Coffman Introduces REGROW Act

Press Release

Today, U.S. Representative Mike Coffman (CO-06) introduced the Reliable and Effective Growth for Regenerative Health Options (REGROW) Act. The bill is co-sponsored by Representatives Mark Takai (D-HI) and H. Morgan Griffith (R-VA). A Senate version of the bill was also introduced by U.S. Senators Mark Kirk (R-IL), Joe Manchin (D-WV), and Susan Collins (R-ME).

"The development of regenerative medical treatments is one of the most exciting aspects of modern medicine. These products, developed from adult stem cells, show potential to fully restore or establish normal function in damaged human cells, tissues, or organs," said Coffman.

Currently, the Food and Drug Administration (FDA) oversees the development of regenerative applications based on a patchwork of regulations. The FDA simply does not have an approval process in place to best consider these new, innovative therapies. As a result, other countries, particularly Japan and the United Kingdom, are quickly outpacing the United States in the development of regenerative treatments.

The REGROW Act addresses the lack of FDA standards in the regenerative treatment field by creating standards that will lead to regulatory predictability regarding manufacturing processes and controls. The legislation also protects approval pathways under sections 351 and 361 of the Public Health Service Act, while creating a new category for regenerative treatment products.

Research has proven that regenerative medicine can treat, slow, or even cure the progression of many diseases. This is frequently done by harvesting a patient's own bone marrow. This method has been tested and appears to have great potential in the treatment of diseases like ALS, organ regeneration, and cancer.

"I think every American has lost a loved one to cancer or other deadly disease. It's devastating," continued Coffman. "That's why I have introduced this bill and have made it one of my priorities in Congress to support the kind of medical research that seeks cures to prevent these heartbreaking losses."

The bill is a bi-partisan effort.

"I'm pleased to have the support of both Republicans and Democrats on this important legislation," continued Coffman. "Fighting and defeating diseases that devastate families is not a partisan issue, it's an issue we can all support together."

"Groundbreaking new achievements in regenerative medicine therapies are reached every day, but they get stalled in the FDA approval process because the treatments are often too personal to scale up to large clinical trials. Regenerative medicine is based on specific patient needs, using a patient's own cells to grow healthy tissue to treat often fatal diseases. This bill cuts through the bureaucratic red tape to provide temporary, conditional approval if a therapy is first shown to be safe and likely to be effective. Last year, Congress was able to secure increased funding for NIH precision medicine programs, which will help develop even better personalized health technologies and expand their reach. Now, we must make sure we tailor our regulations to allow for patients access to every opportunity for lifesaving medical care as they become available," Representative Takai said.

"Regenerative medicine is another area of exciting scientific breakthrough. Accordingly, FDA needs to develop new regulatory models and pathways in order to better facilitate the approval of these therapies to give more timely access and hope to the patients that need them. This bill provides FDA with the tools and flexibility it needs to conditionally approve safe and effective regenerative medicine technologies," Representative Griffith said.

"As a stroke survivor, I know how much potential new regenerative therapies have for the thousands of other stroke survivors nationwide," Senator Kirk said. "The REGROW Act provides clarity for companies and doctors who are developing breakthrough products and helping their patients. By expanding options for those living with Alzheimer's, Parkinson's, diabetes and stroke, we can help more patients live the life they want on their own terms."

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