Bipartisan legislation introduced in the U.S. House and Senate would require the U.S. Food and Drug Administration (FDA) to lower some government barriers to patient access to regenerative medicines for debilitating diseases, wounds, and conditions.
The REGROW Act would “reduce barriers to medical innovation and accelerate the development of new regenerative medicine treatments, which have the potential to restore or establish normal function in damaged human cells, tissues and organs,” Sen. Mark Kirk’s (R-IL) press release stated on March 16, the day Kirk, Sen. Joe Manchin (D-WV), and Susan Collins (R-ME) introduced Senate Bill 2689.
The identical House version of the REGROW Act, House Resolution 4762, was introduced the same day by Rep. Mike Coffman (R-CO), Rep. Mark Takai (D-HI), and Rep. Morgan Griffith (R-VA). Each bill was immediately referred to committee and awaits further action.
The legislation would require “the FDA to collaborate with stakeholders to develop standards that will lead to manufacturing processes and controls for safe regenerative medicine products,” the release states.
Catching Up with Technology
Naomi Lopez-Bauman, director of health care policy at the Goldwater Institute, says the bills reflect federal lawmakers’ attempt to catch up with changing technology.
“The REGROW Act is an example of how lawmakers can better align the FDA approval process with twenty-first-century medicine,” Bauman said. “This proposal, as well as proposals to grant reciprocal approval, are important steps in discussing ways in which the current FDA approval process can reflect twenty-first-century medicine and, more importantly, providing more treatment options for doctors and their patients.”
Bauman cites Japan’s relatively fast approval of regenerative medicines as evidence of leadership in the field.
“Japan has already taken the lead in the area of regenerative medicine approval,” Bauman said. “Some regenerative medicine treatments are granted a seven-year conditional approval after the treatment has passed Phase 1 safety testing.”
Freedom to Choose Medicine
Bart Madden, author of Free to Choose Medicine, says the REGROW Act is a step toward allowing patients to access more effective drugs sooner than FDA currently allows.
“The REGROW Act is consistent with the ‘Free to Choose Medicine’ principle of early access after safety is verified and some initial efficacy shown,” Madden says. “We need freedom for early access to the most innovative new medical treatments that are far superior to existing FDA-approved treatments.”
Madden says ensuring patient access to better medicines should be a staple of the national conversation.
“Everyone, including the media, should focus on the appropriate goal of better medical treatments, delivered sooner, at lower cost—genuine value to patients,” Madden said. “Every American should have the right to make their own informed decision that can improve health and save lives.”
Josh Thomas ([email protected]) writes from Toledo, Ohio.
Joseph V. Gulfo, Jason Briggeman, and Ethan C. Roberts, The Proper Role of the FDA in the 21st Century, Mercatus Center, February 2, 2016: https://heartland.org/policy-documents/proper-role-fda-21st-century