It’s been more than a year since the House passed the 21st Century Cures Act, which aims to speed up regulatory approval for medical devices and drugs, but the Senate’s chief advocate for the legislation said it’ll be at least another seven weeks before its put up for a vote.
The House version of the legislation provided an additional $9.3 billion in funding to the National Institutes of Health (NIH), established a Cures Innovation Fund to support biomedical research and gave the Food and Drug Administration (FDA) an additional $500 million. It would also direct the FDA to develop criteria to rely on evidence outside of randomized, controlled trials when testing new uses for existing drugs, and allow devices to be approved through smaller, shorter trials—both ideas some physicians said could lead to unsafe devices and drugs harming patients.
The bill easily passed the House in July 2015 by a vote of 344-77, but the Senate instead chose to pass elements of the House package separately. While 19 bills have cleared committee, Sen. Lamar Alexander, R-Tenn., chairman of the Senate’s health committee, said disagreements over funding mean a final compromise will have to wait until after Labor Day, lawmakers return from an unusually long seven-week recess.
“Rarely do we have such an opportunity: It includes support for the President’s Precision Medicine initiative and the Vice President’s Cancer Moonshot. Speaker Ryan has said that 21st Century Cures is a major part of his healthcare agenda. Majority Leader McConnell says he wants to pass the bill this year,” Alexander said. “This could be the most important legislation Congress passes this year, and there’s no excuse for not finishing our work in September.”
The sticking point is what form the funding will take. The ranking Democrat on the health committee, Washington Sen. Patty Murray, has called for it to be “mandatory” fundings, which wouldn’t be subject to spending limits. Republicans favor finding offsetting cuts elsewhere within HHS.
The argument is similar to other health bill funding fights where Democrats and Republicans where have failed to reach agreements, including funding to address opioid abuse and the Zika virus.
The delay doesn’t mean the bill is dead, though advocates for its passage are concerned that the legislation may eventually be pushed off until the next Congress is seated.
“I think the odds have always been tough. I think that they are steeper now," Ellie Dehoney, vice president of policy for research advocacy group Research! America, said to the Washington Examiner. "But never say never.”
Not everyone believes the delay is a bad thing. Writing in Health Affairs, Tracy Rupp, PharmD, MPH, and Paul Brown of the National Institutes of Health Research, along with consumer advocate Steven Findlay, argued the legislation’s “premise is faulty,” and advocated for the next Congress to separate the extra funding from what they see as troubling changes to the FDA’s approval standards.
“The legislation, while containing some useful measures, is flawed,” the three wrote. "Instead of hastily agreeing to it, Congress should postpone consideration until 2017 and attach the best of the 19 bills to must-pass legislation on FDA funding through industry user fees. At that time, we believe the Senate should reject those bills that lower standards for drug and device approvals and safety and risk adding to the rising cost of prescription drugs.”