America Must Not Fall Behind China in Biotechnology – the FDA Needs Stable Leadership – Inside Sources

Among the biggest threats the U.S. faces is the growing competition from China in biotechnology. China is moving with relentless intentionality to advance its capabilities in the areas of clinical research, drug discovery, xenotransplantation and biopharmaceutical development. The National Security Commission on Emerging Biotechnology – created by Congress as a legislative branch advisory entity – warns of the economic and national security consequences associated with China making biotech competition a strategic priority.

Why should every American be concerned? The strength of our health security and resilience as a nation depends largely on our ability to control our own innovation and care. China dominance in biotechnology innovation will result in increasing U.S. reliance on Chinese-controlled supply chains, access to Chinese-manufactured treatments, and the deterioration of a leading U.S. jobs sector.

The memories of every American during the early days of the COVID-19 response remain fresh, as N95 masks were unavailable because they were mostly manufactured in China. As the CDC Director at that time, I viewed that lack of supply chain control as a warning to all of us that we must never cede our health sovereignty to any nation – and particularly China.

This issue of China’s biotechnology dominance push requires immediate attention and steady FDA leadership – in coordination with our national security leaders, and particularly the President. This is not a partisan issue, it is a health security issue, and irrespective of election politics, the confirmation of Dr. Heidi Overton to serve as FDA Commissioner should be among the highest priorities in the lame duck session of Congress.

Senate health committee Chairman Bill Cassidy is not only a physician but he has been a leader in raising awareness about the China biotech problem and advancing the policy dialogue through a report that he published in February. The Chairman reports of China surpassing the U.S. as the leading venue for clinical trials and warns of the U.S. losing its competitive edge in Phase I clinical trials due to streamlined Chinese processes.

Dr. Overton echoed this concern in her confirmation hearing, alerting the Committee that “time is of the essence” as this growing problem “should give pause to every American and to those who serve on their behalf. When we lose this advantage, we lose our health security. And when we lose our health security, we lose everything.” And President Trump clearly understands the threat, as Dr. Overton specifically instructed her to “go fast” once confirmed.

As a physician and infectious-disease researcher, I have witnessed firsthand the central role the FDA plays in turning scientific breakthroughs into effective, safe treatments for patients. Due to the China biotech threat and the acceleration of innovation overall, the FDA is an agency that finds itself in a critical moment to lead the world or fall further behind. A lack of consistent and stable FDA leadership puts at risk the opportunity to reform the agency to advance cutting-edge therapies and stymies investment, as the FDA process is increasingly seen as prohibitive.

Dr. Overton is exceptionally qualified and uniquely possesses a panoramic view formed by her experience as a clinician with a PhD in clinical investigation combined with her time as the top advisor to the President on health policy. She understands that our system is built on scientific trust, and that rigorous assessments of safety and efficacy based on reliable clinical evidence must continue to be the foundation of the FDA’s work. But she also understands that patients should not have to wait for promising treatments because of avoidable bureaucracy, and that American biotech innovators should not be disadvantaged by unnecessary processes that could save lives.

We must move without complacency, while still demanding the gold standard science that has made the U.S. a leader in global health. Blending our demand as a nation for high standards combined with a desire to accelerate innovation should be our nation’s promise to the world and be our competitive advantage over China and the rest of the world.

In warning that ‘time is of the essence,’ Dr. Overton astutely implies that delay is our enemy. Not only does delay enable the emerging China threat, it threatens investment into the next innovation, and it carries real consequences for the patient waiting for the treatment that can save their life.

America should not surrender its leadership in biotechnology due to unnecessary delay or failure to adapt. The FDA needs leadership capable of understanding all of these consequences. A forward-leaning leader who will challenge the status quo while ensuring the mission of the FDA is fulfilled.

Chairman Cassidy has been a consistent leader and clear voice about the looming China threat.  He can continue that leadership by confirming Dr Overton quickly so she can take the necessary steps to regain American dominance in this critical area for patients, the economy, and national security.