Washington, D.C. – The Bipartisan Policy Center issued the following statement by Janet Marchibroda, director of BPC’s health innovation initiative, regarding the bipartisan, bicameral introduction of the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act of 2016 (S. 2689 / H.R. 4762).
“BPC commends Sens. Mark Kirk (R-IL), Joe Manchin (D-WV), Susan Collins (R-ME) and Reps. Mike Coffman (R-CO), Mark Takai (D-HI), and Morgan Griffith (R-VA) for their collaboration and introduction of the REGROW Act.
“Regenerative cell therapy—which involves the use of cells to restore healthy organ and tissue function—represents one of the most promising areas for the next generation of groundbreaking treatments. The REGROW Act—which aligns with recommendations included in BPC’s recent report—Advancing Regenerative Cellular Therapy: Medical Innovation for Healthier Americans—modernizes FDA’s current regulatory approach toward safe and effective cell therapies, while protecting approval pathways under sections 351 and 361 of the Public Health Service Act.
“Europe and Japan have outpaced the United States in modernizing their policies to grant patient access to safe cell therapies. As a result, patients are forced to seek treatment overseas and U.S. companies are increasingly making investments in other parts of the world.
“The United States has a strategic and scientific imperative to regain its leadership in this area. We commend the bipartisan cooperation and leadership on this important legislation which will pave the way for scientific advances in cardiology, neurology, oncology, ophthalmology, and orthopedics, and promising new approaches for addressing those with Alzheimer’s disease, Parkinson’s disease, diabetes, and cancer.”
Under the leadership of former Senate Majority Leader Bill Frist, MD, and former Rep. Bart Gordon, BPC has released numerous recommendations to improve the medical product development process, improve regulatory clarity, strengthen the FDA’s ability to carry out its mission, and increase investments in treatments for unmet or public health needs. BPC has also been providing technical assistance to the Senate Health, Education, Labor, and Pensions Committee on ways to advance medical innovation. One of BPC’s ten priority areas focuses on the need to improve regulatory clarity and advance regenerative cell therapy in the United States.
Janet Marchibroda is available for comment.