Don't fix Medicare Part D if it ain't broke
The time to act is now: Bipartisan action will accelerate cures for Americans
With the election over, speculation is rampant on what this means for politics and policy in 2017. We need to take a step back however, and realize there is critical work to be completed by Congress in 2016, to set the stage for a new generation of medical innovation, and demonstrate to the American people that Washington is not broken.
Congress has four remaining work weeks in Washington to hash out the budget and hopefully finish work on the "21st Century Cures" legislation which will accelerate the discovery, development, and delivery of safe and effective medical therapies. As medical doctors we have witnessed the potential of life-changing treatments, and as a former Senate Majority Leader and former Food and Drug Administration (FDA) Commissioner who have spent years in public service - we recognize this rare and exciting opportunity for Congress to pass legislation that will affect the health and well-being of millions of Americans suffering from diseases today with no cure.
The Cures legislation is the product of two years of negotiation, resulting in nearly unanimous support among members of the House of Representatives and the Senate Health, Education, Labor, and Pensions (HELP) Committee at a time when many believed Washington was incapable of compromise. Indeed, in late September, Senate and House leadership, and bipartisan leaders in the Senate HELP Committee and House Energy and Commerce Committee committed to getting a bill passed this fall.
Some small roadblocks remain, namely agreement on funding sources and levels. This is worth working through. If 21st Century Cures is not passed before the end of this term, the new Congress of 2017 will need to start all over again. This is a tragedy on many fronts; progress in biomedical research and creation of innovative therapies will be delayed, precious time and energy will be diverted from other pressing legislation, and the new administration will be deprived of having a foundation designed with today's medical advances in mind.
Key elements of the medical innovation legislation advanced by the House of Representatives and Senate HELP Committee ripe for action include:
- Enhancing FDA's ability to hire and retain staff with scientific expertise, so that our best and brightest have added incentive to engage in public service;
- Advancing the President's Precision Medicine Initiative to shift from one-size-fits-all medical care to individualized treatments, tailored to a patient's genetic makeup, environment and lifestyle;
- Supporting the Vice President's Cancer Moonshot, to make more therapies available to more patients, while improving ability to prevent and detect disease early;
- Involving patients as partners in the development of drugs and devices to ensure their experiences are reflected in assessments of treatment benefits and risks;
- Improving regulatory processes associated with new emerging therapies such as regenerative medicine and hybrid products that are not pure devices, drugs or biologics, such as drug-emitting skin patches for treatment of early Parkinson's disease;
- Increasing use of real-world evidence - data that reflects the actual experience of patients outside of clinical trials - to inform the development, approval, and surveillance of medical products;
- Clarifying regulatory authority around health information technology to increase private sector investment in innovation in the U.S.; and
- Increasing electronic information sharing and interoperability to improve health, advance research, and support higher quality, more cost-effective, patient-centered care.
Simply put, this legislation will reduce the cost and time to bring drugs or devices to market while maintaining product safety, increase funding for vital research that accelerates the discovery of new therapies for today's incurable diseases, and give our federal agencies not only new resources, but also new policies and practices to optimize their role in advancing health care treatments for Americans.
The health and wellness of our country is not a partisan issue. After nearly two years of divisive language from a lengthy presidential campaign, we have an opportunity to demonstrate that Washington can still come together for the betterment of our country. The Cures medical innovation package is a bipartisan solution to some of our greatest medical challenges today, and can be a message of hope for those skeptical that the federal government is still capable of governing. We strongly urge Congress to pass comprehensive medical innovation legislation in 2016.
Sen. Frist is a surgeon and former U.S. Senate Majority Leader who serves as the co-chair of the Bipartisan Policy Center's Advancing Medical Innovation Initiative. Dr. von Eschenbach is a former commissioner of the Food and Drug Administration and former director of the National Cancer Institute who serves as a senior advisor to Bipartisan Policy Center's Advancing Medical Innovation Initiative.
The views expressed by authors are their own and not the views of The Hill.