After 100 days of leading the Food and Drug Administration (FDA), I have seen first-hand how the agency needs to modernize and adapt to the health challenges facing our country. That’s why we’ve been running at full speed over the past few months to do just that, taking action to remove petroleum-based dyes from the food supply, reduce animal testing in drug development, empower our scientific reviewers with powerful AI tools, and create pathways for better infant formula and other products to come to market. And that’s just the start of our effort.
Despite the genius of American scientific discovery, a new medication will take over 10 years on average, and more than $1 billion, to come to market—while American children remain the sickest in the developed world. Given the tremendous investment and might of the U.S. health care system, we can and must do better. We need new approaches.
Food and Drug Administration Commissioner Marty Makary speaks as he joins President Donald Trump in the Oval Office at the White House on May 5, 2025, in Washington, D.C.
Anna Moneymaker/Getty Images
In the drug space, the FDA is in competition with international regulators in which we’ve lost ground in recent years. Our own arcane and slow processes are chiefly to blame. New research and development investment is moving to China and Australia, which have more streamlined regulatory processes. If the FDA does not cut the red tape that burdens any bureaucracy over time, the U.S. will lose valuable market access and investment.
On my recent six-city listening tour with drug maker CEOs, the theme of modernization has emerged loud and clear. The FDA often requires mountains of paperwork, data, and tests that are time-consuming and extremely costly, but don’t contribute any additional safety value. Some applications are hundreds of thousands of pages! The only people who stand to benefit from such a large application are regulatory consultants.
Let me be clear, the FDA can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process. In fact, we’re already doing it. In addition to FDA staff now using a powerful AI-based tool, we are piloting more streamlined approval pathways. I recently announced a national priorities pilot program to reduce the amount of time it takes for FDA to reach a drug approval decision from nearly a year to just one to two months. To accomplish this short decision time, companies will submit the lion’s share of the drug application before a clinical trial is complete so reviewers can begin work reviewing the manufacturing and proposed labeling portions of the application ahead of the final trial read out.
Importantly, given the proliferation of unique and innovative therapies being developed today, including novel cell and gene therapies, it is common sense to tailor the approval process to the condition being treated.
Embarrassingly, the FDA has required routine animal testing for new drugs that are already approved in Europe and used by thousands. More broadly, FDA has dragged its feet in shifting from animal testing to use of modern toxicology methods—such as AI-based computational models, organoids or organ-on-a-chip—that can, in appropriate contexts, be better predictors of how a drug will affect humans. Animal testing started to become a standard tool for safety testing in the late 1930s. It made sense in that day, but there are better ways to get the job done today. Our new initiative to reduce animal testing brings the FDA into the modern era, not as a follower, but as a leader.
We are also focused on improving communications with applicants, and with the public. Moreover, this week we announced that FDA drug decision letters will be made public. This will enable future applicants to see how the FDA thinks. Markets like predictability. It’s also in line with our goal to increase transparency so the FDA is no longer a black box, resulting in drug developers spinning their wheels engaging in expensive and time-consuming guesswork.
Looking elsewhere under the hood, we’ve found that the FDA’s existing mechanisms for monitoring a drug’s safety and efficacy are laughably ineffective and fragmented. The result is that important safety signals from real-world data may go unnoticed, even though we could now have the technological capability to collect and analyze this de-identified data. Using big data for better post-market safety monitoring will generate better information to protect the public and help clinicians make nuanced, informed decisions with their patients.
On the food side, we’ve been long overdue for an infusion of common sense and decisive action to remove harmful and unnecessary chemicals and additives from our food supply. In the 20th century, food companies found ways to improve shelf stability and reduce food insecurity across the globe. But we face a different set of crises today, such as the fact that 40 percent of American children have a chronic disease like diabetes or obesity.
This wasn’t caused by a generation of kids suddenly lacking the willpower to eat healthy. The fault largely lies with our food supply. Among other issues, our food has been overloaded with chemicals and additives—many of which are unhealthy and unnecessary—without oversight from the FDA.
What has stuck out to me most has been the extent to which the people working in the food industry are on board and want to help. They want to do the right thing for our food supply—their families eat at the same grocery stores as everyone else.
Even as I’ve become more deeply convinced of the urgency and gravity of the problems we face, my experience inside the agency has also convinced me of our ability to succeed overwhelmingly in the face of these challenges—but only if we act boldly.
For one thing, we have better tools at our disposal than ever before. Big ideas that were previously just dreams—such as using AI and big data to build synthetic control arms, conduct post-market analysis, or assist with scientific reviews—are now becoming a reality.
Critically, the FDA staff has demonstrated their deep commitment to the mission of the FDA. I am deeply encouraged by the vast number of FDA staff I meet who want to be a part of the solution. They have big ideas and share a sense of urgency to break out of our stagnant, bureaucratic processes.
Change is hard. I feel that now more than ever. But America rose to global leadership in biomedical science because we had the ability to think creatively and innovate. If we restore that tradition of bold thinking, we’ll continue to lead the world for generations to come.
Marty Makary, MD, MPH, is the commissioner of the Food and Drug Administration.
The views expressed in this article are the writer’s own.