Cramer: House Committee Passes 21st Century Cures Act
WASHINGTON, D.C. – Recently, Congressman Kevin Cramer joined a bi-partisan majority of the U.S. House of Representatives Energy and Commerce Committee to pass 21st Century Cures by a vote of 51 – 0. This committee vote is another step in a 2-year process to reform our health care regulatory process and allow innovation to fight and to cure diseases in our country. America has been a leader in medical innovation and breakthroughs, but despite our continued successes government rules and regulations threaten our leadership in health care innovation.
“Our goal must be to create a regulatory environment where American innovators are not at a competitive disadvantage to foreign companies. Liberating our medical innovators from needless bureaucracy and regulation will ensure Americans are the ultimate winners with improved access to new medicines and medical treatments while protecting US medical and biomedical jobs. This legislation brings hope and medical cures to many patients and their families who have run out of options,” said Cramer.
Background on 21st Century Cures:
- Increased funding for the National Institutes of Health (NIH)
- A new grants program
- An "Innovation Fund," will support young, emerging researchers and offer capstone awards to outstanding established scientists, especially in promising new areas of study such as precision (aka personalized) medicine. There is also an offer of student debt forgiveness extended to young scientists who agree to work as researchers for the NIH.
- A global pediatric clinical trials research network
- Establishing this network would require working closely with regulatory agencies in other parts of the world, such as the European Medicines Agency (EMA).
- Increased availability of data
- Study results from NIH funded research will become standardized and made widely available. This will help prevent redundant research, which wastes millions of dollars
- Council for 21st Century Cures
- A nonprofit public-private corporation will have a mission to facilitate the discovery, development, and delivery of innovative cures, treatments, and preventive measures.
- Patient-focused drug development
- The FDA will take into account patients' reported experience with new drugs, which can then be incorporated into the risk/benefit analysis. The FDA, with support from patient groups, has long wanted to add something like this to their review process.
- Establishing rules for identifying and qualifying biomarkers
- Biomarkers are measurable medical signs, such as pulse rate or blood glucose level, that indicate certain processes, such as disease, are going on in the body. Sometimes they can accurately predict the clinical outcome of those processes and are used as "surrogate" endpoints in clinical trials for serious, life-threatening diseases such as cancer or heart disease. For example, reduced cholesterol is sometimes used instead of reduced mortality as an endpoint in studies looking at heart disease, because waiting to actually demonstrate that people lived longer could take many years and keep a new, effective drug off the market for no good reason.