Inside the Collapse of FDA-My Reflections

This posting is my second response to the firing of about 20% of FDA employees.  Robert F. Kennedy Jr., Secretary of Health and Social Welfare publicly branded FDA employees as part of a “corrupt system” and called upon them to “preserve your sanity” or “pack your bags.” He can not be right saying it. Kennedy is totally wrong with statement above.

)Reflecting on the Collapse of the FDA: A History, and Personal Journey

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  As someone who dedicated twelve years (1990-2002) of my professional life to the U.S. Food and Drug Administration (FDA)—culminating in my role as a Chemistry Team Leader at the Center for New Drugs and participation on the Emergency Team after 9/11—the recent New York Times Magazine article “On the Collapse of the FDA” by Jeneen Interlandi (July 20, 2025) hit home on a deeply personal level. 

  
  

  The article details a transformation that many of us who served within the agency could scarcely imagine: the systematic dismantling of an institution designed to protect public health and consumer safety, now threatened under the direction of Health Secretary Robert F. Kennedy Jr.

  
  A Brief History of the FDA (for International Readers)

  Origins: The FDA has its roots in the early 20th century, growing from outrage over dangerous foods and medicines that were fraudulently sold to the public. In 1906, the Pure Food and Drug Act was signed into law, establishing the agency (then under a different name) with a mission to combat adulterated and mislabeled food and drugs.

• Growth Through Crisis: The FDA’s statutory power increased after public health tragedies—like tainted medicines and the infamous Thalidomide scandal—spurred major legal reforms, solidifying its authority to evaluate the safety and efficacy of drugs, devices, food, and cosmetics.

• A Critical Role: Today, the FDA oversees products accounting for about one-fifth of every dollar spent by Americans, from prescription drugs and medical devices to food, cosmetics, and tobacco. Yet, throughout its history, the FDA has labored under constraints: limited funding, outdated technology, and a legislative environment often favoring corporate interests over public protection.

Key Takeaways from “On the Collapse of the FDA”

• How the Dismantling Began: According to the article, Robert F. Kennedy Jr., recently confirmed as Health Secretary, publicly branded FDA employees as part of a “corrupt system” and called upon them to “preserve your sanity” or “pack your bags.” This marked the start of targeted workforce reductions, with almost 20% of the agency’s staff now gone, gutting several critical divisions—especially in food safety.

• Public Mistrust and Misinformation: Kennedy has leveraged modern social media to fuel skepticism and outright hostility toward the agency’s experts and its science-based mission. This is not entirely new—Americans have long had a complex relationship with regulation and personal freedom—but the scale and ferocity of today’s attacks are unprecedented.

• Resource and Structural Challenges: Even before recent changes, the FDA operated with less funding than peer agencies and struggled to keep pace with technological, legal, and market developments. Many of its systems remain outdated, and legal doctrines now force the FDA to anticipate expensive litigation against nearly every new regulation.

• Policy Shifts: Among Kennedy’s stated priorities are re-examining dietary guidelines, overhauling the approval of food additives, and increasing access to alternative therapies—including raw milk—while reducing the agency’s influence over drug and vaccine policy. While some reforms might have merit, the wholesale depletion of scientific staff threatens the FDA’s basic ability to fulfill its statutory mission of safety and public trust.

A Personal Reflection

Reading this article, I’m reminded of the immense responsibility and camaraderie we shared within the FDA—especially during national emergencies like 9/11. Our work was difficult, and often misunderstood by those outside the agency, but it was grounded in scientific rigor and a commitment to protect public health. Seeing the agency weakened—and the very idea of science-based regulation disparaged—moves me profoundly. The FDA is far from perfect, but its collapse would not simply be a bureaucratic reshuffling; it would represent a loss of trust, safety, and standards that have taken more than a century to build.

Why This Matters

For both American and international readers, the FDA has long set the global gold standard for regulatory science. Its influence has reached well beyond U.S. borders, inspiring similar agencies and protocols worldwide. The current crisis is not just a domestic issue—it’s a warning of how fragile scientific institutions can be in the face of political pressures and public misinformation.

The lessons of the FDA’s history are more relevant than ever: public trust is hard-won and easily lost, but without it, everyone is at greater risk.

https://www.nytimes.com/2025/07/08/magazine/fda-collapse-rfk-takeaways.html

How might Kennedy's dismantling of the FDA impact global trust in US health regulations 

Kennedy’s dismantling of the FDA is likely to have profound negative consequences for global trust in U.S. health regulations. The FDA has long set the worldwide benchmark for regulatory rigor and objectivity in food, drug, and device approval; its scientific and procedural standards are often mirrored by other nations and relied upon by multinational companies, health agencies, and consumers alike. Below are key anticipated impacts:

1. Erosion of the Global “Gold Standard”

The U.S. FDA is seen as the world’s most respected regulatory agency, and its decisions significantly influence the approval of medicines and products across the globe. A weakened or chaotic FDA undermines this reputation, potentially leading international regulators to question or even reject FDA-reviewed products and data.

2. Reduced Confidence in U.S. Exports and Innovation

• Global pharmaceutical and medical device companies depend upon the credibility of FDA certification to reach markets around the world. If foreign governments and consumers perceive the FDA as politicized, understaffed, or failing in scientific rigor, they may demand more local reviews, slow-walking or blocking access to new drugs and devices, and ultimately lowering U.S. export competitiveness.

• Investors might also lose confidence, resulting in reduced funding for American health innovation and a shift of research, development, and clinical trials to countries with stronger or more reliable regulatory systems.

3. Public Health Risks and Delays

• FDA workforce reductions and weakened oversight risk more dangerous or substandard products reaching both the U.S. and international markets. This could directly increase health risks everywhere U.S.-regulated products are shipped, compounding skepticism and calls for decoupling from FDA reliance in Europe, Asia, and beyond.

4. Loss of Moral and Scientific Leadership

• Previously, the FDA drove major international initiatives, such as harmonizing clinical trial data, expediting global access to breakthrough therapies, and leading pandemic responses. A diminished FDA surrenders this leadership at a time when coordinated science and public health responses are most urgently needed.

• Other regulators (particularly in the EU, Japan, or China) may fill the gap, setting international standards less influenced by rigorous U.S. science and ethics.

5. Mistrust Among Global Public and Health Professionals

• If the U.S.—historically an institutional pillar of evidence-based health regulation—signals it no longer values science-led oversight, this can feed global trends of anti-expert sentiment, regulatory skepticism, and misinformation. This could undermine not only product safety but also public faith in vaccination, food safety, and new medical technology around the world.

In Summary: Kennedy’s policies jeopardize both global health and the socioeconomic leadership of the U.S.. For decades, the world trusted that an FDA-approved product met the highest bar for safety and effectiveness. Undermining the agency may open the door to poorly regulated markets, decreased patient safety, greater global regulatory fragmentation, and the loss of America’s status as the guardian of health standards for all. 

For my involvement after the 9/11 Bombing of the World Trade Center read:

https://chateaudumer.blogspot.com/2013/09/remembering-september-11-2001.html

Lastly, My Photo of the Day