The 21st Century Cures Act
Advocates and opposition of the 21st Century Cures Act alike waited with bated breath throughout December to learn if President Obama would approve the act into a law before the New Year, and as of December 15 he did. This massive piece of legislation will have far reaching impacts on numerous components of medical research, product development, and health care delivery. It is an especially important law for regenerative medicine experts and patients alike, given its goal of accelerating the time it takes new regenerative medicine techniques and devices to enter the market. Many have lauded the 21st Century Cures Act as an important victory for patients and doctors, though it certainly isn’t without its opposition.
A New Category is Born: Regenerative Advanced Therapy
One of the most important aspects of the 21st Century Cures Act for regenerative medicine advocates is the new option for regenerative medicine products be categorized as “regenerative advanced therapy,” If designated as such, the products become eligible for priority review by the FDA. Regenerative advanced therapy is considered 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 it seems that the majority of regenerative medicine products in development meet these standards, the 21st Century Cures Act offers an exciting opportunity for regenerative medicine to skip over time consuming roadblocks on the path to meet patient needs. 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, and this is a huge step of progress in the medical world.
Wide Ranging Benefits
The implications of more accessible regenerative medicine treatments are impressive. First, the number, length, and complexity of clinical trials would be reduced because the FDA would 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sooner, and the companies are still held liable for their promises because they can have their accelerated approval withdrawn if their products do not achieve expected responses.
Furthermore, as observed by FDA Commissioner Robert Califf, the Act will create “a research network and a public-private partnership to assist developers in generating definitive evidence about whether their proposed therapies indeed provide clinical benefits that are hoped for.”
Overall, assuming that the FDA leadership requires compelling and high-quality scientific evidence before providing accelerated approval, patients with debilitating conditions will have a realistic chance of obtaining revolutionary regenerative medicine treatments to change their lives forever.
Image credit: Wikimedia Commons
