Legislators Seek New Regulatory Tools, Framework for Regenerative Medicine

Posted 30 April 2014 By Alexander Gaffney, RAC

New legislation introduced in the House of Representatives this week seeks to develop a comprehensive framework capable of allowing the "rapid approval" of regenerative medicine products by the US Food and Drug Administration (FDA).

While the bill, the Regenerative Medicine Promotion Act (RMPA) of 2014, does not define the term "Regenerative medicine," it is defined by the National Institutes of Health as, "the process of creating living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects."

The sponsors of the RMPA say they hope advancements in regenerative medicine might allow scientists to grow new organs and tissues, treat a wide range of diseases and conditions, and even heal paralyzed patients or soldiers with catastrophic wounds suffered in battle.

A national strategy, the bill's sponsors wrote, "is critical to ensure that this technology fulfills its potential to cure and treat diseases and disabilities, reduce overall health spending, and promote economic growth."

Devising a National Strategy

The bill looks to establish such a strategy in three ways: Through grants for research, the coordination of federal efforts and a new focus on regulation at FDA.

For example, FDA would hold a seat on a new "Regenerative Medicine Coordinating Council," which would be charged with preparing recommendations on a national strategy on regenerative medicine, including the development of drugs, biological products, medical devices and biomaterials.

Those products are all ultimately regulated by FDA, and so the council would also be charged with recommending ways FDA's regulatory processes could be improved to accommodate safe and effective regenerative medicine products.

The RMPA also calls for the involvement of the Cures Acceleration Network (CAN) in advancing regenerative medicine. CAN was formed in 2010 under the Patient Protection and Affordable Care Act (PPACA, or "Obamacare"), and is a sub-unit of NIH. As envisioned by NIH and legislators, it is supposed to be a research accelerator, awarding grants to seed outside investment in tools that can help accelerate product development.

The bill would permit CAN to perform clinical trials in support of regenerative medicines pursuing FDA approval under an approved clinical trial application (such as an investigational new drug application or an investigational device exemption).

Regulatory Science

The RMPA also would permit direct the secretary of the Department of Health and Human Services to direct grants-at his or her own discretion-to FDA in support of regulatory science research related to regenerative medicine, such as the development or evaluation of new tools, methods and standards.

The House version of the bill is co-sponsored by Diana DeGette (D-CO) and Erik Paulsen (R-TX). A companion piece of legislation in the Senate by the same name is sponsored by Sens. Mark Kirk (R-IL) and Barbara Boxer (D-CA).

The bill comes just as the NIH's Center for Regenerative Medicine (CRM) appears to be in disarray following the departure of its leader, Dr. Mahendra Rao. Rao was reportedly frustrated about the lack the center's lack of funding for regenerative medicine projects.


Regenerative Medicine Promotion Act (RMPA) of 2014

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