Republican and Democratic senators continued their clash Wednesday over how to promote and fund biomedical research and innovations even as they approved six legislative pieces in a broader package they are considering as companion legislation to the House-passed 21st Century Cures Act.
The House overwhelmingly approved the Cures Act last July. It included nearly $9 billion in increased funding over the next five years for the National Institutes of Health.
Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, decided to consider the issues addressed in the House bill in a piecemeal way through more than 20 individual bills.
Wednesday was the second markup for the Senate bills. Seven were approved last month amid a funding disagreement that carried over to Wednesday's hearing. Democrats want funding increases to the NIH to be locked in, while Republicans have balked at agreeing to that.
The fate of this biomedical innovation legislation remains up in the air, though it's one of the few major legislative initiatives thought to have a chance during the bitterly contested 2016 presidential and congressional election campaigns.
Sen. Elizabeth Warren (D-Mass.) offered an amendment that would create a Biomedical Innovation Fund that provides $5 billion a year for the next 10 years to certain NIH and Food and Drug Administration initiatives, on top of their existing budget allocations. Warren said that without a dedicated source of funding, no biomedical innovation bill will make it out of the Senate.
Delay “is literally killing people,” she said. “We need real medical innovation and that starts with funding basic medical research.”
Alexander said mandatory funding could be used to create an innovation projects fund to provide a surge of funding for specific priority projects. He did not provide a funding amount he would consider.
The Tennessee senator said the package of bills being considered could be some of the most important legislation of the year if it is adopted. “We have the House and the president (PDF) on the same track with this, which doesn't always happen,” he said, in a bit of an understatement.
Alexander said he sees no other way of financing President Barack Obama's Precision Medicine Initiative or the cancer “moonshot” research efforts being led by Vice President Joe Biden.
The bills considered Wednesday would expand the FDA's priority review abilities and would require drug companies to provide more information about patient engagement.
Sen. Patty Murray (D-Wash.) introduced another amendment to create a medical-device surveillance program in the FDA to monitor the safety of devices already on the market.
Warren and Murray withdrew their respective amendments so as to avoid forcing an immediate vote on the issues.
The markup for the next set of Senate bills is scheduled for April 6.