President Obama Enacts the 21st Century Cures Act, Institutionalizing Cancer Moonshot, Precision Medicine, and BRAIN Initiatives into Law

For outgoing 55-year-old President Barack Obama, it was an unusual day. On December 13, surrounded by Vice President Biden and key lawmakers, he finally signed the 21st Century Cures Act into law at the White House, thereby enacting its provisions into law.

This biomedical innovation bill aims to curb drug abuse, deepen understanding of diseases such as dementia and cancer, and accelerate the research, development, and approval processes for new drugs. It previously received unanimous bipartisan support in the U.S. Congress, passing the Senate with 94 votes in favor and 5 against, and the House of Representatives with 329 votes in favor and 26 against. The nearly 1,000-page legislation was thus enacted.

The 21st Century Cures Act invested $1.8 billion in the Cancer “Moonshot” Initiative, which received strong support from Vice President Biden, whose son Beau died of brain cancer in 2015. Biden stated, “This legislation will inject a new sense of urgency into the fight against cancer and enable millions of Americans to benefit from research-driven advances in treatment and improved quality of life.”See VCBeat’s previous report: Pharmaceutical companies emerge as major winners of the U.S. 21st Century Cures Act, potentially accelerating new drug approvals for new indications.

The legislation will also allocate $1 billion over the next two years to combat the misuse of prescription opioids and other addictive substances, such as heroin. Additionally, the bill will invest $3 billion in President Obama’s “BRAIN Initiative” ($1.56 billion) and “Precision Medicine” initiative ($1.4 billion), advancing research into diseases such as Alzheimer’s.

The bill also streamlines the FDA approval process for drugs and medical devices. For instance, when evaluating approvals for existing drugs repurposed for new indications, reliance must be placed on data summaries and “real-world evidence” rather than robust clinical trial evidence. The FDA is now required to consider “patient experience” and prior condition data during its review process. Approval processes will be accelerated for breakthrough medical technologies.

Notably, the 21st Century Cures Act will take measures to improve the mental health of Americans by establishing a new position within the U.S. Department of Health and Human Services to coordinate research and treatment for mental health and substance abuse.

Overall, the initiative plans to invest $6.3 billion over the next decade. Obama stated, “Many Americans have felt the grief of losing loved ones to cancer, mental illness, and other conditions addressed in the legislation, much like my own mother, who passed away in her fifties from cancer.”

According to The New York Times, the law authorizes the NIH to fund high-risk, high-reward research without going through conventional grants and contracts. The agency will also establish the “Eureka Prize” to advance medical research.