Chaos has become the norm at the U.S. Food and Drug Administration. And it’s putting American patients, not to mention our country’s world-leading life sciences sector, at risk.
Earlier this year, roughly 3,500 FDA employees were laid off. The agency’s Center for Drug Evaluation and Research, which oversees prescription and over-the-counter drugs, will soon be on its third leader since November. Last month, the FDA signaled that it may subject vaccines to stricter approval requirements—without providing evidence explaining why.
For decades, the United States has been the world’s medicine chest—the source of a disproportionate share of the world’s breakthrough medicines. That’s not an accident. Our rigorous, science-driven, and predictable regulatory system is a big reason why.
Inventing a new medicine is an expensive, long-term endeavor. On average, it takes about a decade and roughly $2.6 billion to bring just one successful medicine to market. Those costs are so high in part because nine of every 10 drugs that enter clinical trials ultimately fail.
Yet researchers, companies, and investors have continued to take big chances on promising ideas. Over the past decade, pharmaceutical firms have invested more than $850 billion researching and testing breakthrough drugs.
They’ve been willing to take those chances because they trust that regulators will not erect arbitrary obstacles that keep safe and effective products from reaching patients. Historically, the United States has approved more new drugs per year than European regulators—and has done so faster.
The result has been an explosion in life sciences innovation that has lowered cancer mortality, cured previously untreatable diseases, and given the world hundreds of transformative therapies.
That progress cannot continue if the FDA descends into dysfunction. And that’s precisely what seems to be happening.
The agency’s ongoing reappraisal of vaccines is a case in point. Leadership recently floated a proposal that new vaccines—even routine updates such as seasonal flu or COVID boosters—undergo placebo-controlled trials in order to earn approval. That would represent a major break with decades of policy.
For good ethical reasons, the FDA has long avoided requiring placebo-controlled studies when doing so would mean withholding an already available protective vaccine from part of the trial population.
Worse still, mandating such trials would delay essential vaccines and expose more people to preventable disease. It would make development riskier and more expensive—without any clear scientific justification.
Or consider the agency’s shifting guidance on gene therapy. In November, the FDA reversed a 2024 decision to grant accelerated approval to a breakthrough gene therapy for Huntington’s disease, saying that the data from the phase 1/2 study—which it previously deemed sufficient—was suddenly inadequate.
Drug researchers can adapt to clear, consistent rules. They cannot do their work effectively when the rules change in the middle of the game.
If life-sciences companies and investors come to believe that the FDA no longer offers stable, evidence-based standards—whether for vaccines, gene therapies, or anything else—they will scale back work on treatments that patients desperately need.
America’s competitors will not hesitate to capitalize. China has made no secret of its ambition to become the world’s leading source of pharmaceutical innovation. To that end, its leaders have streamlined elements of their regulatory process and poured substantial resources into biopharmaceutical research and development.
If the FDA ceases to be a predictable source of regulatory guidance—and ends up mired in baseless political disputes—then China will gain a significant advantage in the race for biopharmaceutical supremacy. American patients could find themselves dangerously dependent on a strategic rival for the medicines they need to stay alive.
A chaotic FDA is incompatible with a thriving, competitive market for medical discovery. Any effort to reform the agency must prioritize removing barriers and avoiding delays that keep safe, effective medicines from reaching patients.
As things stand today, however, the FDA appears to be moving in the opposite direction.
