Go Ahead, Make the Case That Science, Free Speech, and the FDA Are Thriving Under Drs. Marty Makary and Vinay Prasad

It sounds like the setup to an especially nerdy courtroom drama: “Counselor, please approach the bench and explain how science, free speech, and the FDA are all doing fantastic under Drs. Marty Makary and Vinay Prasad.”
The title, inspired by a critique on Science-Based Medicine, is deliberately provocative. It asks a simple but loaded question: now that two very vocal critics of pandemic policy and FDA decision-making have stepped into positions of power, are we witnessing a renaissance of evidence, openness, and regulatory sanityor just a differently flavored version of politics as usual?

To answer that, we need to unpack who Makary and Prasad are, what they say they’re doing, what their critics say they’re actually doing, and how all of this plays out in real-world science, free speech debates, and the FDA’s day-to-day work.

Who Are Drs. Marty Makary and Vinay Prasad, and Why Do They Matter?

Marty Makary: From Media Contrarian to FDA Commissioner

Dr. Marty Makary is a surgeon and health policy expert who built his brand long before he took the helm of the U.S. Food and Drug Administration. He rose to prominence through books, op-eds, and cable news appearances, casting himself as a reformer willing to challenge medical groupthink. During the COVID-19 pandemic, he supported vaccines but opposed mandates, questioned the push for universal boosters in younger people, and criticized certain school-masking policies as not backed by strong evidence.

Supporters see him as the guy who dared to say, “Show me the data,” when public health messaging got overly confident. Critics argue that he sometimes overstated vaccine risks and understated the dangers of the virus, contributing to confusion in an already chaotic information landscape. That tensionbetween “bold truth-teller” and “high-profile oversimplifier”now follows him directly into the FDA commissioner’s office.

Vinay Prasad: Evidence Warrior Turned Vaccine Regulator

Dr. Vinay Prasad is an oncologist and researcher known for his work on evidence-based medicine, overdiagnosis, and overtreatment. Long before joining the FDA, he became famous (or infamous, depending on your timeline) for critiquing weak oncology trials, surrogate endpoints, and the agency’s accelerated approval pathway.

As the new head of the FDA’s Center for Biologics Evaluation and Research (CBER)the branch that oversees vaccines and biologicsPrasad now sits at the control panel he has spent years lambasting. On paper, he is the kind of skeptic a lot of reformers claim they want: someone who demands randomized controlled trials and hard outcomes instead of marketing-friendly but flimsy evidence. In practice, though, his contrarian commentary on COVID vaccines and mandates has raised alarms among scientists who worry he has downplayed vaccine benefits and amplified fears out of proportion to the data.

Put together, Makary and Prasad represent a fascinating experiment: What happens when two sharp critics of “the system” are suddenly the system?

Are They Making FDA Science Strongeror Just Louder?

The Reform Agenda: “Gold-Standard Science” Meets Real-World Bureaucracy

In a widely discussed policy piece, Makary and Prasad outlined “priorities for a new FDA,” promising policies grounded in “gold-standard science and common sense.” They highlighted bloated submission dossiers, unclear benefit–risk communication, and a tendency to lean on questionable surrogate endpoints as problems that needed fixing. They’ve floated ideas like better harnessing data science and AI for first-pass reviews, demanding clearer evidence of benefit for costly drugs, and making the agency less cozy with industry while still approving treatments faster for serious diseases.

On paper, that sounds like science heaven: cleaner evidence, more transparency, and fewer “miracle” drugs that end up not doing much of anything. Many clinicians who are tired of marginal cancer drugs with eye-watering prices cheer the rhetoric.

But some observers warn that the details matter. Critics point out that waving through enormous submissions and leaning heavily on generative AI could just as easily muddle key signals as clarify them. Others worry that calling something “common sense” can be a way of bypassing careful, sometimes slow, scientific deliberation. In other words, the slogans sound great; the implementation will determine whether this is a win for science or for sound bites.

Prasad Versus the “Rubber Stamp” Reputation

Prasad has long attacked what he sees as a too-permissive approach to oncology and rare-disease drugsespecially when approvals are based on surrogate markers (like tumor shrinkage) instead of robust data on survival or quality of life. Now that he oversees biologics and vaccines, he is in a position to demand higher evidentiary standards and push companies toward truly informative trials.

The upside: fewer drugs that offer little benefit at huge cost, and a stronger culture of “prove it with real outcomes.” The downside: if the bar is set too high or too rigidly, promising therapies could be delayed or derailed, especially in rare diseases where huge trials are nearly impossible. Biotech investors have already signaled anxiety about a tougher, more skeptical FDA, and patient advocates for rare conditions worry that hard-line rhetoric may translate into longer waits for desperately needed options.

Internal Friction: When “Reform” Meets the Rest of the FDA

Inside the agency, not everyone is applauding. Senior officials have reportedly raised legal and scientific concerns about proposals to streamline approvals and rewire internal processes. Some worry that sidelining career scientists or minimizing advisory committees could erode the very evidence culture Makary and Prasad claim to champion. When internal memos read like “We love science, but…,” you know the reform effort is not exactly running on rails.

All of this leaves us with a nuanced picture: there are genuinely evidence-strengthening ideas on the table, but also serious questions about whether the machinery of science will be sharpenedor bentto fit political and personal narratives.

Free Speech: Robust Debate or Weaponized Dissent?

From “Silenced” Critics to the People in Charge

A big part of the Makary–Prasad story is their portrayal as free-speech martyrs during the pandemic era. Both complained about social media takedowns, platform friction, and campaigns to label their work as “misinformation.” They argued that legitimate scientific disagreements about school closures, masking, boosters, and mandates were treated as heresy rather than debate.

Fast-forward to today, and those same voices now hold powerful microphones inside the FDA. They talk about encouraging dissenting views, inviting external critics into advisory conversations, and ensuring that agency scientists aren’t punished for unpopular opinions. In theory, that could be a huge step forward for free speech within sciencewhere junior researchers often feel they must toe the party line if they want grants or promotions.

The catch, of course, is that one person’s “healthy dissent” is another person’s “harmful misinformation.” Public health experts and fact-checkers have documented instances where Makary and Prasad’s commentary on COVID vaccines appeared to emphasize uncertainties and rare risks while downplaying clear evidence of reduced hospitalization and death. When you call something “nuance” but your audience hears “the shots don’t work” or “kids don’t need vaccines at all,” the free-speech conversation starts to look less like academic freedom and more like a messaging minefield.

Is Free Speech Really Thrivingor Just Rebranded?

So, under Makary and Prasad, is free speech thriving? In one sense, yes: their own contrarian views now have institutional backing, and other skeptics may feel safer voicing criticism of mainstream public health positions. Advisory meetings are more likely to feature sharp exchanges and pointed questions about weak evidence, especially for expensive biologics and boosters.

But there’s another side. When yesterday’s dissenters become today’s deciders, there’s a real risk that the pendulum simply swings the other way. Just as earlier pandemic-era critics felt marginalized, some pro-vaccine clinicians and public health voices now worry that they will be dismissed as “fearmongers” or “pharma shills” if they support booster campaigns or flexible approval pathways. Free speech is not automatically thriving just because a new group feels empowered; it’s thriving only if people across the spectrum can argue in good faith without fear of political reprisals.

Is the FDA Itself Thriving Under Their Leadership?

Regulation in the Spotlight: Faster, Tougher, or Both?

One of the most tangible questions is whether the FDA’s core jobensuring that drugs and biologics are safe and effectiveis being done better. On one hand, Makary and Prasad have championed new pathways for ultra-rare diseases and individualized therapies, emphasizing “biological plausibility” and flexible trial designs. For families facing a deadly condition with no approved treatment, these policies sound like hope finally getting a fighting chance.

On the other hand, watchdogs worry that emphasizing speed and “plausibility” over solid data could open the door to expensive therapies that don’t meaningfully help patientsor even harm them. Investor jitters, heated opinion pieces, and testy exchanges within the agency all point to one truth: nobody thinks this is business as usual. The FDA is being reshaped in real time, and nobody yet knows whether the end result will be a leaner, smarter regulator or an agency trapped between political promises and scientific constraints.

Morale, Trust, and the Public View

Agencies don’t “thrive” on policy alone; they also run on morale and public trust. Inside the FDA, staff are navigating new leadership styles, revised priorities, and sometimes contradictory public messaging about vaccines, boosters, and approvals. That kind of turbulence can energize some people and burn out others.

Outside the agency, public trust in science and regulatory bodies remains fragile after years of pandemic polarization. When the FDA’s leaders are prominent media figures who previously accused the agency of serious failures, every decision they make is read either as “finally, someone’s fixing this mess” or “they’re tearing down safeguards.” In that climate, thriving is a very high bar.

The honest answer right now is that the FDA is in a high-stakes, rapidly evolving experiment. There are initiatives that could strengthen evidence standards and openness, and there are moves that could backfire if they privilege rhetoric over rigorous, transparent science.

So, Are Science, Free Speech, and the FDA Thriving?

If you walked into this debate hoping for a clean “yes” or “no,” sorrythis isn’t that kind of movie. Under Drs. Marty Makary and Vinay Prasad, there are signs of more vigorous scientific debate around drug approvals, more vocal insistence on hard outcomes in trials, and a willingness to question legacy practices. Those are real positives.

At the same time, their track records on pandemic communication, their tendency to frame complex risk–benefit questions in punchy media-friendly terms, and ongoing internal and external pushback suggest that the picture is cloudy at best. Science does not thrive merely because contrarians take charge; it thrives when the best evidence wins, even when it contradicts your own past takes. Free speech does not thrive merely because one faction feels freer to speak; it thrives when dissent is possible without turning every disagreement into a tribal referendum.

The fairest verdict for now might be: the jury is still out, but the courtroom is very, very loud.

From the Front Lines: Lived Experiences in the Makary–Prasad Era

It’s one thing to debate policy in op-eds and long threads; it’s another to live with the consequences. To see what this shift feels like on the ground, imagine a few different vantage points.

The Clinician in the Middle

Picture an infectious disease specialist at a community hospital. Before, they were told to “follow CDC and FDA guidance” almost without question. Now, they’re in staff meetings where people quote Makary or Prasad to argue for fewer boosters or to question the approval of certain biologics. The doctor appreciates that more staff are reading studies and asking questionsthat’s good. But they also spend more time explaining that a single provocative podcast episode is not, in fact, a systematic review.

When the FDA adjusts vaccine recommendations or reevaluates a biologic approval, this clinician has to translate a nuanced regulatory decision into a 10-minute conversation with a worried patient. The benefit of a more skeptical FDA is that they can say, “This was held to a high bar.” The cost is that shifting rhetoric and high-profile commentary can blur the line between “we’re being more rigorous” and “we’re not sure what to recommend anymore.”

The Patient Advocate for Rare Disease

Now consider a parent advocating for a child with a rare genetic condition. For years, they’ve been told that the disease is “too rare” for large traditional trials. When they hear Makary and Prasad talk about new pathways for individualized, plausible-mechanism therapies, it sounds like the first ray of light breaking through the fog.

In meetings with other families and FDA staff, they sense both excitement and anxiety. Advocates push for flexibility: “We can’t wait 10 years for perfect evidence.” FDA staff remind them that “perfect” is not the goalbut “good enough to be confident we’re helping more than harming” still matters. The Makary–Prasad era feels like a door opening, but also like the floor beneath that door has not been fully inspected yet.

The FDA Scientist Trying to Do the Right Thing

Inside the agency, imagine a career biostatistician who has worked through multiple commissioners. They are used to pressure from all directions: industry wants speed, patients want hope, and politicians want good headlines. Under Makary and Prasad, that pressure is now accompanied by a different kind of spotlight. Colleagues debate contrarian podcasts in the break room; internal guidance documents get revised with new buzzwords about “common sense” and “biological plausibility.”

This scientist appreciates that leadership talks openly about conflicts of interest and weak evidence. But they also worry when complex design questions are framed as simple “yes/no” culture-war issues outside the agency. They want space to say, “The data are messy, and we need more time,” without being cast as part of a faceless bureaucracy blocking innovationor as a partisan actor on either side.

The Health Journalist Covering the Beat

Finally, think about a health policy journalist who has been tracking the FDA for years. Their inbox is now a mix of glowing praise (“Finally, someone cleaning house!”) and dire warnings (“They’re going to kill patients with their ideology!”). Every new guidance, pathway, or public statement by Makary or Prasad triggers waves of hot takes before the underlying documents are fully read.

The journalist’s job has never been more importantor more exhausting. They have to explain why tougher evidence standards for some drugs can coexist with faster, more flexible pathways for others. They must remind readers that the FDA is not a single person with a Twitter account but a sprawling institution full of people who quietly spend their days reading data tables. The Makary–Prasad era gives them more drama to write about, but it also demands extra effort to keep nuance alive in an ecosystem that rewards outrage.

Put all these vantage points together, and you get a more human picture of what it means to ask whether “science, free speech, and the FDA are thriving.” On the ground, it feels less like a triumphant slogan and more like an ongoing, sometimes chaotic, negotiation. There are genuine attempts to strengthen evidence, real concerns about rhetoric outpacing data, and countless peopleclinicians, patients, scientists, journaliststrying to make sense of it all.

If there is one lesson from these lived experiences, it’s this: institutions don’t thrive because a few high-profile leaders say they are thriving. They thrive when the daily practices of evidence, transparency, and humility become boringly normal. Whether the Makary–Prasad chapter moves us toward that kind of boring excellence is a question that only timeand a lot of careful, public datacan answer.