The questions they didn't ask Marty Makary at his confirmation hearing

Senators questioned Marty Makary, but their silence on the FDA’s biggest failures was deafening.

By all accounts, Marty Makary’s confirmation hearing to lead the FDA went smoothly. As an experienced surgeon at Johns Hopkins with impeccable credentials, he handled questions with ease.

But the real issue was not what the senators asked Makary—it was what they didn’t ask him that was most concerning. They sidestepped the FDA's recent, glaring failures, leaving critical issues unaddressed.

Much of the hearing consisted of senators pressing Makary for commitments on data he had not yet reviewed, such as mifepristone, vaping, and food additives. They also questioned him about recent FDA job cuts—decisions in which he had no involvement. As a result, there were no substantive revelations.

Makary promised greater transparency at the FDA and vowed to restore public trust. But why did no one press him on the agency’s most egregious missteps?

Speedy drug approvals

One of the most troubling trends at the FDA is its increasing reliance on expedited drug approval pathways.

Today, 65% of new drugs are pushed through these faster routes, despite clear evidence linking them to greater safety risks and a higher likelihood of requiring black box warnings.

The case of Aducanumab, the controversial Alzheimer’s drug, exemplifies this problem. It was approved in 2021 based on surrogate markers rather than meaningful clinical outcomes.

Despite an almost unanimous vote against its approval by the FDA’s advisory committee, the agency proceeded regardless, leading three committee members to resign in protest.

Harvard professor of medicine Aaron Kesselheim called it “probably the worst drug approval decision in recent US history.” Yet not a single senator questioned Makary on how he planned to reform this broken system.

When drugs are rushed through accelerated pathways, companies are required to conduct confirmatory trials to confirm efficacy and safety. But these confirmatory trials are frequently delayed, never completed, or ignored when results are unfavourable.

The FDA rarely penalises companies for non-compliance, allowing unsafe or ineffective drugs to remain on the market. Yet, the senators failed to ask Makary whether he would commit to stricter enforcement of these requirements.

A culture of secrecy

The FDA is the only major drug regulator in the world that receives individual participant data from clinical trials—yet it refuses to routinely release these data for independent scrutiny. If the agency stands by its approvals, why not allow external verification?

During the Covid-19 pandemic, the FDA granted Emergency Use Authorisation (EUA) for Pfizer’s mRNA vaccine trial in just 22 days—an unrealistic timeframe for proper analysis.

Worse still, it failed to conduct trial site inspections, despite knowing billions of doses would be administered, with experts calling the FDA’s oversight “grossly inadequate.”

When whistleblower Brook Jackson provided documented evidence of scientific misconduct in Pfizer’s pivotal clinical trial, the FDA ignored her.

The agency’s own Office of Criminal Investigations, whose job it is to conduct criminal investigations into illegal activities involving FDA-regulated products, turned a blind eye.

How can the agency expect public trust when it turns ignores such evidence?

Adding to its opacity, the FDA attempted to withhold Pfizer’s vaccine trial data for 75 years, only relenting after a legal battle. The Judge in this case said the court order would “pierce the veil of administrative secrecy.”

This should have been a major topic at the hearing. I personally have had an FOIA request pending with the FDA for over three years, and the last time I checked, the agency claimed it was still "in triage."

Concealing data

The FDA knew early on that the immunity conferred by Pfizer’s mRNA vaccine waned rapidly, yet it withheld these findings for months, during which time millions of people queued to get vaccinated under the assumption they offered lasting protection.

The agency, despite promising transparency early in the pandemic, consistently delayed releasing safety data, preventing doctors and the public from making informed decisions. None of this was brought up by Senators at the hearing.

FDA’s drug promotion

The FDA is a regulatory body, not a marketing agency—yet it actively promoted Covid-19 vaccines, claiming they prevented long Covid despite no supporting evidence.

Former FDA Commissioner Robert Califf falsely stated that the Pfizer’s antiviral Paxlovid could prevent long Covid and even admitted to deliberately “cheerleading” the drug.

Meanwhile, the agency mocked alternative treatments like ivermectin, infamously tweeting: "You are not a horse, you are not a cow, seriously, y'all. Stop it." It later removed the tweet after being sued. The FDA has no business dictating treatment choices or engaging in pharmaceutical advertising.

The agency also capitulated to political pressure.

The Biden administration pushed for universal Covid-19 booster approval despite weak data, prompting the resignation of two top vaccine officials, Marion Gruber and Phillip Krause. Senators should have demanded to know exactly how Makary would prevent future political interference.

False advertising

Pfizer CEO Albert Bourla publicly claimed that the company’s Covid-19 vaccine prevented transmission, even though the FDA’s own EUA documents stated this was never assessed.

The agency did nothing to correct this false advertising, yet no senator questioned Makary about how he would address misleading pharmaceutical advertising going forward.

Nor did they raise the issue of banning direct-to-consumer advertising—a policy Robert F. Kennedy Jr. has pledged to end.

Unanswered safety questions

Despite the pandemic ending, Moderna and Pfizer vaccines for young children remain under EUA. Why? There is no emergency justifying this continued authorisation.

Moreover, independent researchers have repeatedly raised concerns about excessive residual DNA in Covid-19 mRNA vaccines. The FDA has refused to investigate these findings, even as scientists continue to warn of potential risks.

Now, legal and medical experts have petitioned the FDA, citing regulatory violations and concluding that the vaccines were “unlawfully approved.” Why was this not discussed at the hearing?

Beyond vaccines, the FDA has persistently ignored citizen petitions on other drug safety issues.

One example is its failure to update SSRI labelling to include warnings about post-SSRI sexual dysfunction (PSSD), despite overwhelming evidence. This inaction has led to legal action against the agency. Why did no senator demand accountability?

The task ahead

Makary was not responsible for the FDA’s past transgressions, but when confirmed, he inherits an agency in crisis.

To his credit, he was one of the few who publicly challenged flawed Covid policies during the pandemic.

Many hope he will now use his surgical precision to excise the rot within the FDA.

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