Food and Drug Administration staff cuts may hinder US biomedical innovation

The Hill

3 hours ago

President Trump has rightly emphasized restoring America's economic and strategic independence — from reshoring pharmaceutical production to cutting regulatory red tape. But not all reforms are created equal. Recent restructuring efforts at the Food and Drug Administration may have been well-intentioned, but they risk undermining the very innovation and domestic capacity the president seeks to promote.
In March, Health and Human Services Secretary Robert F. Kennedy Jr. announced a sweeping reorganization of the agency, which in part included the elimination of 3,500 full-time employees at the Food and Drug Administration — many of them senior scientific staff and experienced regulators who served as institutional pillars across drug review divisions. While we all support government efficiency and the secretary's efforts to create a gold-standard regulatory agency, the loss of this institutional memory risks hobbling the expedited pathways that small biotech firms rely on to deliver therapies for rare and life-threatening diseases.
Unfortunately, the impact of these cuts is not theoretical. The Wall Street Journal has reported that some biotech firms have had to delay or cancel clinical trials due to lack of timely Food and Drug Administration guidance. One California biotech firm facing unpredictable delays has even turned to European regulators to move forward with a clinical trial — effectively offshoring American capital, investment and jobs. Others have reported receiving conflicting and confusing feedback from inexperienced FDA staff or no response at all on time-sensitive requests.
But such issues don't just affect companies; they hurt patients, too. Innovation in gene therapies, cancer immunotherapies, and treatments for rare diseases depend on regulatory clarity and speed. Without senior staff to help clarify agency positions, decisions are either delayed or driven by less-experienced personnel unfamiliar with long-standing scientific standards. It's no surprise then that over 200 biotech CEOs, patient advocates and investors — many of them strong supporters of FDA modernization — have expressed their concerns in a letter to Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy (R-La.).
As a former member of Congress who sat on the Appropriations subcommittee overseeing the FDA, I have long supported targeted reforms to make the agency more nimble and responsive. But there is a fine line between streamlining operations and cutting the institutional capacity necessary to do the job. Removing experienced drug reviewers before an adequate backup plan can be put into place not only jeopardizes U.S. safety standards but also undermines our competitive edge.
This matter is not merely a domestic problem; it's a global race. Since 2014, the number of biomedical drugs under development in China has grown twelvefold. Meanwhile, innovation in the U.S. has remained relatively flat. If trends continue, China could match or surpass the U.S. in biomedical innovation within the decade. We have seen this movie before — in semiconductors, in telecommunications, in clean energy. We cannot afford to let biotech go the same way.
The Trump administration's tariff policy was designed to bring pharmaceutical manufacturing back to U.S. shores. But how can we expect capital to stay in the U.S. if our regulatory infrastructure cannot deliver? Delays and unpredictability at the FDA don't just slow down science — they push investors to look elsewhere.
Even the user fee system — critical to funding timely drug reviews and a source of government revenue — has been impacted by the reduction in force. Staff who oversaw the reauthorization of the Prescription Drug User Fee Act have been laid off, raising questions about whether the agency will even be able to continue to collect user fees and whether these government cuts will actually end up costing taxpayers in the long run.
Of course, Kennedy has long been a vocal advocate for health reform. His Make America Healthy Again agenda's focus on combatting chronic diseases and enhancing nutritional standards deserves attention. His focus for such reform is where his background and passion can lead to meaningful improvements. But when it comes to regulating complex biologics and therapeutics, we must be careful about taking actions that could inadvertently stymie scientific progress.
President Trump's vision for American self-reliance will only succeed if it's built on a foundation of regulatory competence and stability. Swift actions should therefore be taken to restore the FDA's core functions, rehire critical staff and unfreeze the hiring of roles essential to America's leadership in biomedical science. The stakes — for patients, for innovation and for national security — are simply too high to ignore.
John T. Doolittle is a former member of Congress who served on the Agriculture, Rural Development, FDA, and Related Agencies subcommittee of the Committee on Appropriations.