The House of Representatives has approved the bipartisan 21st Century Cures legislation, which includes funding for innovative biomedical research and provisions to speed up the drug approval process.
The House of Representatives has approved the bipartisan 21st Century Cures legislation, which includes funding for innovative research and provisions to speed up the drug approval process.
By a vote of 392-26, the House approved the 21st Century Cures Act. The House had passed an earlier version of the bill in July 2015 but continued to revise and update it, releasing the most recent draft of the bill last week. These updates included provisions for mental health, substance abuse, and child and family services.
Members of both political parties have been vocal in their support of the legislation, often citing its passage as a top priority during the lame-duck Congressional session. Prior to the election, Senate Majority Leader Mitch McConnell, R-Kentucky, had said it “could end up being the most significant piece of legislation we pass in the whole Congress."
The bill will provide the National Institutes of Health with $4.8 billion, in part to ensure the continued funding of the BRAIN Initiative, President Barack Obama’s Precision Medicine Initiative and Vice President Joe Biden’s Cancer Moonshot over the next 10 years. It also supports prevention, treatment, and recovery programs for substance abuse and mental health disorders, including $1 billion in state grants to fight opioid abuse.
The Academy of Managed Care Pharmacy's CEO called the passage of the bill a crucial step as US healthcare moves from a fee-for-service system to a value-based one.
“The Academy commends the House for its overwhelming passage of this important bipartisan legislation," Susan A. Cantrell, RPh, CAE, said in a statement. "There are provisions of this bill that we strongly support, and will result in improvements to the health of our citizens, from prompting new cures for cancer to combating opioid addiction, and much more."
The bill’s passage in the House occurred despite controversy surrounding some components of the legislation that concerned the FDA’s drug approval process. To speed up this process, one provision would allow the use of “real-world evidence” instead of the more time-consuming clinical trials currently required to demonstrate efficacy.
While pharmaceutical companies are eagerly anticipating these faster processes, patient advocates worry that safety will be sacrificed in the rush to push drugs to the markets. Before the House voted to approve the bill, Senator Elizabeth Warren, D-Massachusetts, said the legislation had been “hijacked” by the pharmaceutical industry and vowed to fight it if it reached the Senate.
Nonetheless, the bill is expected to pass in the Senate next week, allowing Obama to sign it into law by the end of the year.
“21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need," Energy and Commerce Committee Chairman Fred Upton, R-Michigan, and Representative Diana DeGette, D-Colorado, co-authors of the bill, said in a statement. "The White House has expressed its enthusiastic endorsement of this critical legislation. So it’s now on to the Senate, where we are just one final vote away from delivering #CuresNow.”