Washington, D.C. – The Bipartisan Policy Center issued the following statement by Janet Marchibroda, BPC’s Health Innovation Initiative director, on the announcement by Senate Health, Labor, Education, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) to advance bipartisan medical innovation legislation through the committee:
“We commend the Senate HELP Committee’s step-by step pragmatic strategy for advancing bipartisan legislation this year after nearly a year of tireless work following the House 21st Century Cures Initiative of 2014-15.
“Continued momentum to pass legislation over the next several months is essential if we are to realize our goals of delivering more safe and effective treatments and cures to patients. This will require improving medical product development, bolstering the Food and Drug Administration (FDA) with the expertise and capacity to carry out its core mission effectively and in pace with rapid innovation, and creating greater regulatory clarity and coordination where needed.
“Two of the bills slated for markup—the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act and the Combination Products Innovation Act—are perfect examples of where regulatory clarity and coordination are needed and achievable. The policy approaches in these bills are also in line with recommendations by BPC’s Health Innovation Initiative in 2013 and its 2015 report, FDA: Advancing Medical Innovation.
“We also applaud the Senate HELP Committee’s focus on precision medicine, interoperability of electronic health records, and ensuring patients have access to their health information. Greater interoperability and electronic information sharing are needed to support increasing consumer demands, the information needs of delivery system and payment reforms, and biomedical innovation. BPC released an issue brief and hosted an event on these topics on December 8, 2015.
“BPC looks forward to continuing to provide input and technical assistance to the Senate HELP Committee and its members as the process moves forward. We are encouraged by this innovative approach to advance the bills identified for markup and others nearing introduction in the Senate, including those focused on advancing regenerative cellular therapy.”