After a Contentious Election, A Rare Unifying Force: Pass Cures Now

Ellen V. Sigal, Ph.D., is the Chair and Founder of Friends of Cancer Research

Mark McClellan, M.D., Ph.D., is the Director of the Margolis Center for Health Policy at Duke University and was Commissioner of the FDA from 2002 to 2004.

After a deeply contentious election, Congress has an opportunity to embrace common ground. The House and Senate should pass the 21st Century Cures Act to bolster the life-saving work of the Food and Drug Administration (FDA) and National Institutes of Health (NIH).

The “Cures bill” unites us — a former FDA Commissioner and the founder of a non-profit that advances innovation in cancer research and treatment — because it brings the latest scientific opportunities to the urgency of saving lives. Defeating life-threatening diseases is a priority that should transcend political divides — after all, disease knows no party or ideology.

For two years, bipartisan leaders in Congress, with the help of expert doctors and scientists, have crafted a package of the most critical programs and regulatory changes needed to improve the nation’s health and unlock the potential of the FDA and NIH. Congress is expected to vote on the bill after Thanksgiving, perhaps the bill’s last clear chance.

The Cures bill deserves urgent support not only because it is about accelerating cures, but also because it reflects extensive and comprehensive work on a bipartisan basis over two years to identify effective ways to do it. The bill translates recent progress in scientific understanding of disease mechanisms, data integration and analysis, and patient engagement to streamline and speed the development of medical treatments while enabling a deeper understanding about their safety and effectiveness for particular patients. It gives the FDA and NIH needed funding, staff, and hiring flexibility to take advantage of these opportunities. These new tools to promote health also help create jobs and boost American competitiveness globally.

The Cures bill draws inspiration not from Washington insiders, but from scientists and medical professionals who confront disease every day. Resting on the bedrock premise that patients come first, the Cures bill includes a set of reforms that will yield better science, support, and structures — providing more tools for the FDA to use without compromising its gold standard of efficacy and safety.

For example, the bill enables the power of collaboration and big data to bring 21st century tools and richer sources of patient information to bear in the development and use of new treatments. It also helps the FDA incorporate patient perspectives as never before, making patient preferences and self-reported information integral to drug development. Finally, the bill would advance the development of precision medicine, reflecting a scientifically-driven shift toward more targeted and effective treatment. Ultimately, the Cures bill will help speed new, improved treatments to those patients with the most urgent needs.

While updated regulatory approaches can make a difference, they require adequate resources to be effective. We understand how crucial it is to support the organizations that research, develop, test, and deliver responses to our most difficult health challenges. The Cures bill provides essential support to the FDA and billions of dollars to the NIH for transformative biomedical research. This funding is a vital, high-payoff public investment in America’s research and development capabilities.

Beyond funding, the Cures bill enables the FDA to recruit and retain world-class scientific talent to help drive innovation. Bypassing outdated hiring procedures, the bill will finally empower the FDA to fill its many open roles, particularly those related to the development of breakthrough treatments. Fully staffing the agency with the best and brightest will help ensure its ability to take advantage of the latest scientific progress.

The Cures bill also takes an important step toward a more patient-focused, not technology-focused, approach to regulation through the implementation of an Oncology Center of Excellence, a key component of the White House’s visionary Cancer Moonshot, led by Vice President Biden. Through new collaborations, the Oncology Center can make a difference for cancer patients who cannot wait for inefficient approaches to developing new treatments to yield results. And the center can serve as a model for patient-focused regulation in the future.

It’s no wonder that the Cures bill has attracted rare bipartisan support. Ultimately, we cannot afford to have two of the nation’s premier public health and safety organizations operating with anything less than the best possible methods, resources, and people.

Regardless of who occupies the White House, the NIH must advance biomedical research to reduce the burden of disease, and the FDA must discharge its responsibility to protect and promote the health of the American people. From the standpoint of effective government, the Cures bill will enable these agencies to maximize the impact of the public and private resources devoted to developing new cures. From the standpoint of patient advocacy, the costs of the alternative — continued inaction — are simply staggering.

Congress should pass the Cures bill to leverage the latest science to save lives, and to show the nation that, together, we have the capacity to heal when it matters most.