In 2019, seven former commissioners of the Food and Drug Administration (FDA), appointed by presidents of both political parties, came together with an unusual warning: the agency responsible for protecting America's health needed to modernize to keep pace with scientific progress and an increasingly competitive world.
Their concern was institutional. FDA's growing responsibilities demanded efficient, independent, science-based decision-making and an organization capable of translating medical breakthroughs into benefits for American patients.
Two years later, six former commissioners again joined together, this time urging President Biden to prioritize the nomination and confirmation of an FDA commissioner. Their message was straightforward: an agency with responsibilities so consequential to the nation's health requires experienced leadership and the scientific independence necessary to carry out its mission.
And again more recently two former commissioners wrote about the importance of confirming Dr. Heidi Overton as the next FDA Commissioner for similar reasons.
The challenges they identified have not disappeared. Rather, they have grown more consequential, placing increasingly complex demands on FDA and underscoring the importance of strong, experienced leadership at this critical moment.
Today, the United States faces intensifying competition from China in biotechnology, strategic dependence on Chinese key starting materials (KSMs) and intermediates used to manufacture affordable generic medicine, and growing pressure to restore the balance between U.S. pharmaceutical innovation and affordable competition.
These are not separate problems. Together, they raise a fundamental question about America's ability to discover, develop, manufacture, and reliably access innovative and affordable medicines upon which its health and economic prosperity depend.
FDA has an essential role in addressing these challenges.
First, the agency must help sustain American leadership in biomedical innovation at a time when China is rapidly advancing its biopharmaceutical capabilities. In February 2026, the Senate Health, Education, Labor, and Pensions Committee released a comprehensive FDA modernization report warning that regulatory bottlenecks and outdated processes threaten American biomedical competitiveness and delay access to lifesaving treatments. The bipartisan U.S.–China Economic and Security Review Commission similarly documented China's expanding innovation and manufacturing capabilities in its November 2025 report to Congress. Modern, predictable, and scientifically rigorous regulatory pathways are essential to keeping groundbreaking research, investment, and innovation in America.
Second, the FDA must help strengthen America's medicine security by mitigating our strategic dependence on China for key starting materials (KSMs) and intermediates used to manufacture affordable generic medicines. The U.S.–China Economic and Security Review Commission warned that concentrated pharmaceutical supply chains could expose the United States to geopolitical coercion and potentially devastating disruptions in access to essential medicines. These concerns are not hypothetical. China has already demonstrated its willingness to restrict exports of critical minerals, and during the COVID-19 pandemic, Chinese state media raised the prospect of withholding pharmaceutical ingredients from the United States. The risk that essential medicines could become instruments of geopolitical leverage underscores the urgency of reducing these dependencies.
As in other critical sectors, reducing dependence on China requires co-investment, co-development, and expanded manufacturing with trusted allies. Applying this approach to essential medicines can diversify upstream production and strengthen pharmaceutical supply security. FDA has a critical role in coordinating with international regulators, identifying supply-chain vulnerabilities, and advancing efficient, accelerated regulatory pathways.
Finally, FDA must help restore the fundamental U.S. public bargain established under Hatch-Waxman: rewarding pharmaceutical innovation while ensuring timely access to affordable generic competition. That principle was subsequently extended to biologic medicines through the biosimilar approval framework.
Today, that balance is increasingly tilted towards the brand sector. Protracted regulatory reviews, unnecessary barriers to approval, and market practices that disadvantage generics (small-molecule and biosimilars) can delay competition, undermine investment and manufacturing sustainability, and deny American patients the access and savings they were promised.
FDA modernization must advance both sides of the equation: accelerating innovation while ensuring that safe, effective, affordable medicine reach American patients without unnecessary regulatory delays. Broader market reforms must complement those efforts so that regulatory approval translates into meaningful competition and affordable patient access.
America's health and economic prosperity are inseparable. A nation cannot sustain scientific leadership, economic productivity, or national security without reliable access to innovative brands and affordable generics.
FDA's responsibilities are too consequential for prolonged uncertainty in its leadership. The one thing Congress should do before leaving for the holidays is confirm Dr. Heidi Overton as FDA Commissioner. She can provide the continuity, accountability, and sustained direction needed to advance the agency's scientific and public health mission. The importance of that leadership transcends administrations and election cycles.
Kathleen Jaeger, J.D., R.Ph. has been an advocate for America’s generics industry for over 30 years and is the CEO of MEDSECUREAN.
