New FDA leadership brings cultural shift and mentality shakeup

The Food and Drug Administration is garnering praise for bringing a heightened focus to efficiency, rare diseases and food safety under new acting Commissioner Kyle Diamantas, who has already achieved success as the agency's deputy commissioner for food. 

"He made some great strides forward already in trying to get out some of the petroleum-based derivatives that are in food, the additives, bringing attention to ultra-processed foods," Kansas GOP Sen. Roger Marshall, a physician, recently told Just The News.

As the FDA''s deputy commissioner for food, Diamantas, a former food and drug attorney, led the agency's Human Foods Program with a focus on nutrition, safety, resource allocation and policy. He stepped into the top role mid-May after former Commissioner Dr. Marty Makary’s resignation. 

Similarly, Makary, a surgeon, had a number of successes hailed by the Trump administration and health-minded Americans, including record drug and device approvals, phasing out petroleum-based synthetic food dyes, improving infant formula improvements, reviewing food chemical, and launching AI-assisted regulatory tools.  

Makary also received high praise from Marshall, who called him, "the mover, the shaker, turning things upside down."

Though he led the FDA for just 13 months, he left behind a legacy known for moving toward efficiency and treating rare diseases better.

The FDA under new leadership is expected to continue Makary's mission of efficiency. 

Marshall says similar agencies in European nations focus on the safety of a drug exclusively.

"Their FDA just makes sure the drug is safe, then let doctors figure out, based on everything they know about the drug, is it efficacious enough?" he said.

The full process of bringing a new drug from initial discovery to FDA approval typically takes 10 to 15 years on average, with total capitalized costs (including failures) often estimated at $1 billion to $2.6 billion per approved drug. 

What makes those numbers so high is the early failure rate, which can be streamlined, according to former FDA senior medical analyst Dr. David Gortler. When the process is streamlined, failure rates can be more effectively detected earlier on, which translates not only to lower costs for the drug companies, but lower costs for consumers as well.

Gortler told Just The News, "the failure rate for drugs is greater than 90% for phase one, 80% for phase two, and 50% of the drugs fail phase three, after companies have already spent hundreds of millions of dollars. When you pay for a drug, you're paying for the failures as well." 

Especially with respect to treating rare diseases, Marshall said, "I think this is the balance here. Let's make sure the drug is safe, but then let the doctors and the patients have more skin in the game and make that determination if they think they should try it or not." 

Liberating the agency from corruption 

A culture shift will be required at the FDA to achieve large-scale change while bumping up against an entrenched bureaucracy. 

Gortler, whose time at the FDA also included his role overseeing FDA labeling changes and whether to recommend submitted new drug applications, warned about a culture of corruption that stems from the government-to-private-sector pipeline, from the top down. 

"A lot of people who want that position [FDA Commissioner] are people who are ambitious, Gortler cautioned. "Nine out of the last 10 commissioners have all gone to Big Pharma, and they've all got these plum jobs with multimillion-dollar-a-year salaries. And that is exactly not the person who should be running the FDA. It should be the opposite of that." 

The F in FDA

Diamantis comes into the position with an emphasis on food and related products, not just drugs. Prior to joining the FDA, his law expertise centered on advising food, dietary supplement, cosmetic, and consumer goods companies on regulatory compliance, enforcement actions, litigation and policy issues.

In February 2025, Diamantas was appointed acting Deputy Commissioner for Human Foods. In that position, he oversaw the FDA’s Human Foods Program, including nutrition and food safety activities, resource allocation, risk prioritization, policy development, response efforts and inspections. 

He also participated in setting U.S. food policy direction, collaborated with the White House and Department of Health and Human Services, engaged international partners and visited farms, ports, and border facilities to address produce safety and import compliance under the Food Safety Modernization Act. 

The U.S. food supply contains thousands of additives, preservatives, dyes, emulsifiers, and pesticide residues, many approved under the FDA’s “Generally Recognized as Safe” (GRAS) process, which allows industry self-determination for many substances. 

Several additives permitted in the U.S. are banned or restricted in the European Union due to health concerns, including certain synthetic dyes, potassium bromate and titanium dioxide. 

"We can't keep allowing the food industry to tell us what's safe and what isn't safe," Marshall advised. "We need to hold them accountable, and we need them to keep following through on their new ingredients as well as reviewing their old ones." 

Ultra-processed foods, which dominate many American diets and often contain these chemicals, have been linked in observational studies and some trials to higher risks of obesity, diabetes, heart disease, inflammation and other chronic conditions. 

Potential mechanisms include endocrine disruption (“obesogens”), gut microbiome changes, and cumulative low-dose exposures. 

Despite that, "the drugs we take and the food we eat are the most regulated things in this country. People think it's nuclear waste or cars or airplanes or guns. It's not. It's the FDA's work," Gortler said. 

Amanda Head is the White House Correspondent for Just The News. You can follow her here.