A Senate committee on Tuesday moved forward with several bills that are a part of companion legislation to the House's 21st Century Cures Act, but lawmakers disagreed about mandatory funding for federal health agencies.
The House passed the healthcare innovation bill by a wide margin in July. It includes more than $8 billion in mandatory funding for the National Institutes of Health. The Senate has struggled with companion legislation mostly because there isn't a plan for how to pay for the bill.
Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, last month said his panel would take a piecemeal approach by marking up batches of smaller bills in the coming months. The first hearing of seven bills was Tuesday and all were approved. They range from expediting therapies for rare diseases to improving electronic health records.
The committee will have markups on the rest of the bills that were formerly part of the Senate version of 21st Century Cures in March and April and then take them to the floor. The legislation would also likely support President Barack Obama's precision medicine initiative as well as his more recently announced project to research cancer treatment, Alexander said.
Most of the argument during the hearing Tuesday revolved around whether mandatory NIH funding should be included in any innovation bill.
Sen. Elizabeth Warren (D-Mass.) said the NIH will fall dangerously behind in research without mandatory funding. The need for biomedical innovation is urgent, but she worries that Republicans will use legislation to “neuter the FDA” instead of strengthen it, she said.
The issue should be addressed in committee and not postponed until floor discussion, Warren said. A recent boost to NIH funding in the omnibus budget agreement is not enough to make up for years of declining investment, she said.
“Real innovation starts with basic research,” Warren said.
Sen. Richard Burr (R-N.C.) said he agreed on mandatory funding but was not confident that enough of the committee would approve.
“There's not going to be an innovation bill,” he said. “I plan to write one, but I don't think it's going to make it out of this committee.”
Sen. Bill Cassidy (R-La.) said he would not support mandatory funding unless the NIH was also forced to restructure its budget as the Institute of Medicine recommended more than 20 years ago.
Alexander acknowledged that the issue is controversial but tried to keep it from derailing potential progress.
“There's no reason for that to stop our advance step by step,” he said.
The bills approved by committee Tuesday include the Advanced Targeting Therapies for Rare Diseases Act of 2015, which would allow companies creating specific therapies for serious genetic diseases to more quickly develop treatments for patients who have the same disease but with a different genetic mutation. It would give the Food and Drug Administration the authority to allow the companies to use their own data for the approval process.
Another bill that passed committee was the FDA Device Accountability Act of 2015, which gives the FDA more direction on imposing the least burdensome requirements for evaluating devices. It also allows devices to be approved by a non-local institutional review board.
