{mosads}The measure passed 94-5, with liberals like Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) opposing it over provisions on drugmaker incentives.
The bill has been trumpeted by leaders from both sides of the aisle for its focus on life-saving research, including nearly $2 billion for Vice President Biden’s cancer “moonshot” initiative. President Obama is expected to sign the measure quickly.
“This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk,” Obama wrote in a statement shortly after the passage.
Obama said the bill puts the nation “one step closer” to ending cancer, treating diseases like Alzheimer’s and expanding access to drug addiction treatment.
The 21st Century Cures Act marks the first time Congress has approved funding to address the nation’s growing opioid epidemic, authorizing $1 billion in state grants.
It also makes the biggest changes to the nation’s mental health system in more than a decade. Those reforms are the result of the GOP’s behind-the-scenes efforts to tackle gun violence, which began after the 2012 Sandy Hook Elementary School shooting in Newtown, Conn.
Sen. Lamar Alexander (R-Tenn.), who has shepherded the bill through the upper chamber over the last year, called it a “Christmas miracle.”
He said the broad scope of the bill reflected a rare moment of compromise within Congress and in the White House to tackle some of the nation’s top concerns — difficult-to-treat diseases, opioid addiction and mental health.
Alexander, who leads the Senate Health Committee, pointed to the “unusual” work across the aisles. Biden made personal phone calls urging senators to pass the bill, while Speaker Paul Ryan (R-Wis.) did a “triple somersault” to find a way to fund the bill, he said.
The final bill is an ambitious mix of regulatory reform and a new research push for hard-to-treat diseases.
It speeds up approval for “breakthrough” medical devices, reforms the government’s rules for clinical trials and creates new incentives for drug companies to study rare diseases. It also puts a greater focus on patient data to move toward “personalized medicine,” a priority of President Obama’s health team.
Out of the $4.8 billion allocated to the National Institutes of Health, about $1.6 billion will go toward brain studies that could help treat diseases like Alzheimer’s. Another $1.4 billion will go toward Obama’s “precision medicine” initiative.
The Food and Drug Administration (FDA), which many medical advocates describe as chronically underfunded, would receive about $500 million to help with its new responsibilities.
The bill had a long and difficult path to final passage, with input from every corner of the healthcare sector. A total of 1,455 lobbyists representing 400 companies, universities and other groups gave input on the bill, according to the Center for Responsive Politics.
Even with near-unanimous support in both chambers, some groups remained opposed to the bill.
The National Center for Health Research has warned against speeding up the approval of certain drugs, which it said would risk patient safety. The Trust for America’s Health blasted the GOP’s decision to offset some of the new medical funding through the prevention and public health fund, which was created under ObamaCare.
Heritage Action, a conservative group, blasted the bill’s funding as a “gimmick” and called it a “Christmas tree” for health legislation.
Progressive opponents like Warren have called the bill “extortion” and said it was “hijacked” by drug companies.
The sprawling legislation began as a 400-page draft bill that Republicans wrote in January 2015, without input from Democrats.
House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) launched a full-scale campaign with Rep. Diana DeGette (D-Colo.) to get the legislation across the finish line.
Together, Upton and Degette began whittling away some of the more controversial attempts to cut back on rules for drugmakers, upping the focus on medical research.
The House passed two different versions of the bill over nearly two years. That process included numerous internal spats, abruptly delayed markups and a late attempt to jump-start the bill this September.
In the Senate, the bill faced an uphill slog even after it cleared the House with near-unanimous consent. The big funding questions prompted Alexander and his committee to break up the House’s package into 19 separate bills.
Lawmakers spent months wrestling with questions like how quickly the FDA could approve new treatments and devices and what kinds of incentives drugmakers should receive to focus on rare diseases.
“It still wasn’t easy to pass, because we’re dealing with a lot of life and death issues,” Alexander said on the floor Wednesday.