Kennedy Sizes Up FDA Conflicts of Interest

Closing the revolving regulatory door on Big Pharma “family” user fees

By John Klar, Special to The Kennedy Beacon.

[Reprinted with permission from the author and Liberty Nation News, where this article was originally published.]

Robert F. Kennedy, Jr. (Photo by Andrew Harnik/Getty Images)

Americans have become more distrustful of federal agencies in recent years, including “vaccine hesitancy” because of alleged misinformation about the safety and efficacy of COVID-19 vaccines. Robert F. Kennedy, Jr. has criticized HHS and other federal agencies for “regulatory capture” by corporate interests that profit when the government approves their products. The recent departure of FDA employee Patrizia Cavazzoni, who worked for pharmaceutical giant Pfizer, Inc. before her FDA stint, has drawn criticism as Cavazzoni returned to her former employer.

Cavazzoni was hired at Pfizer by former FDA Commissioner Scott Gottlieb, who left the agency in April 2019 to “spend more time with his family” …and then joined Pfizer’s board of directors in June of that year. The family relations appear to some to be nepotism: Pfizer’s COVID-19 vaccine sales amounted to more than $80 billion as of March 2024.

Leaving her post as director of FDA’s Center for Drug Evaluation and Research (CDER) just days before Donald Trump took office, Cavazzonni stated “Leaving CDER was an extremely difficult decision, but the time has come for me to be more present for my family….” Pfizer appears to be a big happy family for many former and future FDA employees, adding fuel to Kennedy’s campaign messaging that he planned to clean up the FDA’s act.

Regulatory capture at HHS agencies allegedly involves user fee arrangements whereby corporations contribute to the salaries of government personnel working on approvals for their products, and “revolving door” intermingling of employees who work both for large corporations and the government entities charged with policing them. Cavazzonni ticks both boxes, as a fan of user fee arrangements and a loyal Pfizer employee who took a two-year hiatus – to work at the FDA.

The Trump administration seeks to curtail user fee programs established in 1992 under the Prescription Drug User Fee Act (PDUFA), which permits pharmaceutical companies to fund the hiring of FDA staff to oversee the assessment of submitted products under “commitment letters” approved by Congress, allegedly to enhance efficiency of drug review and accelerate the approval process.

MAHA Takes Aim

Kennedy and Trump likely cannot dismantle FDA programs established under current commitment letters, but most user fee programs are due for reauthorization in September 2027. FDA staff cuts may result in eliminating programs relying on user-fee-funded staff. Remarkably, Scott Gottlieb on February 7, 2025, “publicly suggested that FDA and industry encourage Congress to extend the term of the current user fee amendments rather than renegotiate with the current administration,” according to the law firm Skadden, Arps, Slate, Meagher & Floom LLP and Associates.

For her part, Cavazzoni was also an ardent supporter of user fee programs during her tenure as head of CDER, stating in an interview that working remotely during the COVID-19 pandemic improved efficiency in administering the programs. As reported by Regulatory Focus:

“She also noted that user fee reauthorization processes moved along as parties held virtual negotiation sessions through the past several months. Public meetings will be coming later in 2021, and FDA’s user fee reauthorization packages should be ready for Congress on schedule, said Cavazzoni.”

Ironically, she also mentioned that the pharmaceutical industry and FDA share a talent pool, and that the government can’t compete with the corporate offers: “However, FDA is alert to the reality that industry is now wooing staff who have become accustomed to this flexibility by promising them the opportunity for fully remote work.” The center is now, she says, giving some hard thought to allowing more flexibility in on-site attendance requirements.

Gottleib’s and Cavazzoni’s door-revolving at the FDA is par for the administrative course. Former FDA Commissioner Mark McClellan sits on the board of Johnson & Johnson, while former FDA Commissioner Stephen Hahn perches on the board of Flagship Pioneering, creator of Moderna. Kennedy calls such shifting an ethical conflict, but industry players are all on board with jumping ship (back and forth), even if a stint at FDA or other federal agencies is merely a three-hour tour.

Slamming the Revolving FDA Door

Critics claim the system fosters unacceptable conflicts of interest. Attorney Mary Holland, who replaced Kennedy as President of Children’s Health Defense, told Liberty Nation News:

“The revolving door swings again! It is a national disgrace that people walk out of our federal regulatory health agencies and into the financially rewarding embrace of the pharmaceutical industry. I sincerely hope that HHS‘s new commitment to radical transparency includes ending this corruption between mega-corporations and the state.”

As DOGE matures into a cohesive effort to root out government graft, expect Bobby Kennedy to take a dim view of user-fee arrangements that allow Big Pharma to fund their own products at FDA with salaries for their own employees. Americans are now closely watching who makes their vaccines, and who regulates them. Calls to impose time limits between hirings and eliminate conflicts of interest inherent in close-knit user-fee structures are increasing in an environment that many see as justifiable citizen distrust of many federal agencies.

Many Americans believe they are being double-jabbed by an oligopoly of pharmaceutical manufacturers who don’t bother revolving the door but just leave it brazenly wide open. Cavazzoni’s shameless jump into Gottlieb’s Pfizer arms begs closer scrutiny of corporate-regulatory family ties. Robert F. Kennedy, Jr.’s scrupulous eyes are wide open.

Attorney-farmer John Klar hosts the Small Farm Republic Substack and podcast from his Vermont farm. His recent book is Small Farm Republic: Why Conservatives Must Embrace Local Agriculture, Reject Climate Alarmism, and Lead an Environmental Revival.