Confirm Heidi Overton as FDA commissioner

OPINION:

In nominating Heidi Overton to lead the Food and Drug Administration, President Trump proclaimed, “We need her leadership at the FDA now to ensure that the U.S. remains the WORLD LEADER for Scientific Discovery and CURES.”

He is right.

Biotechnology is a cornerstone of the 21st century. This general-purpose technology is essential to prosperity and human flourishing and is worth tens of trillions of dollars in the coming decades.

Although the United States remains the best place in the world to develop innovative biotechnologies, President Biden’s administration oversaw the offshoring of clinical development, threatening our global leadership in developing new treatments and cures.

In 2021, China surpassed the U.S. in the global share of Phase 1 clinical trials. In 2024, China surpassed the U.S. in the total number of registered clinical trials. Chinese ambitions go much further. They want to supplant the United States in all aspects of drug development to maximize geopolitical leverage.

Over the past year, China has supercharged its efforts by implementing aggressive new laws criminalizing common practices of Western researchers, investors and executives. A new data sovereignty regime encompasses updates to the Cybersecurity Law, the Data Security Law and the Personal Information Protection Law.

China has set forth new decrees on supply chains, foreign compliance rules and foreign trade compliance. These laws establish a centralized new bureaucracy to exert control over information, with extensive powers, including exit bans, seizure of assets and intellectual property, and imprisonment.

Taken together, these incursions into biotechnology and data are a clear, serious threat to the well-being of the American people and the national security of the United States.

Consider this scenario: A mysterious illness appears to have been manufactured for malign purposes, but the country in which the disease originated refuses to supply information, critical supplies or advanced research. Worse, it disrupts access to the supply chains necessary to save lives and beat the disease.

Today, Americans can rest assured that our vast clinical development infrastructure would produce a countermeasure to protect Americans first, as Operation Warp Speed demonstrated several years ago when we encountered a version of the above scenario.

Yet if the current trend of offshoring development to China continues, that infrastructure — researchers, labs, trial sites — may not exist the next time a major pandemic threatens the lives and livelihoods of Americans.

The loss of global leadership in biotechnology could seep into our everyday lives. American patients have access to the best clinical trials in the world, providing hope for those with complex and deadly diseases. The loss of scientific infrastructure and access to cutting-edge treatments would be devastating.

Already, some reports point to patients “voting with their feet” by choosing Chinese over American institutions, an early warning sign of possible erosion.

The good news: There is still time to act. The offshoring of clinical development can be reversed by modernizing the regulatory environment in the U.S. to ensure that this research can be done domestically just as easily, safely and effectively as anywhere else in the developed world.

This is perhaps the single most important step to preserving America’s status as the global leader in biotechnology.

Although there is still time to act, there is no time to delay. The FDA needs bold leadership to secure America’s future.

This is why I support the swift confirmation of Dr. Overton’s nomination as commissioner of the FDA.

At the White House, I worked closely with Dr. Overton to identify commonsense reforms that would begin to streamline the FDA’s antiquated bureaucracy and restore American leadership in clinical drug development.

Through Operation TrialBlazer, more than $638 billion in new investment and the restored enforcement of foreign regulatory compliance, we have made a start. Still, much more work remains.

We should send Dr. Overton to the FDA without delay. A well-respected medical professional, public health expert and public policy leader, Dr. Overton will bring the necessary reforms and advocacy to the FDA to protect American leadership and defend U.S. national security interests in biosecurity and biotechnology.

We can and will win this race. We do not have time to wait.

• Andy Baker is a former deputy national security adviser to President Trump.