21st Century Cures passes in Senate vote
The US Senate has passed the 21st Century Cures Act, a series of extensive medical funding reforms, in a 94-5 vote on Wednesday. The vote marks a final legislative triumph for outgoing President Barack Obama, who strongly supported the bill in the face of opposition from some senior Democrats.
21st Century Cures aims to create a framework for faster approval on medical devices and prescription drugs. As well as accelerating the drug development process, the Cures Act would give $1 billion to tackle the opioid crisis, plus $4.8 billion for continuing three key Obama administration research programs over the next three years – the Cancer Moonshot, the Precision Medicine Initiative, and the BRAIN Initiative.
In a statement released after the passage of the bill, the President said, “We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need. The bipartisan passage of the 21st Century Cures Act is an example of the progress we can make when people from both parties work together to improve the health of our families, friends and neighbors.”
Among those voting ‘no’ for the Cures Act in the Senate were Sen. Elizabeth Warren, who described the bill as “extortion”, arguing that it had been “hijacked” by pharma. Democrat colleague Bernie Sanders also refused to support the act, describing it as a “bad bill” that should not be allowed to pass in its current form.
However, Sen. Warren has left her mark on the Act in the form of strengthened privacy protections for genetic research participants, which guard against misuse of the Freedom of Information Act to gain access to participants’ genetic and health information.
In a statement in support of the protections, Hal Dietz, MD, President of the American Society of Human Genetics said “With improved protections, individuals can participate in research with increased confidence that their genetic and health information will remain private. The Society applauds the leadership of Senator Warren and Senator Enzi in establishing these protections.”
On the side of 21st Century Cures was Representative Tim Murphy (R-Penn.), who pushed for provisions that will fund care programmes for mental health.
“To all the families who brought their stories out of the shadows, that dared to share their sorrows, their hopes, their shattered dreams, today is a day of joy,” said Murphy, who is a psychologist. “And today is only possible, I say to all those families, because they dared to step forward.”
The Pancreatic Cancer Action Network have also endorsed the passage of the bill, saying it will provide “critical funding for the Cancer Moonshot initiative.”
“The 21st Century Cures Act will help ensure that this important work on immunotherapy, personalized medicine and other vital research opportunities will move forward quickly to benefit patients,” said Megan Gordon Don, vice president of Government Affairs and Advocacy at the Pancreatic Cancer Action Network. “We urge President Obama to enact the legislation without delay and urge Congress to ensure that the authorized funds are included in the FY 2017 Continuing Resolution.”
Last week, the House of Representatives passed the Act by 392 votes to 26, in a rare display of bipartisan comradeship from Republicans and Democrats. Proponents include patient advocacy groups frustrated by the current slow speed of regulatory processes, while detractors argue that speeding up the approval process could compromise safety standards and weaken regulation on medical devices.