There are certainly some mixed opinions about the 21st Century Cures Act, but overall the consensus is clear.
It is great progress that the U.S. is getting behind the development of innovative regenerative medicines, including cell therapy, with the passing of the 21st Century Cures Act.
The bill, passed by both houses of Congress and signed into law today by President Obama, puts the U.S. on the same playing field as many other developed countries including those in the European Union (EU) and Japan, which already have accelerated regulatory pathways for regenerative therapies. The initiative will support President Obama’s cancer “moonshot,” Alzheimer’s research, and efforts to address opioid addiction.
The bill encourages late-stage development in regenerative medicine, recognizing the field’s potential to address severe unmet medical needs. It also correctly identifies regenerative therapy as a category in its own right.
According to Yaron Ramati, Pluristem’s Regulatory Affairs Director, the proposed FDA oversight of this therapeutic field should ensure high standards for quality and safety, facilitate early patient access to therapies with proven efficacy, and address serious and life-threatening conditions. Pluristem Therapeutics is, to the best of my knowledge, the only company in the world to have a program selected for advanced regulatory pathways in both Europe and Japan, which is why their perspective on the 21st Century Cures Act is valuable.
Purpose of the 21st Century Cures Act
The purpose of the 21st Century Cures Act is clear: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
As part of the bill, substantial support would be provided to the U.S. NIH, including the establishment of a NIH and Cures Innovation Fund, which will appropriate funds:
(1) for biomedical research, including high-risk, high-reward research and research conducted by early stage investigators;
(2) to develop and implement a strategic plan for biomedical research; and
(3) to carry out specified provisions of the Act.
The act will also authorize up to $500M for the U.S. FDA to assist with regulatory support.
Concerns over the bill surround the involvement of private industry, with 400+ companies lobbying for it, including 58 pharmaceutical companies, 26 biotechnology companies, and 24 medical device companies (data courtesy of Shelly Ross, Cure Alliance.) A rare opponent to the bill, Senator Bernie Sanders also suggested that it does not do enough to “curtail” the high costs of prescription drugs.
Nonetheless, the 21st Century Cure Act is a powerful step forward, and one that is largely supported by all but the most conservative within the scientific and medical communities. Those that oppose it are outnumbered and those that support it are realistic in assessing that it is a “step forward” and not panacea to all healthcare related concerns.
Click here to view the full 21st Century Cures Act.
Positioning America as a Global Player in Regenerative Medicine
Perhaps the greatest significance of the bill is its ability to position the U.S. as a force for regenerative medicine, alongside Japan and the European Union (EU). In particular, Japan has accelerated its position as a hub for regenerative medicine research, largely driven by support from Prime Minister Shinzo Abe who has identified regenerative medicine and cellular therapy as key to the Japan’s strategy to drive economic growth. His strategic plan also authorizes approximately ¥110 ($1 billion) in funding for stem cell research within Japan.
Japan’s Accelerated Pathway for Regenerative Medicine took effect on November 2014, under which regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and initial proof of efficacy. Safety and effectiveness then needs to be confirmed within seven years of conditional approval. The importance of this law is that it allows companies a quicker, more efficient path to commercialization.
Today, the 21st Century Cures Act positions the United States to better compete within the global marketplace for the development of novel regenerative medicine products and therapies.
President Obama Signs 21st Century Cures Act Into Law
This afternoon, President Obama signed the 21st Century Cures Act into law, authorizing $6.3 billion in funding. In an emotional signing that is likely to be the last of his presidency, President Obama stated, “Let’s make American the country to solve cancer.”
Previously, the bill was approved 392-26 by the House of Representatives and 94-5 in the U.S. Senate.
To understand the power and scope of the bill, watch the video below, as President Obama signs it into law.
As stated by Matthew Feshbach, CEO and Co-Founder of Okyanos, “We are pleased to see the passage of the REGROW Act. Rationalizing the pathway to FDA approval of adult stem products is good for everybody – patients, families and the society.”
Have thoughts, perspectives, or opinions on the Act? Share them in the comments below. This historical moment undoubtedly merits discussion.