The Senate has a chance to cut regulation and promote medical innovation.
As doctors, patients and former U.S. senators, we’ve seen firsthand how medical innovation benefits patients. Those on our operating tables and in our practices—and we ourselves when we’ve needed medical care—have benefited from breakthroughs in science and newly approved treatments that translate into better health and longer lives.
Yet, tragically, millions of Americans are still suffering and dying from untreatable diseases or the lack of better treatment options. Now is the time to pass legislation that we know will safely speed treatments to patients in need. Lives are at stake.
Before the Senate is a powerful medical-innovation package of 19 bills—a companion to the House-approved 21st Century Cures Act—that will streamline the nation’s regulatory process for the discovery, development and delivery of safe and effective drugs and devices, bringing the process into the new century.
Today, researchers and developers spend as much as $2 billion to bring a new drug or therapy to market and the regulatory process can take more than 10 years. That’s too long and too expensive for the five million Americans suffering from Alzheimer’s; the 1.6 million who will be diagnosed with cancer this year; the 60,000 Americans with Parkinson’s; and the nearly 800,000 people who die from heart disease each year.
This legislation, crafted by the Senate’s Health, Education, Labor and Pensions Committee, touches every American. Each of us has personal health battles or knows family members and friends who are fighting against devastating diseases. Passing this package will help ensure that patients’ perspectives are integrated into the drug-development and approval process and speed up the development of new antibiotics and treatments for those who need them most. It will also give a big boost to PresidentObama’s cancer “moonshot” and his Precision Medicine Initiative, which will map one million genomes and help researchers develop treatments for diseases more quickly.
The U.S. has invested more than $30 billion in electronic health records over the past six years. Yet the majority of systems still are not able to routinely exchange patient information. This legislation will improve interoperability and electronic-information sharing across health-care systems, playing a fundamental role in improving the cost, quality and outcome of care. It encourages the adoption of a common set of standards to improve information sharing. It also allows patients easier access to their own health records and makes those records more accessible to a patient’s entire health team so they can collaborate on treatment decisions.
The legislation will also improve the Food and Drug Administration’s ability to hire and retain top scientific talent, which is vital to accelerating safe and effective treatments and cures. Additional provisions in the bills will improve the timeliness and effectiveness of processes for developing important combination products, such as a heart stent that releases medication into the body.
Alzheimer’s is already the most expensive disease in America, and the number of people diagnosed with this debilitating neurological condition is expected to nearly triple to 13.8 million by 2050. This legislation will help advance our understanding of neurological diseases and give researchers access to more data so they can discover new therapies and cures—giving families hope for the future.
Collectively, these 19 bills are expected to deliver new, safe and effective treatments. Any political impediments to this should be overcome immediately. We believe, along with patients, providers, innovators and policy makers, that the nation’s current process for developing and delivering drugs and devices to cure life-threatening diseases must change.