Next week, I will attend the graduation of my youngest daughter from George Washington University, just blocks away from where I spent twelve productive years of my professional life with the FDA. It will be my first return to the area since retirement. Time has moved on. Washington has changed. America has changed. And the FDA I once knew is now standing at another historic crossroads.
For twelve years, I was privileged to work within one of the world’s most respected scientific regulatory agencies. The FDA was never perfect. Bureaucracy could be maddening. Decisions often moved painfully slow. But beneath the layers of regulations and paperwork was a deeply rooted culture of scientific rigor and public service. The scientists, physicians, pharmacists, statisticians, inspectors, and administrators I worked with believed that protecting the American public was a sacred responsibility.
Our work was largely invisible to ordinary Americans. Yet every prescription bottle, every medical device, every food safety recall carried fingerprints of thousands of dedicated federal employees who labored quietly behind the scenes.
Back then, political administrations came and went, but the FDA’s scientific core remained relatively stable. Republican or Democrat, the agency’s mission endured: evaluate evidence, follow the science, and protect public health.
Today, however, the FDA finds itself caught in the center of America’s political and cultural wars.
Under the second administration of Donald Trump and the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., the agency has undergone dramatic upheaval. Staffing cuts, leadership turnover, disputes over vaccines, vaping regulations, food additives, and accelerated drug approvals have generated growing concern among former FDA professionals and public health experts.
Now comes the latest shockwave. Multiple news organizations reported this week that President Trump has reportedly signed off on plans to remove current FDA Commissioner Marty Makary amid internal conflicts and mounting criticism from various political factions. Although the White House has not formally confirmed the dismissal, the mere public discussion of firing yet another FDA commissioner underscores how politically fragile the agency’s leadership has become.
Ironically, Dr. Makary himself entered office as a reform-minded physician promising transparency and modernization. He advocated for faster approvals, AI-assisted reviews, reducing certain clinical trial requirements, and challenging what he viewed as outdated institutional thinking. Yet his tenure quickly became entangled in controversies involving flavored vaping products, abortion-related drug policies, vaccine standards, and tensions with both industry and political allies.
As I reflect on my own years at the FDA, I cannot help but feel both pride and concern.
Pride because I witnessed firsthand the caliber of public servants who devoted their careers to protecting Americans they would never meet. Many sacrificed higher private-sector salaries because they believed in the mission. Some worked late nights reviewing clinical data that could determine whether a cancer drug reached desperate patients. Others inspected manufacturing plants to ensure safety standards most consumers never think about.
But I also feel concern because public trust in institutions has eroded dramatically in modern America. Science itself has become politicized. Expertise is often dismissed as elitism. Federal agencies are increasingly viewed through partisan lenses instead of as guardians of the public good.
The FDA has always balanced competing pressures - industry demands, political oversight, patient advocacy, and scientific uncertainty. But the current environment feels more combustible than anything I remember during my years there.
And yet, as I prepare to walk once again through Washington’s familiar streets, I am reminded that institutions ultimately endure because of people, not politicians. Administrations change. Commissioners come and go. Headlines fade. But somewhere inside FDA offices tonight, career scientists are still reviewing data, inspecting facilities, and making difficult decisions that affect millions of lives.
That continuity matters.
My daughter’s graduation also symbolizes something larger. One generation steps forward as another reflects backward. When I retired in 2002, I believed my chapter with the FDA had closed forever. But perhaps returning now offers a chance to appreciate not only how much America has changed, but also how vital principled public service remains.
The FDA I knew was built on the belief that science, integrity, and public trust mattered. I still want to believe that beneath today’s political storms, those values can survive for the next generation.
- Faster Approvals & User Fees: The 1992 Prescription Drug User Fee Act (PDUFA) revolutionized the agency by allowing the FDA to collect fees from drug manufacturers to accelerate the review process.
- Drug Approval Times: Drug approval times were cut in half during this period, from roughly 30 months down to 15 months, according to 1997 White House data.
- Key Legislation:
- 1990 Nutrition Labeling and Education Act: Mandated standardized nutrition labels on food.
- 1994 Dietary Supplement Health and Education Act (DSHEA): Changed how supplements were regulated, placing them in a different category than conventional drugs.
- 1997 FDA Modernization Act (FDAMA): Furthered the goals of fast-tracking drugs for serious diseases.
- Key Issues/Events:
- Device Issues: Studies on pacemakers and ICDs during this period showed a rise in malfunction reports in the late 90s, with 61 reported deaths between 1990-2002.
- Compounding Concerns: The FDA was actively dealing with issues surrounding pharmacy compounding quality.
- Tobacco Initiative: The FDA launched efforts to increase public awareness of the adverse effects of tobacco products.
- Modernized Food Safety: The 2011 Food Safety Modernization Act (FSMA) shifted the focus from responding to contamination to preventing it.
- Global Oversight: Because of rapid globalization in the 2000s, the FDA now manages a massive global network, with staff in multiple countries inspecting imports.
- Tobacco Regulation: Following the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA now officially regulates tobacco products.
- Digital Health and Tech: The agency now has dedicated frameworks for AI in medical devices, digital health software, and advanced personalized medicines, technologies that were not in place in 2002.
- Rapid Response: Following the experience with COVID-19 (post-2020), the FDA has sharpened its ability to issue Emergency Use Authorizations (EUAs) to rapidly bring vaccines and treatments to market.
| Feature [1, 2, 3, 4, 5, 6, 7] | 1990–2002 | Today (2026) |
|---|---|---|
| Drug Approval Speed | Fast-tracking through PDUFA (92) | Ultra-fast tracks (Real-Time Oncology Review, etc.) |
| Food Safety | Reactive, responding to outbreaks | Proactive/Preventive (FSMA) |
| Technology Focus | Traditional drugs/medical devices | AI, Gene Therapy, Digital Health |
| Tobacco | Early, limited intervention | Strict regulation of tobacco/vapes |
| Global Scope | Growing imports | Intense global inspection system |
