Supporters of a major bill designed to speed up the approval of new drugs and funnel billions into cancer and brain research were confident it would pass the Senate.
Members of the U.S. House of Representatives recently approved the 21st Century Cures Act -- which provides over $6 billion for research, $500 million to the FDA, and grants for the prevention and treatment of opioid abuse -- by an overwhelming majority, 392-26.
Some Democrats in the Senate, including Sens. Elizabeth Warren, Dick Durbin and Bernie Sanders, opposed the passage of the bill, arguing that fast-tracking new drugs is a win for pharmaceutical companies, and could compromise patient safety.
But Senate Minority Leader Harry Reid expected it would pass, even if accompanied by some “angst” among Democrats.
The bill was originally introduced in July 2015; it passed the House but failed in the Senate.
After that, changes were made to “help families suffering from mental illnesses and substance abuse and to provide grants to communities for the prevention and treatment of opioid abuse,” according to U.S. Rep. Randy Hultgren (R-IL), one of the co-sponsors of the original bill.
“Since I became a member of Congress, I have expressed an interest in working with my colleagues to do more to accelerate the discovery, development and delivery of new cures for patients,” Hultgren recently told Patient Daily. “I support this legislation's emphasis on engaging patients in the FDA's drug approval process, establishing public-private partnerships to support researchers, and streamlining the agency regulatory process.”
Hultgren was confident the bill would pass the Senate, especially considering the minimal opposition.
The 21st Century Cures Act provides $4.8 billion in funding for the National Institutes of Health for the Precision Medicine Initiative, brain research and cancer research.
It also provides $500 million in funding for the Food and Drug Administration to support drug review and get new treatments and medical devices to patients more quickly -- as well as $1 billion in grants for the prevention and treatment of opioid abuse.
Hultgren described the recently approved version of the bill as “more comprehensive” because it also includes provisions to help families suffering from mental illnesses.
“This more robust version of the 21st Century Cures Act passed the House on Nov. 30,” Hultgren said. “I am very optimistic that we will see this legislation become law, and patients across the county will have expanded access to new and innovative treatments and, one day, cures.”
While some warmly welcome the bill’s passage, concerns remain, particularly related to the fast-tracking of drug and medical device approval.
Dr. Michael Carome, director at Public Citizen’s Health Research Group, told health website StatNews he was especially concerned about Cures Act provisions, which will allow the FDA to consider “real world evidence” when approving drugs. On top of that, it will allow companies to submit summaries of study data, rather than full clinical trial records.
“The summary data could hide important information about the safety and effectiveness from the FDA scientist reviewing the data,” Carome said. “I’m disappointed to see it.’’
