Congress this week began voting on a sweeping biomedical innovation bill that includes nearly $5 billion in dedicated funding for a trio of major research initiatives at the National Institutes of Health (NIH). The bill also includes measures to speed the approval of new drugs and medical devices by the Food and Drug Administration, and it would create a mechanism for catalyzing efforts to streamline federal regulations that universities and academic researchers regard as burdensome. The bipartisan bill, known as the 21st Century Cures Act, is the culmination of more than 2 years of lobbying by research, patient, and industry groups, and extensive negotiations between members of the Senate and the House of Representatives. The bill includes a long list of largely uncontroversial NIH provisions, including calls for the agency to produce a comprehensive strategic plan, set up a special initiative for young scientists, establish a prize to incentivize certain kinds of research, and take new steps to encourage data sharing and ensure the reproducibility of NIH-funded research. And research lobbyists are delighted with provisions that set aside $4.8 billion over the next 10 years for three NIH initiatives: $1.4 billion for Obama's Precision Medicine Initiative, $1.8 billion for Vice President Joe Biden's cancer moonshot, and $1.6 billion for the White House's Brain Research through Advancing Innovative Neurotechnologies Initiative. The bill also provides $30 million over 3 years for regenerative medicine research using adult stem cells. But biomedical research advocates are worried how the funding may ultimately play out, and other bureaucratic provisions they say could be burdensome.
Authors: Jocelyn Kaiser, Jeffrey Mervis, Kelly Servick