WASHINGTON, DC--(Marketwired - Dec 1, 2016) - The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the gene and cellular therapies and broader regenerative medicine sector, commends the U.S. House of Representatives' bipartisan passage of the 21st Century Cures Act.
ARM is particularly pleased the bill includes regenerative medicine-specific provisions intended to optimize the U.S. Food and Drug Administration's (FDA) approval pathways for regenerative medicine products, without reducing the agency's high approval standards for product safety and efficacy.
"This legislation maintains the FDA's appropriately high product approval standards, while providing for the flexibility to consider the unique attributes of these innovative products," said Michael Werner, executive director, ARM.
ARM has previously expressed concerns about proposals that sought to change approval pathways for regenerative medicine products by reducing, or in some cases, eliminating the FDA's regulatory authority, which could have allowed untested and unproven treatments to reach the market. ARM is pleased this proposal supports product development by optimizing FDA's regulatory pathway without reducing the Agency's authority.
The bill introduces, for the first time in the U.S., a specific Regenerative Medicine / Advanced Therapy (RMAT) Product designation. This specific acknowledgement of the importance of these technologies provides regenerative medicine and advanced therapy product sponsors with key benefits, including:
- Guaranteed interactions with the FDA
- Eligibility for priority review and accelerated approval
- Flexibility in the number of clinical sites used and the possibility to use patient registry data and other sources of "real-world" evidence for post-approval studies, pending agreement and approval from FDA
The bill also requires the FDA to work with sector stakeholders to identify ways to develop standards that aid in product development and evaluation, which ARM has asserted is essential to commercialization efforts and sector advancement.
With last night's passage in the House, the bill now moves to the U.S. Senate for vote next week.
About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 250 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org.