On January 27, 2015, members of the House Commerce and Energy Committee unveiled a set of legislative proposals aimed at speeding up the development of new medical technology. The 21st Century Cures panel, a bipartisan committee led by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) prepared the report after eight months of roundtable discussions with medical stakeholders across the country. A legislative section-by-section summary document and a more general summary document outline the panel’s ideas to streamline clinical trials, speed up production of certain drugs and devices, and better incorporate patients’ experiences when designing new treatments.
A focus of the report includes establishing a process for the designation and expedited review of “breakthrough technologies” with the potential to address unmet medical needs. The report also includes proposed reforms to medical device review and regulations, including a streamlined 510(k) process and extensions to the Humanitarian Device Exemption. Other areas of the report focus on accelerating scientific discovery through additional funding to the National Institute of Health.
The proposals are a work in progress and include many sections with placeholder language. It remains to be seen whether these ideas will develop into successful legislation.