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Streamlining the federal approval process will reduce the wait times for patients to receive lifesaving medical devices. This bipartisan proposal will also allow San Diego’s medical device industry to put more resources into developing new devices as it continues to grow our region’s economy and create high-quality jobs.– Rep. Scott Peters (D-CA)
We applaud Representative Todd Young and Representative Scott Peters for their work on legislation to provide access to the latest medical device technology to patients sooner. Today, Medicare covers certain medical costs for patients participating in FDA-approved clinical trials. Although drug trials approved by the FDA automatically are covered by Medicare, medical device trials must go through a second coverage determination by a separate agency. This additional process adds both unnecessary time and cost to the conduct of medical device clinical trials and is especially challenging for small, start-up companies that do not have the resources necessary to navigate these bureaucratic hurdles. --Steve Ferguson, Chairman of Cook Group
America has a long tradition of excellence and innovation in patient care, and neurosurgeons have been on the cutting edge of these advancements. However, for a number of reasons,
American medical innovation is at serious risk and Congress must take the necessary steps to remove inappropriate regulatory burdens on medical device innovation, which hurt America’s competitive advantage in healthcare advancements, and delay or deny appropriate care for patients. Your legislation is an important step that will help pave the way for patients to have access to new and innovative life-saving technologies... Removing this bureaucratic barrier should
help lower the lower the costs and time associated with conducting clinical trials and
provide Medicare patients the opportunity to participate in research that could lead to life-saving surgical treatment of nervous system disorders such as stroke, degenerative spine disorders, Parkinson’s and Alzheimer's disease. Thank you for your
leadership on this issue. --
H. Hunt Batjer, MD, President, American Association of Neurological Surgeons
H.R. 4714 would eliminate the requirement for separate Medicare approval of trials that have been approved by the FDA. Removing this costly, time-intensive and unnecessary bureaucratic obstacle will increase the number of clinical trials available to Medicare patients, as well as
support the important goal of advancing medical research. CLSA applauds your leadership on this important legislation and we are
pleased offer our support for H.R. 4714, the Removing Barriers to Clinical Research Act of 2016. --
Todd Gillenwater, Executive Vice President, California Life Sciences Association (CLSA)
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