolution in health care. Advances in molecular medicine will allow us to develop powerful new treatments that can cure or even prevent diseases like Alzheimer's and cancer. Tomorrow's high-tech cures can also slash health-care costs and eliminate ineffective treatments.”

     Our goal is simple but ambitious: to work in a bipartisan way to make sure policies support medical innovation and patient access to important medicines and medical technologies.

     If we do it right, our work here will help improve the lives of every single American.