This December, President Obama and the U.S Congress made history by passing the 21st Century Cures Act, a piece of legislation that has enormous implications for the field of regenerative medicine. Now that it has officially become law, this massive piece of legislation will have far reaching impacts on numerous components of medical research, product development, and health care delivery.
The New Regenerative Advanced Therapy
The 21st Century Cures Act provides an option for regenerative medicine products be categorized as “regenerative advanced therapy.” If designated as such, a product becomes eligible for priority review by the FDA. This is a huge step of progress for stem cell advocates who are eager to use their treatments on patients and have been held back from doing so by the “red tape” of the system.
By definition, regenerative advanced therapy is considered to be a product aimed at treating or curing a serious disease, especially with the potential to provide currently unmet medical needs. In addition, the product must fall under the Act’s definition of “cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products.” Since the majority of regenerative medicine products in development meet these standards, anything currently in stages of development to help resolve serious conditions like paralysis, MS, dementia, and so much more could be soon available to patients in desperate need.
Wide Ranging Benefits
Those who use stem cells in medical applications know exactly how powerful they are to overcome previously incurable conditions, and the level of excitement over stem cell potential is limitless. This makes the 21st Century Cures Act all the more important because of how accessible it will make regenerative medicine to the public. The number, length, and complexity of clinical trials will be reduced because the FDA will allow sponsors to conduct confirmatory clinical trials after the product or technology becomes available on the market. This means that patients can receive life-changing treatments sooner, and the companies are still held liable for their promises because they can have their accelerated approval withdrawn if their products do not achieve expected responses.
For anybody living with a condition that has a promising stem cell treatment in the works, the 21st Century Cures Act will prove truly life altering.