Our nation’s health regulators stand at a crossroads. In one direction lies advancement through cutting-edge programs; in the other are practices that no longer reflect our best scientific insight. Health officials want to move forward, but external conditions are holding them back.
President Trump can help our nation’s public health talent take the promising path forward by embracing groundbreaking regulatory reforms. Such audacious action will ensure America’s global leadership and national health.
In December 2016, Congress overwhelmingly passed the 21st Century Cures Act. Implementing that bipartisan legislation now falls to Trump and the 115th Congress.
Having spent decades fighting to improve treatment and safety for cancer patients, I was thrilled by the bill’s passage. It promises indispensable changes that will let the Food and Drug Administration take advantage of the most advanced science to tackle cancer without sacrificing safety.
The bill’s first test is the implementation of the FDA’s Oncology Center of Excellence. Under the brilliant leadership of Dr. Richard Pazdur, the center fundamentally reimagines the FDA’s approach to cancer. Today, medical products for preventing, detecting, and treating cancer are reviewed in different parts of the agency. That can be inefficient and hinder access to cutting-edge care. To remedy that, the center will shift from a product-centered approach to a patient-oriented one, connecting previously segregated areas, speeding drug development, enhancing patient input, and eliminating impediments to progress.
The center is an essential early initiative of the Cures Act that will yield concrete benefits for patient longevity and quality of life. The Trump administration should embrace these efforts. Beyond saving lives, its support can help America achieve primacy in public health, furthering our nation’s global leadership and competitiveness.
How does backing the center ensure that primacy?
First, reorganizing the FDA will yield renewed leadership on oncology products. Our country has a strong track record on drug development. But as the creation of new cancer treatments becomes increasingly global, the United States must drive this work efficiently, foreign bureaucracies notwithstanding. A revitalized FDA can ensure that America is first to receive safe, effective products and its patients are first to benefit from them.
Next, by embracing a robust Oncology Center of Excellence, Trump can advance two key administration goals: infrastructure investment and reducing onerous regulation. Combining a plan that includes scientific infrastructure with easing regulatory burdens can help America remain a desirable market for pioneering therapies.
Promoting American leadership in battling life-threatening diseases is a challenge. The center of excellence approach provides solutions to many of them. By empowering health entrepreneurs and uniting them with regulators and researchers, the model invites creative disruption to reshape therapies.
Optimizing innovation is also vital, and that means connecting the FDA to other cancer-focused institutions. Here too, the center offers answers. By serving as a hub for external engagement with academia, industry, and other groups, the center can efficiently build on existing partnerships.
Still, these improvements are meaningless without the right people to implement them. Hiring elite scientific talent remains a vital component of the path forward. Though the Cures Act removed anachronistic hiring restrictions at the FDA, a new pitfall has emerged.
President Trump’s hiring freeze for federal workers could hamper the new center. With hundreds of open roles, the FDA would struggle to meet its existing obligations, let alone implement new programs. Ample funding exists for these roles, so it would be wrong to prevent the FDA from filling them. Those vacancies threaten the agency’s delivery of closely tailored therapies to individuals in need.
The president’s executive order exempts hiring federal employees who are “necessary to meet … public safety responsibilities.” Surely the FDA’s essential public health role is integral to meeting such responsibilities.
Cancer will soon become the nation’s leading cause of death. As long as the center lacks adequate staff, patients will not benefit from its fullest efforts. Against a public threat of such daunting scope, the Trump administration must exempt unfilled FDA roles from the hiring freeze and longer-term cuts. It is not only the debt we owe to those taken too soon by cancer, but also a wise investment that offers a handsome return on investment that a businessman like Trump cannot ignore.
In addition to giving the center a full staff, appointing an FDA commissioner is also essential to fulfilling the transformative potential of the center. For that role, President Trump should appoint an individual who appreciates the nuanced challenges of fighting disease. He or she should understand the agency’s workings and revere its commitment to safety and efficacy.
Most of the legwork necessary for transformative change is already done. If adequately supported, the FDA and Oncology Center of Excellence can yield tremendous benefits for our nation’s health, economy, and image.
Investing in defeating cancer will reward the new administration with an early win that demonstrates how American innovation can solve vexing goals. Even more important, it will give cancer patients promising options and renewed hope. Neither hiring freezes nor politics should obstruct this vital endeavor to improve their lives.
Mr. President, please empower the FDA to battle the destructive forces of cancer with its very best.
Ellen V. Sigal, PhD, is founder and chair of Friends of Cancer Research, an advocacy organization based in Washington, D.C.