> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Senate HELP Committee Passes 7 Biomedical Innovation Bills - URL: https://www.fdaweb.com/senate-help-committee-passes-7-biomedical-innovation-bills/ - Published: 2016-02-09T12:00:00.000Z - Updated: 2026-09-15T02:34:34.000Z - Author: David McFarland - Tags: Drugs, Devices, #legacy-id-D5134710 > The Senate Health, Education, Labor and Pensions Committee 2/9 favorably voted out seven bipartisan bills on biomedical innovation. Despite the favorable votes, there remains a divide on providing FDA and NIH with funding to implement the measures. The next HELP meeting is scheduled for 3/9, where the committee will debate and vote on at least five additional bipartisan bills. > > > > > > “This is an important day, not just for this committee—but for all Americans who stand to benefit from this exciting time in medical innovation and research,” said HELP chairman **Lamar Alexander** (R-TN). “The House has completed its work on the 21st Century Cures Act, the president has announced his support for a Precision Medicine Initiative and a ‘cancer moonshot’—and with this bipartisan action in committee today, we’ve shown the Senate’s potential to be the vehicle that turns these groundbreaking ideas into law this year to help improve the lives of nearly every single American.” > > > > > > Alexander told the markup that there are 50 legislative proposals in total that the committee will evaluate. A second markup is scheduled for 3/9 and then a third on 4/6\. “My expectation is that during these three markups, we will consider all 50 of these proposals and that when we have finished in early April, they will add up to companion legislation to the House-passed 21st Century Cures legislation and will include support for the president’s initiatives in precision medicine and cancer research,” he said. > > > > > > Additional funding for NIH and FDA remains a contentious issue. The 21st Century Cures Act includes $9.3 billion in mandatory funding over five years, mostly for NIH. “I am willing to consider additional advances in support for what I would call an Innovation Projects Fund,” Alexander said. “These would be a limited number of high priority initiatives which would give the director of NIH the authority and ability to harness extraordinary opportunities... We may be able to support these initiatives in our normal appropriations process but I am willing to consider using mandatory funding for these initiatives. Because of our budget deficit, we would need to find that funding by reducing existing mandatory funding. As a practical matter, there are not bipartisan ways to pay for an innovation fund through mandatory funding in this committee’s jurisdiction. So we will deal with the Innovation Fund, and how to pay for it, when the bill comes to the floor.” > > > > > > Senator **Elizabeth Warren** (D-MA) was opposed to the process the committee leadership has undertaken. “The need for strong biomedical innovation is urgent, and we should be honest here,” she said at the markup. “A handful of smaller targeted changes like we’re voting on today won’t get us where we need to be. Democrats and Republicans have been working together for nearly a year to develop a package to strengthen the FDA and to dramatically boost funding for NIH — the twin pillars of advancing real medical innovation. I am very worried that this bigger effort is in jeopardy for two reasons. > > > > > > “First,” she continued, “some Republicans seem to want to use this discussion as an opportunity to neuter the FDA. This is not only wrong-headed, it is reckless. The goal of high FDA standards is to incentivize development of innovative products. Transformative products. Safe and effective products. Products that will cure disease, save money, and save lives. Our goal should not be to weaken the standards so that giant corporations can increase their profits by selling dangerous or useless drugs to the American people. Democrats are willing to support reasonable changes to improve the FDA. But if Republicans are determined to gut the agency under the guise of improving it, then get ready for a fight on this. > > > > > > “The second reason I’m worried,” Warren went on, “is because we do not yet have an agreement to include significant investments in research. In hearing after hearing, Democrats have called for mandatory NIH funding as part of any legislative package. Because big medical breakthroughs don’t come from tweaking the process over at FDA. Big medical breakthroughs come from increasing basic research. And that’s where we’re falling dangerously behind. Adjusted for inflation, Congress’s investment in NIH over the last dozen years has been cut by 20%.” > > > > > > Warren noted that last year Congress increased NIH’s budget by about 7% for 2016\. “That increase is a drop in the bucket compared to what’s needed to repair years of underfunding and help us remain the world leader,” she said. “Sure, heading into an election year, it would be easier to pass some small bills, call it medical innovation, declare victory, and quit. We cannot punt this to some vague promise to add funding later on. This committee can and must include mandatory funding in any innovations bill. I’m tired of pretending. Until we can get bipartisan agreement on a package to strengthen the FDA and fund NIH, I will not support any more so-called ‘innovation’ legislation in this Committee.” > > > > > > By voice votes, the following bills were passed by the committee 2/9: > > **The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S. 2030)**: A bill to help advance therapies to patients with serious or life-threatening rare genetic diseases by allowing innovators to rely on their own data used for a previously approved targeted therapies to develop subsequent targeted therapies.**The FDA Device Accountability Act of 2015 (S. 1622)**: A bill to speed new medical devices to market by reducing unnecessary burdens in device evaluations and streamlining the review process for clinical trials. Additionally, it modernizes the regulation of diagnostic tests by creating a path for rapid diagnostics.**The Next Generation Researchers Act (S. 2014)**: A bill to help attract talented young scientists to the National Institutes of Health (NIH).**The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act (S. 800)**: A bill that would update rehabilitation research for the first time in more than 20 years and require the National Center for Medical Rehabilitation Research (NCMRR) to develop and periodically update a comprehensive research plan for rehabilitation research.**The Advancing Research for Neurological Diseases Act of 2015 (S. 849)**: A bill to help advance the understanding of neurological diseases and help researchers access data on these diseases in order to discover new therapies and cures.**The Preventing Superbugs and Protecting Patients Act (S. 2503)**: Legislation to further encourage and clarify that FDA requires cleaning and validation data for reusable medical devices and to direct the agency to clarify when device changes require regulatory clearance.**The Improving Health Information Technology Act (S. 2511)**: Legislation to improve health information technology for doctors and their patients.