On December 13, President Obama signed into law H.R. 34, the 21st Century Cures Act, a bipartisan piece of legislation Congress had been negotiating since the original bill passed the U.S. House of Representatives in July 2015. The bill affects primarily the Food and Drug Administration and the National Institutes of Health (NIH) and includes provisions intended to improve mental health, building on recommendations from the President’s Mental Health and Substance Use Disorder Parity Task Force. The bill also funds the states’ efforts to fight the ongoing opioid epidemic.
With respect to the NIH, the bill provides $4.8 billion over ten years, including $1.8 billion for the Cancer Moonshot initiative; $1.5 billion for the ongoing Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative; $1.5 billion for the president’s Precision Medicine Initiative; and, $30 million for adult stem cell research. The bill also includes $1 billion over two years for grants to the states to the fight the opioid epidemic.
The funding will flow from sales of the strategic petroleum fund reserves and cuts to the Public Health and Prevention Fund; however, the House and Senate Appropriations Committees will be required to review and release the funds on an annual basis. Every year, NIH must submit a “work plan” to the NIH oversight committees in Congress, detailing how the agency is allocating the funds across these four projects. The plan must link to objectives in the agency’s strategic plan.
The bill also includes a proposal to create the “Next Generation of Researchers Initiative” in the NIH Office of the Director to improve opportunities for new researchers and a section aimed at reducing administrative burdens for researchers. It specifies that Institute and Center directors may serve five-year terms and be reappointed at the end of their term without any limits on the number of terms they can serve.
On the mental health front, the law includes a number of administrative reforms. These include sections designating the Administrator of the Substance Abuse and Mental Health Services Administration as the Assistant Secretary for Mental Health and Substance Use, establishing a Interdepartmental Serious Mental Illness Coordinating Committee to coordinate mental health services for adults and children, and authorizing Centers for Mental Health Services, Substance Abuse Prevention, and Substance Abuse Treatment.
A comprehensive summary of the bill is posted on the House Energy and Commerce Committee home page.