21st Century Cures Act Signed by President Obama

Daniel Hayes, MD

Daniel Hayes, MD

President Barack Obama has signed the 21st Century Cures Act into law, earmarking $6.3 billion over 10 years to go toward advancements in precision medicine development, brain research, heroin and prescription drug abuse prevention, and mental health.

Two years in the making, the legislation includes $1.8 billion for Vice President Joe Biden’s Cancer Moonshot program, now renamed for his son, Beau Biden, who died of a brain tumor last year. "I believe that the United States of America should be the country that ends cancer once and for all,” Obama said.

The breakdown includes $1 billion for fighting the opioid epidemic; $1.5 billion for the BRAIN Initiative to find new ways to treat, cure and prevent brain disorders such as Alzheimer’s and epilepsy; $1.5 billion over 10 years for the Precision Medicine Initiative; and $500 million to the FDA over 10 years to speed up drug approvals and access to medical devices for patients. It also includes bipartisan mental health reforms.

“The Cures Act brings us one step closer to breakthroughs on some of the biggest health challenges of our time,” Obama added.

Obama and Biden stressed the bipartisan cooperation that led to the overwhelming House and Senate votes to approve in the past two weeks.

Biden said, “This is going to give hope. Every day, millions are praying—praying for hope, praying for time. This will accelerate the kinds of efforts we can make right now, to extend life.”

Although the White House praised the Cures Act, it has also been criticized for potentially weakening the FDA’s ability to scrutinize new drug applications and regulate medical devices. The bill includes provisions that would reduce the amount of data drug developers must supply the FDA for purposes of drug review. Patient advocacy groups, eager to speed up the development and marketing of life-saving medicines, and a battalion of pharmaceutical industry lobbyists argued for passage of the bill.

Obama has stated that the legislative package represents a compromise that will lead to essential advances in medicine and social health conditions.

The brain initiative, he said, would “revolutionize” understanding of Alzheimer’s, traumatic brain injury, and epilepsy. The precision medicine component would improve the targeting of drugs, and the mental health element would ensure that insurance companies treat substance abuse disorders fairly, while improving the screening of potential inmates to determine whether mental illness treatment would be better for them than incarceration. The act includes provisions for improvement of clinical trials.

ASCO President Daniel Hayes, MD, has praised the Cures Act as “landmark legislation [that] will spur development and delivery of promising new treatments for patients.”