President Obama Signs 21st Century Cures Act Into Law
By Jof Enriquez,
Follow me on Twitter @jofenriq
U.S. President Barack Obama has formally signed the 21st Century Cures Act into law, which heralds sweeping changes to drug and medical device regulation, mental healthcare, biomedical research, and initiates several ambitious medical programs, including a "cancer moonshot" and a precision medicine initiative.
"We are bringing to reality the possibility of new breakthroughs to some of the greatest health-care challenges of our time, said Obama, reports the Washington Post. “It is wonderful to see how well Democrats and Republicans in the closing day of this Congress came together around a common cause. And I think it indicates the power of this issue and how deeply it touches every family across America."
The Cures law overcame two years of debate and revisions in Congress to become the most important piece of healthcare legislation since the Affordable Care Act (ACA), or Obamacare, in 2010. Unusual bipartisan support led the swift passage of the legislation in the House and Senate earlier this month.
"I’m confident that it will lead to better years and better lives for millions of Americans, the work that you’ve done. That’s what we got sent here for. And it’s not always what we do. It’s a good day to see us doing our jobs," Obama said at the public ceremonial signing, held at the White House's South Court Auditorium.
The legislation earmarks $6.3 billion in overall funding over the next decade. This includes $1 billion to be given to states for tackling the opioid epidemic by improving access to addiction treatment.
The National Institutes of Health (NIH) will receive $4.8 billion to shore up its research efforts, including $1.8 billion for Vice President Joe Biden's Cancer Moonshot, and separately, Obama’s Precision Medicine initiative and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative.
In a statement published in the New England Journal of Medicine (NEJM), NIH said, "Congress has provided an enormous gift to science in the form of the Cures Act, a gift that reflects a deep confidence in the promise of biomedical research to make discoveries and develop cures in the 21st century."
NIH also praised the Cures law for cutting red-tape by eliminating Paperwork Reduction Act requirements for NIH research, promoting rapid data sharing among scientists, and supporting younger and early-stage researchers.
Cures also gives $500 million to the Food and Drug Administration (FDA) to streamline clinical trials for drugs and devices, and incorporating real-world evidence (RWE) in regulatory decision-making. FDA officials last week said that randomized trials need not necessarily be incompatible with RWE. The comments were in response to criticism that RWE lacks scientific rigor for vetting unsafe products.
FDA Commissioner Robert Califf reiterated the value of RWE in a recent blog post, "In fact, the use of randomization within the context of clinical practice will constitute a major advance in evidence generation and we are actively encouraging proposals with this combination of randomized trials conducted in real world practice. Cures provides support for continued exploration of the use of real world evidence in the regulatory context."
Rather than disregarding patient safety, Califf said that Cures "recognizes that patients should play an essential role in the development of drugs and devices to diagnose and treat their disease" and that FDA's ongoing initiatives to evaluate patient input will only strengthen with the passage of the law.
Califf also said that Cures builds on FDA’s expedited access pathway (EAP) program – which so far has accepted 24 devices during its first year of implementation – by creating a breakthrough device pathway to expedite patients' access to novel medical devices.