Congressman Leonard Lance (NJ-07) hailed the work of the House Energy and Commerce Committee for its unanimous approval of bipartisan legislation, the 21st Century Cures Act. Lance has long championed the fight for opening the innovation pipeline and bringing biomedical innovation to market faster and ensuring regulatory agencies and the private sector have the tools to create in the 21st century. The 21st Century Cures Act included Lance’s legislation, the FDA Safety Over Sequestration Act (FDA SOS Act), which exempts Food and Drug Administration (FDA) user fees from sequestration and puts those resources back for the approval of drugs and medical devices.
“The 21st Century Cures Initiative will make a positive difference in the lives of many and enable the FDA to perform its mission to improve the health of the United States. The vote in the Energy and Commerce Committee sends to the House Floor a major legislative package that will help usher in a new era of collaboration among researchers, patients and physicians and those who hold the key to a new generation of health care innovation. The human need is the driving force – motivating advocates and survivors to this cause. Together we bring hope to the millions with a disease or disability and those who struggle everyday with chronic and life-threatening conditions. They await the genius of new and better medicines. We took this action in their name,” said Lance, a member of the Health Subcommittee who has been involved in the years-long process.
FDA user fees are private dollars earmarked specifically for patients, public health and medical innovation. Lance has worked to protect the FDA user fees which are industry-financed and account for roughly 35 percent of the FDA’s budget. Under sequestration, the FDA is prohibited from collecting approximately more than $1 billion over a five-year period, according to the non-partisan Congressional Budget Office (CBO) – which would cripple its ability to get safe and effective drugs to the market quickly. Congress has recently increased FDA user fees in addition to strengthening and improving the review process.
Dean J. Paranicas, President and CEO of the HealthCare Institute of New Jersey, added, “21st Century Cures is vitally important to New Jersey’s life sciences community, but more importantly, to patients around the world. This landmark legislation modernizes America’s apparatus for researching, reviewing and approving new life-saving medical therapies and would accelerate the pace of discovering cures for some of the world’s most dreaded diseases. The inclusion of Congressman Lance’s legislation to exempt FDA user fees from sequestration is a victory for patients who need new, life-saving medical breakthroughs to be reviewed, approved and delivered to patients as quickly, efficiently and safely as possible. We commend Congressman Lance for his leadership on 21st Century Cures and his commitment to the patient community.”
“The 21st Century Cures Initiative is a landmark legislative package. It will change public health in this country and advance responsible policy. This effort will open the path to new medicines and medical devices that are safe and effective,” Lance concluded.