OPINION:
America has a long history of building world-changing institutions, but history also shows that even great institutions can become slow, bloated and overly bureaucratic when they lose sight of their missions.
For years, NASA became a cautionary example. Despite employing some of the world’s best engineers and scientists, the agency became increasingly defined by cost overruns, repeated delays and a culture that too often prioritized avoiding failure over pursuing progress.
Missions became more expensive. Timelines slipped. Bureaucracy evolved from a safeguard into an obstacle.
Then SpaceX proved there was a better way. Rather than accepting endless delays as the unavoidable cost of doing business, SpaceX embraced rapid iteration and demanded accountability. It moved faster, lowered costs and helped restore American leadership in space.
With the resignation Tuesday of Food and Drug Administration Commissioner Marty Makary, President Trump now has an excellent opportunity to apply those lessons at the FDA.
Mr. Trump has repeatedly spoken about the need for America to outcompete China and rebuild domestic pharmaceutical manufacturing capacity. Just as important, he has consistently recognized that excessive bureaucratic barriers can prevent American innovation from reaching the people who need it most. Those instincts are exactly right.
During his first term, Mr. Trump signed the Right to Try Act of 2017, which expanded access to investigational treatments to patients who are afflicted with rare diseases or are terminally ill and have run out of options. It reflected a simple but powerful idea: When someone is fighting for their life, Washington should not make that battle harder through unnecessary delay.
Unfortunately, that same urgency was increasingly absent at the FDA under Mr. Makary.
During his tenure, the agency too often drifted toward the same institutional mindset that once held back NASA. Drug developers increasingly described a review process defined by uncertainty. Guidance shifted midstream. Timelines have become harder to predict. Companies can spend years following one regulatory road map only to find the rules of the road suddenly changed.
Patients have been left to suffer the consequences.
Consider Replimune’s experimental melanoma treatment, which the FDA rejected last year. The company said it followed the FDA’s guidance throughout the review process, only to be hit with new objections late in the process that had never been raised before.
Replimune called the rejection “surprising,” and its stock collapsed afterward. The agency also temporarily halted shipments of Elevidys, the only approved gene therapy for Duchenne muscular dystrophy, before partially reversing course in response to backlash from families and advocates.
For patients and investors alike, the message has become increasingly clear: The rules can change without warning.
Reforming the FDA doesn’t mean the agency should abandon rigorous scientific review, but there is a difference between being careful and becoming paralyzed. Today’s system often creates far greater consequences for approving a treatment that later encounters complications than it does for delaying a promising therapy for years.
Saying “Not yet” becomes the safest bureaucratic decision, even when patients are pleading for urgency. Meanwhile, America’s competitors are moving aggressively.
China has rapidly expanded its biotechnology footprint and invested heavily in advanced drug development and manufacturing. While the United States burdens innovators with more red tape, Beijing is working to become the dominant player in industries that should remain strategic American strengths.
We have seen this pattern before. America assumed its industrial dominance was permanent in critical manufacturing sectors and learned otherwise. We should not repeat that error with biotechnology.
A better FDA would protect patients while recognizing that speed matters too. It would create clearer pathways for rare disease treatments. It would modernize outdated review systems by using artificial intelligence where appropriate. It would recognize that the mission is helping patients access safe and effective treatments as quickly as possible.
Yet all that requires leadership willing to challenge institutional inertia rather than defend it.
Mr. Trump was right to challenge systems that had grown detached from their original purpose. America does not need an FDA that behaves like the old NASA. It needs an FDA that thinks more like SpaceX: focused on results, willing to innovate and capable of moving at the speed modern patients deserve.
Mr. Makary showed that he could not deliver that transformation, and Mr. Trump now has an opportunity to find a leader who can.
• Todd Tiahrt is a former member of Congress who served as the ranking member of the House Appropriations subcommittee on labor, health and human services, education, and related agencies.
Please read our comment policy before commenting.