Nearly 14.5 million Americans are living with cancer, and more than 1.7 million are expected to be newly diagnosed this year. Cancer—like many other diseases, such as Alzheimer’s, Parkinson’s, and thousands of others—has no cure. Despite United States investments of more than $1.5 trillion in research and development over the past two decades, we have not seen the same level of progress in the discovery, development, and approval of new cures and treatments for patients. In fact, it takes on average $2 billion and more than a decade to bring a new drug to market.
Thankfully, modernizing the discovery, development, and delivery of medical products has become a key focus for policymakers. This week the Senate Health, Education, Labor, and Pensions (HELP) Committee held the first of three scheduled mark-ups on bipartisan medical innovation legislation, following almost a year of hard work by bipartisan working groups within the Committee. This action follows passage of the 21st Century Cures Act by the House of Representatives last summer.
As co-chairs of the Bipartisan Policy Center’s (BPC) initiative on Advancing Medical Innovation, we have a few thoughts of our own. First, it is critical that we not let up. Cutting edge technologies, treatments, and cures can be life-changing and life-saving for patients in need. Though we enter an increasingly political season in Washington, policymakers can and should build on the considerable hard work that has been done to date and pass medical innovation legislation this year. Second, we have bipartisan solutions right here in front of us. As a former Senator and Congressman, we appreciate the hard work it takes to craft carefully negotiated, bipartisan legislation that seeks input from all potentially affected stakeholders.
About six months ago, BPC released recommendations under our leadership for improving the discovery, development, and delivery of cures for patients. They focus on improving the medical product development process, improving regulatory clarity, strengthening the FDA’s ability to carry out its mission, and increasing investments in medical products to address unmet and public health needs. Here are ten key areas we believe are ready for bipartisan action this year:
1. Strengthening the FDA by increasing scientific expertise and capacity through more flexible and efficient hiring practices, improved access to scientific conferences, and more effective and expanded use of public-private partnerships.
2. Providing support for personalized and precision medicine to bring life-saving treatments to Americans with cancer, Alzheimer’s, Parkinson’s, and other diseases for which there is no cure.
3. Integrating patient perspectives into benefit-risk assessments by clarifying processes and timelines for submission of patient data and methodologies for collection and assessment of data for benefit-risk.
4. Improving the interoperability of health information technology (IT) to support greater sharing of information electronically to improve the health of individuals; support higher quality, more cost-effective, patient-centered care; and advance biomedical innovation.
5. Expanding the generation and use of real world evidence drawn from clinical, claims, and patient-generated data to improve the development and delivery of drugs and devices; support the FDA’s development of a framework and methods for evaluating and enabling the use of real world evidence approaches.
6. Reducing uncertainty about whether and how health IT is regulated.
7. Expanding the qualification and use of drug development tools—such as biomarkers and patient-reported outcomes—to develop safer and more effective medical products, and increase the efficiency and effectiveness of the drug development process.
8. Advancing a new regulatory pathway for cellular therapies to enable patient access to safe and effective treatments to rejuvenate and regenerate diseased organs and tissues.
9. Improving the regulation of combination products by addressing lack of coordination among centers, improving timeliness of responses, providing greater clarity of requirements, and assuring consistency.
10. Enabling the sharing of truthful, non-misleading, scientific information for all uses of approved medical products, including those that are off-label.
Bipartisan action to advance medical innovation for healthier Americans is now within reach. We urge Congress to sustain the momentum to enact practical, meaningful bipartisan medical innovation legislation. It’s time to take action to accelerate the delivery of safe and effective cures for Americans.
Frist is a cardiothoracic surgeon who served in the Senate from 1995 to 2007 and was Senate Majority Leader from 2003 to 2007. Gordon is a lawyer who served in the House from 1985 to 2011. The two co-chair the Bipartisan Policy Center’s Advancing Medical Innovation Initiative.