President Donald Trump’s first term championed a vision of American healthcare rooted in innovation, patient choice, and pro-life values. That first term delivered historic achievements at the Food and Drug Administration (FDA) – from fast-tracking lifesaving therapies, approving a record number of generics in 2017 and 2018 under the Drug Competition Action Plan, and advancing drug price transparency. Unfortunately, the recent upheaval at the agency and more broadly at the Department of Health and Human Services (HHS) is unravelling that progress with the consequences already hurting Americans.
In an erratic attempt to carry out President Trump’s directive to “course correct and refocus” at the FDA, a wave of restructuring by HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary has disrupted the FDA’s functionality, destabilized investment in American biotech, and frustrated patients reliant on accelerated pathways for breakthrough treatments. These misdirected changes now risk undermining President Trump’s overarching health policy objectives, from reshoring pharmaceutical manufacturing to promoting a culture of life at the nation’s health agencies.
Though many DOGE cuts removed red-tape bureaucrats, they also dismissed senior scientists and regulators critical to drug development.. These scientists and regulators provide the clarity, continuity, and communication essential to companies navigating the agency’s complex approval pathways. Their absence causes regulatory bottlenecks, approval delays, and even canceled dispute resolution meetings. The gravity of these disruptions compelled hundreds of biomedical innovators, investors, and patient advocates to sign a public letter expressing their concern about the current state of the agency.
This uncertainty has consequences. Companies are already offshoring trials to China to escape FDA ambiguity. But more troubling is that these cracks in the regulatory system are threatening patients while handing China a geopolitical advantage. As former Trump Undersecretary of Commerce for Intellectual Property Andrei Iancu recently warned, “Any way you cut it… China is already leading, or knocking on the door” in biotech innovation. Licensing deals for Chinese-developed drugs now account for nearly 40% of U.S. activity, up from less than 3% five years ago. Meanwhile, U.S.-based firms are slashing research and development budgets amid regulatory unpredictability and rising costs tied to tariffs and supply chain delays.
Ceding biotech innovation to Communist China isn’t just a blow to America’s economic competitiveness; it’s a blow to our moral authority as well. The Trump administration vowed to uphold life-affirming principles. China’s clinical trial system does not operate with the same ethical safeguards as ours. As FDA delays pile up and FDA reliability erodes, innovators seeking to develop gene therapies for rare diseases may have no choice but to conduct trials in countries like China where there are few protections for participants and human dignity is often ignored.
This point comes into even sharper relief when the very agency tasked with protecting life denies vulnerable children access to therapies that could extend or save it. In July 2025 alone, for instance, the FDA rejected Ultragenyx’s UX111, a gene therapy for children suffering from Sanfilippo syndrome type A – a rare, fatal neurodegenerative condition that typically claims young lives before adolescence – over manufacturing technicalities, despite the lack of any meaningful alternatives for these families. It also halted shipments of Sarepta’s Elevidys, the only approved treatment for Duchenne muscular dystrophy, a devastating disease that gradually robs children of their ability to walk, breathe, and ultimately survive into adulthood. The FDA only partially reversed this decision after a wave of outrage from parents and clinicians.
Taken together, these actions reflect a concerning trend: Instead of accelerating the actualization of hope, the FDA is delaying it. For the most vulnerable patients, including children, a delay may be the difference between life and death. Backfilling career staff in critical scientific roles with poorly suited replacements is dangerous. Dr. Vinay Prasad, who has been elevated to lead the Center for Biologics Evaluation and Research (CBER), exemplifies this problem. Prasad is a self-described “political liberal” who has emphasized that he stands “on the side” that views abortion as healthcare, Rather than advancing a culture of life and innovation, his tenure has introduced skepticism toward pediatric therapies and reinforced a pattern of denials that has left desperate families with fewer options and less hope.
Let’s be clear: Streamlining government is a worthy goal. But there’s a difference between pruning deadweight and gutting expertise. Under Trump’s first term, the FDA broke records in drug approvals, advanced Right-to-Try legislation, and led the fastest vaccine development campaign in history all while maintaining high scientific standards. Today’s reality stands in stark contrast: regulatory inconsistency and mission drift that have left disillusioned biotech investors walking away from U.S. markets.
President Trump has the opportunity and the obligation to reassess the FDA’s current trajectory. The White House must remind Secretary Kennedy and Commissioner Makary of the importance of biomedical innovation and make it clear to them that it’s time to stabilize the FDA, re-center the agency on science, and reaffirm our commitment to both life and leadership in the biotech frontier. In the race for medical breakthroughs, delay means death and the United States cannot afford to lose this race to red tape or to Red China.
