🧠 The End of Fukuyama’s History?
Tariffs, Trials, and Two Theories on the FDA’s Future
In the early ’90s, political theorist Francis Fukuyama declared the “end of history.”
Not that events would stop—but that liberal democracy and global capitalism had won. Open borders. Free trade. A peaceful Pax Americana.
And for a while, it looked like he was right.
But fast forward to 2024, and the return of Trump-era economic nationalism has flipped that thesis on its head. Tariffs, reshoring, and regulatory fragmentation have reintroduced volatility into every industry—including clinical research.
🏭 Eli Lilly’s $500 Million Hedge
Before the latest headlines, Eli Lilly and Company had already committed to a $500M U.S. manufacturing facility. On the surface, it’s about making drugs at home. But behind the scenes? It’s about hedging against geopolitical risk and supply chain fragility.
But there’s a cost.
Tariffs on pharmaceutical imports could inflate R&D budgets, forcing companies to pull back on innovation. As economist William Padula warned on ABC News, this could result in fewer novel therapies—especially in areas like cancer and rare disease.
🇺🇸 Monica’s FDA Theory: Bring the Research Home
In a recent interview, Monica Cuitiva B.S, B.A ., CRC , co-founder of SOS Save Our Sites , shared a bold idea:
The FDA might begin quietly deprioritizing foreign clinical data as part of a push to “bring research home.”
Her theory? That as tariffs disrupt global logistics, the FDA—aligned with an America-first agenda—could subtly incentivize U.S.-based clinical trials, giving domestic data more weight in regulatory review.
This shift would not only pressure foreign pharma firms to run U.S. trials—but also relocalize clinical research investments, potentially benefiting independent sites, CROs, and U.S.-based patients.
I plan on writing an in-depth article on new FDA commissioner's ( Marty Makary M.D., M.P.H. ) 1 hour interview with Megyn Kelly in the next few weeks after I unpack things further. I have also sent him a Hail Mary, long shot request to join me on my podcast so here is to the Universe and making that happen.
⚖️ Darshan’s Counterpoint: That’s Wishful Thinking
I ran Monica’s idea by Darshan Kulkarni , regulatory attorney and pharmacist.
His response?
“If the goal is lower drug prices, pushing trials back into the U.S. makes no sense—it’s just more expensive. The FDA isn’t likely to make that move.”
Darshan also pointed out that RFK Jr.’s FDA focus may be elsewhere—environmental toxins, food safety—not trial geography.
While Monica’s theory reflects a strategic optimism, Darshan believes economics and global infrastructure will win out, especially as sites in India, Eastern Europe, Brazil, and Mexico continue to offer speed and cost-efficiency.
Still, both (as well as myself) agreed: China’s era as a U.S. trial partner is fading, due to IP concerns, cybersecurity issues, and growing geopolitical tension.
🔬 The FDA Is Already Signaling Change
Separate from the trial location debate, the FDA recently announced it will phase out animal testing requirements for monoclonal antibodies and certain drugs—favoring AI-based models and organ-on-a-chip platforms instead.
This shift adds new pressure on Contract Research Organizations (CROs), who must now:
The message is clear: the FDA is modernizing quietly, whether the global system is ready or not.
The analysis below by BowTiedBiotech on X is spot on for what I believe the FDA is considering:
🌍 The Bigger Picture: Global Fragility
A recent White House executive order under Section 232 is now soliciting public comments on the U.S. pharmaceutical supply chain.
Key questions include:
Darshan noted that even if drugs are “made in the U.S.,” many raw ingredients come from abroad. As he put it:
“You can mix it in a U.S. kitchen—but the ingredients still come from somewhere.”
🤖 So Where Does This Leave Us?
Here’s what we’re seeing:
✅ Drugmakers re-shoring operations
✅ The FDA modernizing its toolkit
✅ Monica sees opportunity in regulatory realignment
✅ Darshan sees a system too cost-sensitive to change
✅ China out, but global outsourcing still very much in play
🧩 The Real Fukuyama Test
Fukuyama imagined a world of ideological convergence. Instead, we’re getting strategic fragmentation—with nations reclaiming their borders, industries, and data pipelines.
As Monica told me:
“Constraints lead to innovation. We don’t know what this moment will be called—but like COVID, it’ll leave behind new business models and technologies.”
Darshan’s take?
“This is disruption. But disruption doesn’t always mean transformation.”
Maybe the “end of history” wasn’t an end. Maybe it’s just the part where we hit Control + Alt + Delete.
💬 What Do You Think?
Will the FDA shift toward domestic trials? Will tariffs reset the clinical research landscape—or just slow it down?
Leave a comment, repost, and let’s keep this conversation going.
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Drug development professional
3moWhen considering where your clinical data will be coming from in 18 months time, you almost have to hedge to a US centric strategy. But if we all do that, we go straight back to the early 2000’s when competition for patients in the US drove the wave of patient globalisation (I was working for Quintiles Singapore at the time and saw it first hand).