Luciana Borio and Phil Krause , 2025-04-18 08:30:00
The first few weeks in office are never easy, but the early stumbles of Marty Makary, the new commissioner of the Food and Drug Administration under the second Trump administration, are cause for concern. Confirmed swiftly, he enjoyed broad support from the biotech industry, which hoped that he would usher in a new era of scientific leadership at the agency.
Instead, he inherited an embattled FDA just days after sweeping budget cuts mandated by the Department of Government Efficiency (DOGE) rattled the agency’s workforce and shocked the life sciences sector.
Then came a classic rookie misstep: an 11th-hour delay of a long-anticipated and uncontroversial vaccine approval, despite months of expert review and a clear path to market.
No one knows whether the delay stemmed from the commissioner’s office asserting unnecessary oversight or interference from the Department of Health and Human Services. Either explanation is troubling. As former leaders at the FDA, we believe this is a pivotal moment — one that calls for recalibration, not retrenchment.
Here’s what the new commissioner should prioritize:
1. Strengthen the scientific review teams — the agency’s beating heart
FDA’s review divisions are staffed by multidisciplinary teams of scientists, physicians, biostatisticians, and regulatory experts who are deeply committed to the public good. Some teams are stronger than others, and a few are world-class. The goal should be to make every review team exceptional.
Frustratingly, this goal can’t be achieved through legislation or better compensation alone. It demands smart recruitment, clear expectations from leadership, and a culture that rewards scientific rigor paired with the recognition that nobody benefits when approvals of potentially lifesaving new products are delayed.
Too often, review teams are criticized for being capricious or overly academic. But the best ones are methodical, innovative, and efficient — and they should be held up as the standard.
2. Respect — don’t override — scientific judgment
In recent years, top-down overruling of review teams has become more frequent. This trend is dangerous. If a single official is overturning expert recommendations, either that person is yielding to political pressure or the review teams are getting it wrong. Neither scenario bodes well for public trust or biomedical innovation. The commissioner must make it clear that decisions will be science-based, transparent, and consistent with statutory standards.
3. Stay in FDA’s lane
FDA’s mandate is to evaluate safety and efficacy. It does not weigh in on cost, market dynamics, or political preferences. That clarity of mission is what makes it one of the most trusted regulatory bodies in the world. Straying from that focus — for example, by delaying reviews for political signaling — undermines its credibility and independence.
4. Make the U.S. more competitive for clinical development
Biotechnology is a crown jewel of the American economy, but we are in a tightening race with China, where clinical development is much faster and cheaper. Increasingly, early-stage studies are conducted in countries like Australia and the United Kingdom.
We must reverse this trend. FDA should take concrete steps to reduce regulatory friction and make the U.S. the first and best place to test innovative therapies — especially first-in-human studies for products invented here.
5. Modernize how we evaluate products after they reach the market
Biotech is pushing for “progressive approval” models, in which therapies are approved initially on limited evidence, with data collection continuing post-approval. These models hold promise but also raise serious challenges. Real-world studies, no matter how vast or AI-enhanced, are often riddled with confounding and bias. To assess new products meaningfully, we need to become far better at running large, simple, pragmatic clinical trials — quickly, affordably, and within routine care settings.
Current research regulations are ill-suited to this task. They were designed in an era in which medical products were either fully investigational or fully approved. Today, we live in the gray zone. FDA should lead this work with Congress and HHS to modernize these rules, enabling the health care system to generate reliable post-market evidence without bureaucratic paralysis.
Moreover, assessing product safety is critically important. Enormous recent progress has been made based on the ability to detect even rare side effects in large medical and insurance databases. While the system is not broken, continued improvement in safety assessment methods will increase public confidence in medical products, including vaccines and drugs.
Marty Makary has inherited a daunting task. But if he puts science, transparency, and institutional integrity first — rather than politics or expediency — he has the opportunity to strengthen the FDA for the next generation. Biotech, and the American public, are counting on it.
Luciana Borio is an infectious disease physician, a senior fellow for global health at the Council on Foreign Relations, former acting chief scientist of the U.S. Food and Drug Administration, and former director for medical and biodefense preparedness policy at the National Security Council. Phil Krause is an infectious diseases physician, an independent consultant, and former deputy director of FDA’s Office of Vaccines Research and Review.