The U.S. Senate cleared the way for the 21st Century Cures Act, an omnibus healthcare spending and reform bill, by voting 85-13 to end debate this evening.
It passed the House with 392 votes last week. After a final Senate vote as early as tomorrow, it will head to President Obama’s desk.
The president used his national weekly address to rally support, as well, highlighting the Act’s funding to address the opioid crisis and to sustain ambitious national biomedical research projects that his administration launched. The bill calls for $4.8 billion to the National Institutes of Health for cancer, neuroscience, and precision medicine studies, $1 billion to distribute as state grants for opioid addiction treatment and prevention, and $500 million for the FDA to spend on unspecified “innovation” programs.
The Senate honored Vice President Joe Biden during today’s session by renaming part of the bill after his son, Beau Biden, whose death from brain cancer in 2015 underscored his father’s efforts to create the national “cancer moonshot” program. An emotional Biden presided over the session.
Despite the emotion and bipartisan work to pass the Cures Act, major questions remain about its funding, which the bill says must come in large part from an existing public health fund that was created by the Affordable Care Act. If the ACA is repealed, as President-elect Donald Trump and Congressional Republicans have vowed to do as quickly as possible, it is unclear if that funding would continue.
In the Senate, critics like Bernie Sanders (I-VT) and Elizabeth Warren (D-MA) have said the bill’s loosening of FDA standards, or promises of faster reviews, were crafted to benefit drug and device makers, not patients.
Some of the reforms in the bill require FDA to accept more patient input and include real-world data—from daily medical practice, not just from clinical trials—as part of its evaluation of products. The FDA has spoken cautiously about making those changes in the past. At a meeting in June, Commissioner Rob Califf told the audience that higher quality real-world data could one day be used to bolster clinical evidence. Drug approvals will always be driven by the quality of the science behind the R&D, he said, but “as the data environment changes, the regulatory environment will change.”
The Cures Act attracted the official attention of 1,455 lobbyists on all sides, making it one of the most lobbied bills of the 114th Congress, according to analysis of disclosure records by Kaiser Health News.